Trial Outcomes & Findings for Oxytocin or Galantamine Versus Placebo for the Treatment of Negative Symptoms and Cognitive Impairments in Schizophrenia (NCT NCT01012167)
NCT ID: NCT01012167
Last Updated: 2022-01-12
Results Overview
Mean SANS Total Score by Treatment and Week. SANS total score range = 0-85. Higher scores indicate more severe negative symptoms.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
86 participants
Primary outcome timeframe
Every other week for 6 weeks
Results posted on
2022-01-12
Participant Flow
Consented/Screened for Study-- N=86 Withdrew prior to randomization (N=28) * 2 withdrew consent * 26 did not meet inclusion criteria Randomized-- N=58
Participant milestones
| Measure |
1: Oxytocin/Placebo-galantamine
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
|
2: Galantamine/Placebo-oxytocin
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
|
3: Placebo-galantamine /Placebo-oxytocin
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
|
|---|---|---|---|
|
Overall Study
STARTED
|
17
|
20
|
21
|
|
Overall Study
Withdrawn Prior to Study Drug Exposure
|
1
|
0
|
1
|
|
Overall Study
Exposed to Study Drug
|
16
|
20
|
20
|
|
Overall Study
COMPLETED
|
15
|
18
|
17
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Oxytocin or Galantamine Versus Placebo for the Treatment of Negative Symptoms and Cognitive Impairments in Schizophrenia
Baseline characteristics by cohort
| Measure |
3: Placebo
n=20 Participants
Placebo: placebo-Galantamine 1 capsules twice a day and placebo-oxytocin 3 puffs in each nostril once a day.
|
Total
n=56 Participants
Total of all reporting groups
|
1: Oxytocin
n=16 Participants
Oxytocin: 24 IU oxytocin or placebo in a total of 6 puffs (3 puffs per nostril)daily for 6 weeks
|
2: Galantamine
n=20 Participants
Galantamine or placebo Galantamine: Galantamine will be dispensed as follows: 4 mg bid x 7 days; 8mg bid x 7days, then 12 mg bid for the last 4 weeks.
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
56 Participants
n=4 Participants
|
16 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
|
Age, Continuous
|
42.2 years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
44.9 years
STANDARD_DEVIATION 11.8 • n=4 Participants
|
47.4 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
45.8 years
STANDARD_DEVIATION 12.4 • n=7 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
56 participants
n=4 Participants
|
16 participants
n=5 Participants
|
20 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Every other week for 6 weeksPopulation: Of the 56 participants exposed to study drug, 3 withdrew before any efficacy data was collected, leaving 53 for whom at least some interim efficacy data was collected. Participants had to complete at least two weeks follow-up to be included in the symptom analysis.
Mean SANS Total Score by Treatment and Week. SANS total score range = 0-85. Higher scores indicate more severe negative symptoms.
Outcome measures
| Measure |
1: Oxytocin/Placebo-galantamine
n=15 Participants
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
|
2: Galantamine/Placebo-oxytocin
n=19 Participants
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
|
3: Placebo-galantamine /Placebo-oxytocin
n=19 Participants
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
|
|---|---|---|---|
|
Scale for the Assessment of Negative Symptoms (SANS) Total Score
Treatment Week 6
|
31.40 units on a scale
Standard Deviation 6.85
|
33.22 units on a scale
Standard Deviation 10.64
|
33.47 units on a scale
Standard Deviation 8.47
|
|
Scale for the Assessment of Negative Symptoms (SANS) Total Score
Treatment Week 0
|
33.23 units on a scale
Standard Deviation 6.91
|
36.63 units on a scale
Standard Deviation 10.09
|
36.63 units on a scale
Standard Deviation 10.61
|
|
Scale for the Assessment of Negative Symptoms (SANS) Total Score
Treatment Week 2
|
30.07 units on a scale
Standard Deviation 6.93
|
35.22 units on a scale
Standard Deviation 10.97
|
35.05 units on a scale
Standard Deviation 10.52
|
|
Scale for the Assessment of Negative Symptoms (SANS) Total Score
Treatment Week 4
|
31.27 units on a scale
Standard Deviation 7.53
|
34.06 units on a scale
Standard Deviation 10.26
|
34.22 units on a scale
Standard Deviation 9.61
|
|
Scale for the Assessment of Negative Symptoms (SANS) Total Score
Change from Week 0 at Week 2
|
-3.17 units on a scale
Standard Deviation 4.20
|
-1.41 units on a scale
Standard Deviation 3.32
|
-1.58 units on a scale
Standard Deviation 4.84
|
|
Scale for the Assessment of Negative Symptoms (SANS) Total Score
Change from Week 0 at Week 4
|
-1.97 units on a scale
Standard Deviation 4.48
|
-1.69 units on a scale
Standard Deviation 3.46
|
-1.47 units on a scale
Standard Deviation 5.64
|
|
Scale for the Assessment of Negative Symptoms (SANS) Total Score
Change from Week 0 at Week 6
|
-1.83 units on a scale
Standard Deviation 3.74
|
-2.53 units on a scale
Standard Deviation 4.34
|
-1.00 units on a scale
Standard Deviation 4.41
|
PRIMARY outcome
Timeframe: Treatment Week 0 and Week 6Population: Five subjects were unable to handle the demands of the Rapid Visual Information Processing (RVIP) test, part of the composite primary outcome measure, and did not provide valid data.
\* Composite Cognitive Primary Outcome = mean of z-scores from the Brief Assessment of Cognition in Schizophrenia (BACS) Symbol Digit test, the Hopkins Verbal Learning Test (HVLT), and the Rapid Visual Information Processing test (RVIP). Z-scores for each test were calculated as Z = (individual patient score - pooled baseline mean)/(pooled baseline standard deviation). Higher values of the composite score represent a better outcome.
Outcome measures
| Measure |
1: Oxytocin/Placebo-galantamine
n=14 Participants
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
|
2: Galantamine/Placebo-oxytocin
n=15 Participants
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
|
3: Placebo-galantamine /Placebo-oxytocin
n=16 Participants
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
|
|---|---|---|---|
|
Mean Z-Scores for Composite Cognitive Primary Outcome* by Treatment Group and Week
Treatment Week 0
|
0.23 units on a scale
Standard Deviation 0.92
|
-0.22 units on a scale
Standard Deviation 0.47
|
0.21 units on a scale
Standard Deviation 0.83
|
|
Mean Z-Scores for Composite Cognitive Primary Outcome* by Treatment Group and Week
Treatment Week 6
|
0.33 units on a scale
Standard Deviation 1
|
-0.05 units on a scale
Standard Deviation 0.68
|
0.18 units on a scale
Standard Deviation 0.69
|
|
Mean Z-Scores for Composite Cognitive Primary Outcome* by Treatment Group and Week
Change
|
0.1 units on a scale
Standard Deviation 0.37
|
0.17 units on a scale
Standard Deviation 0.44
|
0.03 units on a scale
Standard Deviation 0.41
|
SECONDARY outcome
Timeframe: Every other week for 6 weeksPopulation: Of the 56 participants exposed to study drug, 3 withdrew before any efficacy data was collected, leaving 53 for whom at least some interim efficacy data was collected. Participants had to complete at least two weeks follow-up to be included in the symptom analysis.
Mean score by treatment and week. Scores range from 0-5, with higher scores indicating a worse outcome.
Outcome measures
| Measure |
1: Oxytocin/Placebo-galantamine
n=15 Participants
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
|
2: Galantamine/Placebo-oxytocin
n=19 Participants
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
|
3: Placebo-galantamine /Placebo-oxytocin
n=19 Participants
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
|
|---|---|---|---|
|
Scale for the Assessment of Negative Symptoms (SANS) - Avolition
Treatment Week 0
|
2.94 units on a scale
Standard Deviation 0.90
|
2.91 units on a scale
Standard Deviation 0.88
|
2.44 units on a scale
Standard Deviation 0.97
|
|
Scale for the Assessment of Negative Symptoms (SANS) - Avolition
Treatment Week 2
|
2.78 units on a scale
Standard Deviation 0.77
|
2.73 units on a scale
Standard Deviation 0.74
|
2.43 units on a scale
Standard Deviation 0.93
|
|
Scale for the Assessment of Negative Symptoms (SANS) - Avolition
Treatment Week 4
|
2.85 units on a scale
Standard Deviation 1.04
|
2.74 units on a scale
Standard Deviation .084
|
2.44 units on a scale
Standard Deviation 0.94
|
|
Scale for the Assessment of Negative Symptoms (SANS) - Avolition
Treatment Week 6
|
2.88 units on a scale
Standard Deviation 0.89
|
2.74 units on a scale
Standard Deviation 0.90
|
2.41 units on a scale
Standard Deviation 0.87
|
|
Scale for the Assessment of Negative Symptoms (SANS) - Avolition
Change from Week 0 at Week 2
|
-0.15 units on a scale
Standard Deviation 0.32
|
-0.18 units on a scale
Standard Deviation 0.43
|
-0.01 units on a scale
Standard Deviation 0.57
|
|
Scale for the Assessment of Negative Symptoms (SANS) - Avolition
Change from Week 0 at Week 4
|
-0.09 units on a scale
Standard Deviation 0.31
|
-0.16 units on a scale
Standard Deviation 0.50
|
0.04 units on a scale
Standard Deviation 0.43
|
|
Scale for the Assessment of Negative Symptoms (SANS) - Avolition
Change from Week 0 at Week 6
|
-0.05 units on a scale
Standard Deviation 0.48
|
-0.16 units on a scale
Standard Deviation 0.69
|
0.05 units on a scale
Standard Deviation 0.46
|
SECONDARY outcome
Timeframe: Every other week for 6 weeksPopulation: Of the 56 participants exposed to study drug, 3 withdrew before any efficacy data was collected, leaving 53 for whom at least some interim efficacy data was collected. Participants had to complete at least two weeks follow-up to be included in the symptom analysis.
Mean score by treatment and week. Scores range from 0-5, with higher scores indicating a worse outcome.
Outcome measures
| Measure |
1: Oxytocin/Placebo-galantamine
n=15 Participants
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
|
2: Galantamine/Placebo-oxytocin
n=19 Participants
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
|
3: Placebo-galantamine /Placebo-oxytocin
n=19 Participants
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
|
|---|---|---|---|
|
Scale for the Assessment of Negative Symptoms (SANS) - Anhedonia
Treatment Week 0
|
2.42 units on a scale
Standard Deviation 0.59
|
2.60 units on a scale
Standard Deviation 0.80
|
2.66 units on a scale
Standard Deviation 0.69
|
|
Scale for the Assessment of Negative Symptoms (SANS) - Anhedonia
Treatment Week 2
|
2.42 units on a scale
Standard Deviation 0.64
|
2.59 units on a scale
Standard Deviation 0.86
|
2.58 units on a scale
Standard Deviation 0.66
|
|
Scale for the Assessment of Negative Symptoms (SANS) - Anhedonia
Treatment Week 4
|
2.27 units on a scale
Standard Deviation 0.78
|
2.46 units on a scale
Standard Deviation 0.99
|
2.60 units on a scale
Standard Deviation 0.64
|
|
Scale for the Assessment of Negative Symptoms (SANS) - Anhedonia
Treatment Week 6
|
2.33 units on a scale
Standard Deviation 0.49
|
2.43 units on a scale
Standard Deviation 0.98
|
2.66 units on a scale
Standard Deviation 0.60
|
|
Scale for the Assessment of Negative Symptoms (SANS) - Anhedonia
Change from Week 0 at Week 2
|
0.00 units on a scale
Standard Deviation 0.37
|
-0.01 units on a scale
Standard Deviation 0.40
|
-0.08 units on a scale
Standard Deviation 0.51
|
|
Scale for the Assessment of Negative Symptoms (SANS) - Anhedonia
Change from Week 0 at Week 4
|
-0.15 units on a scale
Standard Deviation 0.68
|
-0.11 units on a scale
Standard Deviation .013
|
0.01 units on a scale
Standard Deviation 0.50
|
|
Scale for the Assessment of Negative Symptoms (SANS) - Anhedonia
Change from Week 0 at Week 6
|
-0.09 units on a scale
Standard Deviation 0.38
|
-0.14 units on a scale
Standard Deviation 0.38
|
0.12 units on a scale
Standard Deviation 0.47
|
SECONDARY outcome
Timeframe: Every other week for 6 weeksPopulation: Of the 56 participants exposed to study drug, 3 withdrew before any efficacy data was collected, leaving 53 for whom at least some interim efficacy data was collected. Participants had to complete at least two weeks follow-up to be included in the symptom analysis.
Mean score by treatment and week. Scores range from 0-5, with higher scores indicating a worse outcome.
Outcome measures
| Measure |
1: Oxytocin/Placebo-galantamine
n=15 Participants
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
|
2: Galantamine/Placebo-oxytocin
n=19 Participants
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
|
3: Placebo-galantamine /Placebo-oxytocin
n=19 Participants
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
|
|---|---|---|---|
|
Scale for the Assessment of Negative Symptoms (SANS) - Alogia
Treatment Week 0
|
0.60 units on a scale
Standard Deviation 0.61
|
0.95 units on a scale
Standard Deviation 0.65
|
0.99 units on a scale
Standard Deviation 0.69
|
|
Scale for the Assessment of Negative Symptoms (SANS) - Alogia
Treatment Week 2
|
0.44 units on a scale
Standard Deviation 0.67
|
0.89 units on a scale
Standard Deviation 0.59
|
0.89 units on a scale
Standard Deviation 0.80
|
|
Scale for the Assessment of Negative Symptoms (SANS) - Alogia
Treatment Week 4
|
0.56 units on a scale
Standard Deviation 0.70
|
0.85 units on a scale
Standard Deviation 0.50
|
0.80 units on a scale
Standard Deviation 0.61
|
|
Scale for the Assessment of Negative Symptoms (SANS) - Alogia
Treatment Week 6
|
0.56 units on a scale
Standard Deviation 0.69
|
0.78 units on a scale
Standard Deviation 0.44
|
0.69 units on a scale
Standard Deviation 0.57
|
|
Scale for the Assessment of Negative Symptoms (SANS) - Alogia
Change from Week 0 at Week 2
|
-0.16 units on a scale
Standard Deviation 0.42
|
-0.05 units on a scale
Standard Deviation 0.36
|
-0.10 units on a scale
Standard Deviation 0.35
|
|
Scale for the Assessment of Negative Symptoms (SANS) - Alogia
Change from Week 0 at Week 4
|
-0.04 units on a scale
Standard Deviation 0.41
|
-0.03 units on a scale
Standard Deviation 0.37
|
-0.17 units on a scale
Standard Deviation 0.31
|
|
Scale for the Assessment of Negative Symptoms (SANS) - Alogia
Change from Week 0 at Week 6
|
-0.04 units on a scale
Standard Deviation 0.46
|
-0.10 units on a scale
Standard Deviation 0.31
|
-0.19 units on a scale
Standard Deviation 0.31
|
SECONDARY outcome
Timeframe: Every other week for 6 weeksPopulation: Of the 56 participants exposed to study drug, 3 withdrew before any efficacy data was collected, leaving 53 for whom at least some interim efficacy data was collected. Participants had to complete at least two weeks follow-up to be included in the symptom analysis.
Mean score by treatment and week. Scores range from 0-5, with higher scores indicating a worse outcome.
Outcome measures
| Measure |
1: Oxytocin/Placebo-galantamine
n=15 Participants
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
|
2: Galantamine/Placebo-oxytocin
n=19 Participants
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
|
3: Placebo-galantamine /Placebo-oxytocin
n=19 Participants
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
|
|---|---|---|---|
|
Scale for the Assessment of Negative Symptoms (SANS) - Blunted Affect
Change from Week 0 at Week 2
|
-0.35 units on a scale
Standard Deviation 0.36
|
-0.07 units on a scale
Standard Deviation 0.36
|
-0.16 units on a scale
Standard Deviation 0.47
|
|
Scale for the Assessment of Negative Symptoms (SANS) - Blunted Affect
Treatment Week 0
|
1.67 units on a scale
Standard Deviation 0.86
|
1.96 units on a scale
Standard Deviation 1.06
|
2.21 units on a scale
Standard Deviation 0.97
|
|
Scale for the Assessment of Negative Symptoms (SANS) - Blunted Affect
Treatment Week 2
|
1.32 units on a scale
Standard Deviation 0.90
|
1.89 units on a scale
Standard Deviation 1.10
|
2.05 units on a scale
Standard Deviation 1.12
|
|
Scale for the Assessment of Negative Symptoms (SANS) - Blunted Affect
Treatment Week 4
|
1.52 units on a scale
Standard Deviation 0.91
|
1.79 units on a scale
Standard Deviation 0.99
|
1.94 units on a scale
Standard Deviation 0.98
|
|
Scale for the Assessment of Negative Symptoms (SANS) - Blunted Affect
Treatment Week 6
|
1.48 units on a scale
Standard Deviation 0.96
|
1.70 units on a scale
Standard Deviation 1.05
|
1.85 units on a scale
Standard Deviation 0.94
|
|
Scale for the Assessment of Negative Symptoms (SANS) - Blunted Affect
Change from Week 0 at Week 4
|
-0.15 units on a scale
Standard Deviation 0.44
|
-0.09 units on a scale
Standard Deviation 0.33
|
-0.19 units on a scale
Standard Deviation 0.60
|
|
Scale for the Assessment of Negative Symptoms (SANS) - Blunted Affect
Change from Week 0 at Week 6
|
-0.19 units on a scale
Standard Deviation 0.36
|
-0.17 units on a scale
Standard Deviation 0.40
|
-0.19 units on a scale
Standard Deviation 0.38
|
SECONDARY outcome
Timeframe: Every other week for 6 weeksPopulation: Safety data available for 56 participants exposed to study treatment.
The total BPRS score is calculated by adding the scores for scales #1-#18. Each scale ranges from "1=Not Present" to "7=Very Severe". Total scores range from a minimum score of 18 to a maximum score of 126. A higher total score indicates a more severe psychiatric symptom rating.
Outcome measures
| Measure |
1: Oxytocin/Placebo-galantamine
n=16 Participants
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
|
2: Galantamine/Placebo-oxytocin
n=20 Participants
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
|
3: Placebo-galantamine /Placebo-oxytocin
n=20 Participants
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
|
|---|---|---|---|
|
Brief Psychiatric Rating Scale (BPRS) - Total Score
Treatment Week 0
|
34.16 units on a scale
Standard Deviation 5.66
|
30.35 units on a scale
Standard Deviation 6.66
|
32.65 units on a scale
Standard Deviation 7.09
|
|
Brief Psychiatric Rating Scale (BPRS) - Total Score
Treatment Week 2
|
34.00 units on a scale
Standard Deviation 7.46
|
28.95 units on a scale
Standard Deviation 7.83
|
31.75 units on a scale
Standard Deviation 7.26
|
|
Brief Psychiatric Rating Scale (BPRS) - Total Score
Treatment Week 4
|
34.07 units on a scale
Standard Deviation 6.15
|
27.83 units on a scale
Standard Deviation 6.88
|
31.72 units on a scale
Standard Deviation 7.25
|
|
Brief Psychiatric Rating Scale (BPRS) - Total Score
Treatment Week 6
|
34.33 units on a scale
Standard Deviation 5.09
|
27.67 units on a scale
Standard Deviation 6.42
|
32.18 units on a scale
Standard Deviation 6.21
|
SECONDARY outcome
Timeframe: Every other week for 6 weeksPopulation: Safety data available for the 56 participants exposed to study treatment.
The psychosis score is calculated by adding the scores for scales #4 Conceptual Disorganization, #11 Suspiciousness, #12 Hallucinatory Behavior, and #15 Unusual Thought Content. Each scale ranges from "1=Not Present" to "7=Very Severe". The minimum psychosis score is 4 and the maximum psychosis score is 28. A higher score indicates a more severe psychosis rating.
Outcome measures
| Measure |
1: Oxytocin/Placebo-galantamine
n=16 Participants
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
|
2: Galantamine/Placebo-oxytocin
n=20 Participants
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
|
3: Placebo-galantamine /Placebo-oxytocin
n=20 Participants
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
|
|---|---|---|---|
|
Brief Psychiatric Rating Scale (BPRS) - Psychosis Score
Treatment Week 0
|
9.34 units on a scale
Standard Deviation 3.20
|
7.30 units on a scale
Standard Deviation 3.01
|
8.18 units on a scale
Standard Deviation 3.80
|
|
Brief Psychiatric Rating Scale (BPRS) - Psychosis Score
Treatment Week 2
|
9.40 units on a scale
Standard Deviation 3.79
|
7.21 units on a scale
Standard Deviation 3.61
|
7.90 units on a scale
Standard Deviation 3.86
|
|
Brief Psychiatric Rating Scale (BPRS) - Psychosis Score
Treatment Week 4
|
9.87 units on a scale
Standard Deviation 3.60
|
7.00 units on a scale
Standard Deviation 3.48
|
8.06 units on a scale
Standard Deviation 4.09
|
|
Brief Psychiatric Rating Scale (BPRS) - Psychosis Score
Treatment Week 6
|
9.67 units on a scale
Standard Deviation 2.87
|
6.78 units on a scale
Standard Deviation 3.21
|
7.59 units on a scale
Standard Deviation 4.35
|
SECONDARY outcome
Timeframe: Every other week for 6 weeksPopulation: Of the 56 participants exposed to study drug, 3 withdrew before any efficacy data was collected, leaving 53 for whom at least some interim efficacy data was collected. Participants had to complete at least two weeks follow-up to be included in the symptom analysis.
Total score calculated by adding scores for scales #1-#9. Each scale ranges from "0=Absent" to "3=Severe". The minimum total CDS score is 0 and the maximum total CDS score is 27. A higher score indicates a more severe depression rating.
Outcome measures
| Measure |
1: Oxytocin/Placebo-galantamine
n=15 Participants
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
|
2: Galantamine/Placebo-oxytocin
n=19 Participants
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
|
3: Placebo-galantamine /Placebo-oxytocin
n=19 Participants
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
|
|---|---|---|---|
|
Calgary Depression Scale (CDS) - Total Score
Treatment Week 0
|
2.37 units on a scale
Standard Deviation 2.70
|
0.84 units on a scale
Standard Deviation 1.07
|
1.59 units on a scale
Standard Deviation 1.54
|
|
Calgary Depression Scale (CDS) - Total Score
Treatment Week 2
|
2.20 units on a scale
Standard Deviation 2.54
|
1.05 units on a scale
Standard Deviation 1.65
|
1.00 units on a scale
Standard Deviation 1.29
|
|
Calgary Depression Scale (CDS) - Total Score
Treatment Week 4
|
2.13 units on a scale
Standard Deviation 2.13
|
0.67 units on a scale
Standard Deviation 1.28
|
0.94 units on a scale
Standard Deviation 1.97
|
|
Calgary Depression Scale (CDS) - Total Score
Treatment Week 6
|
1.67 units on a scale
Standard Deviation 2.47
|
0.50 units on a scale
Standard Deviation 0.71
|
1.29 units on a scale
Standard Deviation 1.45
|
SECONDARY outcome
Timeframe: Once during evaluation and once at the end of 6 weeks of study treatmentPopulation: Female participants who completed at least two weeks follow-up.
Mean ASEX total scores by treatment and week for female participants. Total scores are calculated by adding scores for scales #1-#5. Each scale ranges from "1=Easily/Extremely" to "6=Never/None". The minimum total ASEX score is 5 and the maximum score is 30. Lower scores indicate more positive sexual experiences.
Outcome measures
| Measure |
1: Oxytocin/Placebo-galantamine
n=2 Participants
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
|
2: Galantamine/Placebo-oxytocin
n=6 Participants
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
|
3: Placebo-galantamine /Placebo-oxytocin
n=3 Participants
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
|
|---|---|---|---|
|
Arizona Sexual Experience Questionnaire (ASEX) Female
Treatment Week 0
|
10.5 units on a scale
Standard Deviation 0.7
|
21.2 units on a scale
Standard Deviation 7.6
|
29.0 units on a scale
Standard Deviation 1.7
|
|
Arizona Sexual Experience Questionnaire (ASEX) Female
Treatment Week 6
|
13.5 units on a scale
Standard Deviation 0.7
|
19.2 units on a scale
Standard Deviation 9.3
|
30.0 units on a scale
Standard Deviation 0
|
|
Arizona Sexual Experience Questionnaire (ASEX) Female
Change
|
3.0 units on a scale
Standard Deviation 0.0
|
-2.0 units on a scale
Standard Deviation 3.5
|
0.0 units on a scale
Standard Deviation 0.0
|
SECONDARY outcome
Timeframe: Once during evaluation and once at the end of 6 weeks of study treatmentPopulation: Male participants who completed at least two weeks follow-up.
Mean ASEX total scores by treatment and week for male participants. Total scores are calculated by adding scores for scales #1-#5. Total scores are calculated by adding scores for scales #1-#5. Each scale ranges from "1=Easily/Extremely" to "6=Never/None". The minimum total ASEX score is 5 and the maximum score is 30. Lower scores indicate more positive sexual experiences.
Outcome measures
| Measure |
1: Oxytocin/Placebo-galantamine
n=14 Participants
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
|
2: Galantamine/Placebo-oxytocin
n=14 Participants
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
|
3: Placebo-galantamine /Placebo-oxytocin
n=16 Participants
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
|
|---|---|---|---|
|
Arizona Sexual Experience Questionnaire (ASEX) Male
Treatment Week 0
|
16.5 units on a scale
Standard Deviation 9.2
|
18.1 units on a scale
Standard Deviation 6.7
|
20.8 units on a scale
Standard Deviation 6.3
|
|
Arizona Sexual Experience Questionnaire (ASEX) Male
Treatment Week 6
|
17.1 units on a scale
Standard Deviation 8.5
|
20.2 units on a scale
Standard Deviation 7.5
|
21.7 units on a scale
Standard Deviation 7.7
|
|
Arizona Sexual Experience Questionnaire (ASEX) Male
Change
|
1.5 units on a scale
Standard Deviation 7.8
|
1.6 units on a scale
Standard Deviation 5.0
|
0.8 units on a scale
Standard Deviation 6.2
|
SECONDARY outcome
Timeframe: Weekly for 6 weeksPopulation: Safety data for 56 participants exposed to study treatment.
Mean diastolic blood pressure by treatment and follow-up week
Outcome measures
| Measure |
1: Oxytocin/Placebo-galantamine
n=16 Participants
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
|
2: Galantamine/Placebo-oxytocin
n=20 Participants
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
|
3: Placebo-galantamine /Placebo-oxytocin
n=20 Participants
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
|
|---|---|---|---|
|
Vital Signs - Diastolic Blood Pressure
Treatment Week 0
|
78.8 mm-Hg
Standard Deviation 8.3
|
76.6 mm-Hg
Standard Deviation 10.7
|
78.3 mm-Hg
Standard Deviation 10.1
|
|
Vital Signs - Diastolic Blood Pressure
Treatment Week 1
|
78.4 mm-Hg
Standard Deviation 9.0
|
76.2 mm-Hg
Standard Deviation 8.9
|
75.5 mm-Hg
Standard Deviation 10.8
|
|
Vital Signs - Diastolic Blood Pressure
Treatment Week 2
|
76.7 mm-Hg
Standard Deviation 9.1
|
77.5 mm-Hg
Standard Deviation 8.4
|
79.7 mm-Hg
Standard Deviation 10.6
|
|
Vital Signs - Diastolic Blood Pressure
Treatment Week 3
|
75.0 mm-Hg
Standard Deviation 10.6
|
79.1 mm-Hg
Standard Deviation 6.9
|
78.9 mm-Hg
Standard Deviation 8.1
|
|
Vital Signs - Diastolic Blood Pressure
Treatment Week 4
|
73.9 mm-Hg
Standard Deviation 8.2
|
75.1 mm-Hg
Standard Deviation 7.3
|
73.7 mm-Hg
Standard Deviation 9.7
|
|
Vital Signs - Diastolic Blood Pressure
Treatment Week 5
|
76.2 mm-Hg
Standard Deviation 8.8
|
79.2 mm-Hg
Standard Deviation 8.4
|
77.2 mm-Hg
Standard Deviation 10.9
|
|
Vital Signs - Diastolic Blood Pressure
Treatment Week 6
|
74.4 mm-Hg
Standard Deviation 8.3
|
80.7 mm-Hg
Standard Deviation 6.9
|
76.0 mm-Hg
Standard Deviation 9.9
|
SECONDARY outcome
Timeframe: Weekly for 6 weeksPopulation: Safety data for 56 participants exposed to study treatment.
Mean systolic blood pressure by treatment and follow-up week
Outcome measures
| Measure |
1: Oxytocin/Placebo-galantamine
n=16 Participants
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
|
2: Galantamine/Placebo-oxytocin
n=20 Participants
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
|
3: Placebo-galantamine /Placebo-oxytocin
n=20 Participants
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
|
|---|---|---|---|
|
Vital Signs - Systolic Blood Pressure
Treatment Week 0
|
128.4 mm-Hg
Standard Deviation 16.7
|
123.4 mm-Hg
Standard Deviation 17.3
|
132.3 mm-Hg
Standard Deviation 19.6
|
|
Vital Signs - Systolic Blood Pressure
Treatment Week 1
|
126.1 mm-Hg
Standard Deviation 16.9
|
123.9 mm-Hg
Standard Deviation 15.0
|
127.4 mm-Hg
Standard Deviation 22.1
|
|
Vital Signs - Systolic Blood Pressure
Treatment Week 2
|
121.9 mm-Hg
Standard Deviation 20.5
|
123.7 mm-Hg
Standard Deviation 13.8
|
136.2 mm-Hg
Standard Deviation 25.1
|
|
Vital Signs - Systolic Blood Pressure
Treatment Week 3
|
129.5 mm-Hg
Standard Deviation 21.1
|
127.3 mm-Hg
Standard Deviation 19.0
|
137.7 mm-Hg
Standard Deviation 17.0
|
|
Vital Signs - Systolic Blood Pressure
Treatment Week 4
|
124.8 mm-Hg
Standard Deviation 17.3
|
123.8 mm-Hg
Standard Deviation 19.0
|
129.9 mm-Hg
Standard Deviation 16.5
|
|
Vital Signs - Systolic Blood Pressure
Treatment Week 5
|
128.4 mm-Hg
Standard Deviation 20.5
|
126.9 mm-Hg
Standard Deviation 20.1
|
132.8 mm-Hg
Standard Deviation 19.5
|
|
Vital Signs - Systolic Blood Pressure
Treatment Week 6
|
124.0 mm-Hg
Standard Deviation 17.5
|
129.6 mm-Hg
Standard Deviation 16.1
|
134.5 mm-Hg
Standard Deviation 19.4
|
SECONDARY outcome
Timeframe: Weekly for 6 weeksPopulation: Safety data for 56 participants exposed to study treatment.
Mean weight (kg) by treatment and follow-up week
Outcome measures
| Measure |
1: Oxytocin/Placebo-galantamine
n=16 Participants
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
|
2: Galantamine/Placebo-oxytocin
n=20 Participants
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
|
3: Placebo-galantamine /Placebo-oxytocin
n=20 Participants
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
|
|---|---|---|---|
|
Vital Signs - Weight
Treatment Week 2
|
98.0 kg
Standard Deviation 18.9
|
97.5 kg
Standard Deviation 16.1
|
98.3 kg
Standard Deviation 18.8
|
|
Vital Signs - Weight
Treatment Week 3
|
98.0 kg
Standard Deviation 18.9
|
94.5 kg
Standard Deviation 13.8
|
98.4 kg
Standard Deviation 19.5
|
|
Vital Signs - Weight
Treatment Week 0
|
96.5 kg
Standard Deviation 18.4
|
96.2 kg
Standard Deviation 16.2
|
96.4 kg
Standard Deviation 20.0
|
|
Vital Signs - Weight
Treatment Week 1
|
97.8 kg
Standard Deviation 19.1
|
97.5 kg
Standard Deviation 16.0
|
97.9 kg
Standard Deviation 18.9
|
|
Vital Signs - Weight
Treatment Week 4
|
100.0 kg
Standard Deviation 17.9
|
95.5 kg
Standard Deviation 14.4
|
100.3 kg
Standard Deviation 17.7
|
|
Vital Signs - Weight
Treatment Week 5
|
98.1 kg
Standard Deviation 18.6
|
94.0 kg
Standard Deviation 14.6
|
100.8 kg
Standard Deviation 17.7
|
|
Vital Signs - Weight
Treatment Week 6
|
97.6 kg
Standard Deviation 18.0
|
95.1 kg
Standard Deviation 14.7
|
97.9 kg
Standard Deviation 16.3
|
SECONDARY outcome
Timeframe: Weekly for 6 weeksPopulation: Safety data for 56 participants exposed to study treatment.
Mean sitting pulse (bpm) by treatment and follow-up week
Outcome measures
| Measure |
1: Oxytocin/Placebo-galantamine
n=16 Participants
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
|
2: Galantamine/Placebo-oxytocin
n=20 Participants
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
|
3: Placebo-galantamine /Placebo-oxytocin
n=20 Participants
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
|
|---|---|---|---|
|
Vital Signs - Pulse
Treatment Week 0
|
81.2 bpm
Standard Deviation 10.4
|
86.0 bpm
Standard Deviation 14.1
|
85.2 bpm
Standard Deviation 13.4
|
|
Vital Signs - Pulse
Treatment Week 1
|
86.2 bpm
Standard Deviation 18.8
|
91.6 bpm
Standard Deviation 14.9
|
89.3 bpm
Standard Deviation 16.7
|
|
Vital Signs - Pulse
Treatment Week 2
|
82.7 bpm
Standard Deviation 17.3
|
91.3 bpm
Standard Deviation 14.2
|
87.3 bpm
Standard Deviation 15.3
|
|
Vital Signs - Pulse
Treatment Week 3
|
76.5 bpm
Standard Deviation 11.5
|
89.2 bpm
Standard Deviation 15.6
|
89.2 bpm
Standard Deviation 13.8
|
|
Vital Signs - Pulse
Treatment Week 4
|
79.6 bpm
Standard Deviation 13.2
|
88.6 bpm
Standard Deviation 12.9
|
83.7 bpm
Standard Deviation 14.2
|
|
Vital Signs - Pulse
Treatment Week 5
|
78.4 bpm
Standard Deviation 13.2
|
98.6 bpm
Standard Deviation 28.1
|
90.5 bpm
Standard Deviation 16.0
|
|
Vital Signs - Pulse
Treatment Week 6
|
76.1 bpm
Standard Deviation 15.0
|
85.2 bpm
Standard Deviation 16.6
|
84.7 bpm
Standard Deviation 12.2
|
SECONDARY outcome
Timeframe: Baseline, week 3, and week 6Population: Of the 56 participants exposed to study drug, 3 withdrew before any efficacy data was collected, leaving 53 for whom at least some interim efficacy data was collected. Participants had to complete at least two weeks follow-up to be included in the symptom analysis.
SAS total score for extrapyramidal side effects: Frequencies of greatest within-participant increase (worsening) from pre-treatment baseline, by treatment group. Total scores calculated by adding scores from scales #1-#11. Each scale ranges from "0=None/Normal" to "4=Extreme/Severe". The minimum total score is 0 and the maximum score is 44. Higher scores indicate a more severe extrapyramidal side effect rating.
Outcome measures
| Measure |
1: Oxytocin/Placebo-galantamine
n=15 Participants
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
|
2: Galantamine/Placebo-oxytocin
n=19 Participants
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
|
3: Placebo-galantamine /Placebo-oxytocin
n=19 Participants
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
|
|---|---|---|---|
|
Simpson-Angus Scale (SAS)
No worsening (0)
|
80 percentage of participants
|
63.16 percentage of participants
|
78.95 percentage of participants
|
|
Simpson-Angus Scale (SAS)
Worsening of 1
|
16.67 percentage of participants
|
10.53 percentage of participants
|
10.53 percentage of participants
|
|
Simpson-Angus Scale (SAS)
Worsening of 2
|
6.67 percentage of participants
|
15.79 percentage of participants
|
0 percentage of participants
|
|
Simpson-Angus Scale (SAS)
Worsening of 3
|
6.67 percentage of participants
|
5.26 percentage of participants
|
5.26 percentage of participants
|
|
Simpson-Angus Scale (SAS)
Worsening of 10
|
0 percentage of participants
|
0 percentage of participants
|
5.26 percentage of participants
|
|
Simpson-Angus Scale (SAS)
Worsening of 4
|
0 percentage of participants
|
5.26 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Treatment Week 0 and Week 6Population: 50 participants who completed the trial.
AIMS Total Score: Frequencies of Maximum Within- Participant Increases (worsening) from Baseline by Treatment Group. Total score calculated by adding scores from scales #1-#10. Each scale ranges from "0=None" to "4=Severe". The minimum total AIMS score is 0 and the maximum score is 40. Higher scores indicate a more severe abnormal involuntary movement rating.
Outcome measures
| Measure |
1: Oxytocin/Placebo-galantamine
n=15 Participants
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
|
2: Galantamine/Placebo-oxytocin
n=18 Participants
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
|
3: Placebo-galantamine /Placebo-oxytocin
n=17 Participants
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
|
|---|---|---|---|
|
Abnormal Involuntary Movement Scale (AIMS)
No worsening (0)
|
86.67 percentage of participants
|
77.78 percentage of participants
|
76.47 percentage of participants
|
|
Abnormal Involuntary Movement Scale (AIMS)
Worsening of 1
|
6.67 percentage of participants
|
16.67 percentage of participants
|
17.65 percentage of participants
|
|
Abnormal Involuntary Movement Scale (AIMS)
Worsening of 2
|
6.67 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Abnormal Involuntary Movement Scale (AIMS)
Worsening of 3
|
0 percentage of participants
|
0 percentage of participants
|
5.88 percentage of participants
|
|
Abnormal Involuntary Movement Scale (AIMS)
Worsening of 5
|
0 percentage of participants
|
5.56 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Once during Evaluation and once at Treatment Week 6Population: 50 participants who completed the trial.
Mean corrected QT interval (QTc) by study week and treatment.
Outcome measures
| Measure |
1: Oxytocin/Placebo-galantamine
n=15 Participants
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
|
2: Galantamine/Placebo-oxytocin
n=18 Participants
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
|
3: Placebo-galantamine /Placebo-oxytocin
n=17 Participants
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
|
|---|---|---|---|
|
Electrocardiogram (EKG)
Evaluation Week 0
|
416.5 QTc
Standard Deviation 23.1
|
419.0 QTc
Standard Deviation 26.6
|
422.6 QTc
Standard Deviation 25.5
|
|
Electrocardiogram (EKG)
Treatment Week 6
|
415.7 QTc
Standard Deviation 28.3
|
408.1 QTc
Standard Deviation 27.2
|
423.8 QTc
Standard Deviation 26.7
|
|
Electrocardiogram (EKG)
Change
|
-2.9 QTc
Standard Deviation 20.7
|
-10.2 QTc
Standard Deviation 18.3
|
0.9 QTc
Standard Deviation 20.3
|
SECONDARY outcome
Timeframe: Treatment Week 0 and Week 6Population: 50 participants who completed the trial.
For each subject, the largest increase from baseline in the global akathisia score at any visit during follow-up was calculated. The global akathisia score ranges from "0=Absent" to "5=Severe Akathisia". Higher scores indicate a more severe global rating of akathisia.
Outcome measures
| Measure |
1: Oxytocin/Placebo-galantamine
n=15 Participants
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
|
2: Galantamine/Placebo-oxytocin
n=18 Participants
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
|
3: Placebo-galantamine /Placebo-oxytocin
n=17 Participants
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
|
|---|---|---|---|
|
Barnes Akathisia Scale (BAS) - Global Score
No worsening (0)
|
93.33 percentage of participants
|
100 percentage of participants
|
94.12 percentage of participants
|
|
Barnes Akathisia Scale (BAS) - Global Score
Worsening of 1
|
6.67 percentage of participants
|
0 percentage of participants
|
5.88 percentage of participants
|
SECONDARY outcome
Timeframe: Treatment Week 0 and Week 6Population: Of the 56 participants exposed to study drug, 3 withdrew before any efficacy data was collected, leaving 53 for whom at least some interim efficacy data was collected.
Blood Oxytocin Levels by Treatment and Visit
Outcome measures
| Measure |
1: Oxytocin/Placebo-galantamine
n=16 Participants
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
|
2: Galantamine/Placebo-oxytocin
n=20 Participants
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
|
3: Placebo-galantamine /Placebo-oxytocin
n=17 Participants
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
|
|---|---|---|---|
|
Blood Oxytocin Levels
Treatment Week 0
|
18.22 pg/mL
Standard Deviation 15.52
|
13.76 pg/mL
Standard Deviation 6.96
|
14.69 pg/mL
Standard Deviation 7.99
|
|
Blood Oxytocin Levels
Treatment Week 6
|
17.22 pg/mL
Standard Deviation 17.02
|
10.11 pg/mL
Standard Deviation 3.42
|
13.21 pg/mL
Standard Deviation 9.32
|
|
Blood Oxytocin Levels
Change
|
-1.88 pg/mL
Standard Deviation 14.09
|
-2.99 pg/mL
Standard Deviation 5.2
|
-1.73 pg/mL
Standard Deviation 3.95
|
SECONDARY outcome
Timeframe: Once during evaluation and once at the end of 6 weeks of study treatmentPopulation: Available participant lab data at Evaluation and Week 6.
Alanine transaminase/serum glutamic-pyruvic transaminase (ALT/SGPT) blood levels by treatment group and visit.
Outcome measures
| Measure |
1: Oxytocin/Placebo-galantamine
n=15 Participants
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
|
2: Galantamine/Placebo-oxytocin
n=20 Participants
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
|
3: Placebo-galantamine /Placebo-oxytocin
n=20 Participants
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
|
|---|---|---|---|
|
Laboratory Measures - ALT/SGPT
Evaluation
|
22.87 U/L
Standard Deviation 8.68
|
31.26 U/L
Standard Deviation 22.93
|
27.40 U/L
Standard Deviation 19.78
|
|
Laboratory Measures - ALT/SGPT
Treatment Week 6
|
20.67 U/L
Standard Deviation 13.03
|
28.90 U/L
Standard Deviation 22.81
|
27.74 U/L
Standard Deviation 16.62
|
|
Laboratory Measures - ALT/SGPT
Change
|
-2.15 U/L
Standard Deviation 10.20
|
-2.65 U/L
Standard Deviation 6.14
|
0.31 U/L
Standard Deviation 8.10
|
SECONDARY outcome
Timeframe: Once during evaluation and once at the end of 6 weeks of study treatmentPopulation: Available participant lab data at Evaluation and Week 6.
Aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT) blood levels by treatment group and visit.
Outcome measures
| Measure |
1: Oxytocin/Placebo-galantamine
n=15 Participants
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
|
2: Galantamine/Placebo-oxytocin
n=20 Participants
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
|
3: Placebo-galantamine /Placebo-oxytocin
n=20 Participants
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
|
|---|---|---|---|
|
Laboratory Measures - AST/SGOT
Evaluation
|
19.87 U/L
Standard Deviation 5.46
|
22.68 U/L
Standard Deviation 9.68
|
22.50 U/L
Standard Deviation 9.29
|
|
Laboratory Measures - AST/SGOT
Treatment Week 6
|
20.27 U/L
Standard Deviation 8.94
|
21.45 U/L
Standard Deviation 10.16
|
23.58 U/L
Standard Deviation 9.26
|
|
Laboratory Measures - AST/SGOT
Change
|
-1.46 U/L
Standard Deviation 4.20
|
-1.53 U/L
Standard Deviation 8.13
|
1.00 U/L
Standard Deviation 5.43
|
SECONDARY outcome
Timeframe: Once during evaluation and once at the end of 6 weeks of study treatmentPopulation: Available participant lab data at Evaluation at Week 6.
Alkaline phosphatase blood level by treatment group and visit.
Outcome measures
| Measure |
1: Oxytocin/Placebo-galantamine
n=15 Participants
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
|
2: Galantamine/Placebo-oxytocin
n=20 Participants
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
|
3: Placebo-galantamine /Placebo-oxytocin
n=20 Participants
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
|
|---|---|---|---|
|
Laboratory Measures - Alkaline Phosphatase
Evaluation
|
83.47 U/L
Standard Deviation 21.56
|
83.42 U/L
Standard Deviation 16.29
|
86.40 U/L
Standard Deviation 23.37
|
|
Laboratory Measures - Alkaline Phosphatase
Treatment Week 6
|
78.73 U/L
Standard Deviation 31.09
|
82.50 U/L
Standard Deviation 20.50
|
88.95 U/L
Standard Deviation 29.67
|
|
Laboratory Measures - Alkaline Phosphatase
Change
|
-4.77 U/L
Standard Deviation 15.81
|
0.88 U/L
Standard Deviation 10.29
|
1.19 U/L
Standard Deviation 10.97
|
SECONDARY outcome
Timeframe: Once during evaluation and once at the end of 6 weeks of study treatmentPopulation: Available participant lab data at Evaluation and Week 6.
Calcium blood levels by treatment group and visit.
Outcome measures
| Measure |
1: Oxytocin/Placebo-galantamine
n=15 Participants
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
|
2: Galantamine/Placebo-oxytocin
n=20 Participants
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
|
3: Placebo-galantamine /Placebo-oxytocin
n=20 Participants
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
|
|---|---|---|---|
|
Laboratory Measures - Calcium
Change
|
0.12 mg/dL
Standard Deviation 0.33
|
-0.16 mg/dL
Standard Deviation 0.21
|
-0.03 mg/dL
Standard Deviation 0.36
|
|
Laboratory Measures - Calcium
Evaluation
|
9.53 mg/dL
Standard Deviation 0.33
|
9.36 mg/dL
Standard Deviation 0.31
|
9.58 mg/dL
Standard Deviation 0.41
|
|
Laboratory Measures - Calcium
Treatment Week 6
|
9.57 mg/dL
Standard Deviation 0.32
|
9.23 mg/dL
Standard Deviation 0.31
|
9.54 mg/dL
Standard Deviation 0.44
|
SECONDARY outcome
Timeframe: Once during evaluation and once at the end of 6 weeks of study treatmentPopulation: Available participant lab data at Evaluation and Week 6.
Sodium blood levels by treatment group and visit.
Outcome measures
| Measure |
1: Oxytocin/Placebo-galantamine
n=15 Participants
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
|
2: Galantamine/Placebo-oxytocin
n=20 Participants
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
|
3: Placebo-galantamine /Placebo-oxytocin
n=20 Participants
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
|
|---|---|---|---|
|
Laboratory Measures - Sodium
Evaluation
|
138.53 mE/qL
Standard Deviation 2.29
|
139.53 mE/qL
Standard Deviation 2.89
|
137.30 mE/qL
Standard Deviation 4.28
|
|
Laboratory Measures - Sodium
Treatment Week 6
|
138.53 mE/qL
Standard Deviation 3.02
|
139.15 mE/qL
Standard Deviation 2.16
|
137.47 mE/qL
Standard Deviation 3.96
|
|
Laboratory Measures - Sodium
Change
|
0.15 mE/qL
Standard Deviation 1.63
|
-0.53 mE/qL
Standard Deviation 3.22
|
0.31 mE/qL
Standard Deviation 2.82
|
SECONDARY outcome
Timeframe: Once during evaluation and once at the end of 6 weeks of study treatmentPopulation: Available participant lab data at Evaluation and Week 6.
Potassium blood levels by treatment group and visit.
Outcome measures
| Measure |
1: Oxytocin/Placebo-galantamine
n=15 Participants
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
|
2: Galantamine/Placebo-oxytocin
n=20 Participants
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
|
3: Placebo-galantamine /Placebo-oxytocin
n=20 Participants
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
|
|---|---|---|---|
|
Laboratory Measures - Potassium
Evaluation
|
4.20 mE/qL
Standard Deviation 0.47
|
4.14 mE/qL
Standard Deviation 0.31
|
4.17 mE/qL
Standard Deviation 0.28
|
|
Laboratory Measures - Potassium
Treatment Week 6
|
4.07 mE/qL
Standard Deviation 0.32
|
4.01 mE/qL
Standard Deviation 0.27
|
4.16 mE/qL
Standard Deviation 0.39
|
|
Laboratory Measures - Potassium
Change
|
-0.12 mE/qL
Standard Deviation 0.43
|
-0.15 mE/qL
Standard Deviation 0.22
|
0.00 mE/qL
Standard Deviation 0.31
|
SECONDARY outcome
Timeframe: Once during evaluation and once at the end of 6 weeks of study treatmentPopulation: Available participant lab data for Evaluation and Week 6.
Chloride blood levels by treatment group and visit.
Outcome measures
| Measure |
1: Oxytocin/Placebo-galantamine
n=15 Participants
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
|
2: Galantamine/Placebo-oxytocin
n=20 Participants
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
|
3: Placebo-galantamine /Placebo-oxytocin
n=20 Participants
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
|
|---|---|---|---|
|
Laboratory Measures - Chloride
Evaluation
|
100.60 mE/qL
Standard Deviation 2.95
|
102.79 mE/qL
Standard Deviation 3.41
|
100.15 mE/qL
Standard Deviation 4.21
|
|
Laboratory Measures - Chloride
Treatment Week 6
|
101.53 mE/qL
Standard Deviation 3.54
|
102.90 mE/qL
Standard Deviation 2.63
|
100.47 mE/qL
Standard Deviation 3.78
|
|
Laboratory Measures - Chloride
Change
|
0.62 mE/qL
Standard Deviation 1.89
|
-0.06 mE/qL
Standard Deviation 2.70
|
0.56 mE/qL
Standard Deviation 2.80
|
SECONDARY outcome
Timeframe: Once during evaluation and once at the end of 6 weeks of study treatmentPopulation: Available participant lab data for Evaluation and Week 6.
Carbon Dioxide (CO2) blood levels by treatment group and visit.
Outcome measures
| Measure |
1: Oxytocin/Placebo-galantamine
n=15 Participants
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
|
2: Galantamine/Placebo-oxytocin
n=20 Participants
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
|
3: Placebo-galantamine /Placebo-oxytocin
n=20 Participants
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
|
|---|---|---|---|
|
Laboratory Measures - CO2
Evaluation
|
23.47 mE/qL
Standard Deviation 2.13
|
22.42 mE/qL
Standard Deviation 3.01
|
23.40 mE/qL
Standard Deviation 2.52
|
|
Laboratory Measures - CO2
Treatment Week 6
|
23.27 mE/qL
Standard Deviation 2.09
|
22.50 mE/qL
Standard Deviation 2.33
|
22.83 mE/qL
Standard Deviation 2.15
|
|
Laboratory Measures - CO2
Change
|
-0.31 mE/qL
Standard Deviation 2.21
|
-0.06 mE/qL
Standard Deviation 2.77
|
-0.20 mE/qL
Standard Deviation 1.52
|
SECONDARY outcome
Timeframe: Once during evaluation and once at the end of 6 weeks of study treatmentPopulation: Available participant lab data for Evaluation and Week 6.
Total cholesterol blood levels by treatment group and visit.
Outcome measures
| Measure |
1: Oxytocin/Placebo-galantamine
n=14 Participants
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
|
2: Galantamine/Placebo-oxytocin
n=15 Participants
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
|
3: Placebo-galantamine /Placebo-oxytocin
n=15 Participants
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
|
|---|---|---|---|
|
Laboratory Measures - Cholesterol
Evaluation
|
159.18 mg/dL
Standard Deviation 19.18
|
166.07 mg/dL
Standard Deviation 35.98
|
179.60 mg/dL
Standard Deviation 37.43
|
|
Laboratory Measures - Cholesterol
Treatment Week 6
|
156.93 mg/dL
Standard Deviation 22.57
|
162.93 mg/dL
Standard Deviation 22.57
|
177.33 mg/dL
Standard Deviation 36.76
|
|
Laboratory Measures - Cholesterol
Change
|
1.50 mg/dL
Standard Deviation 12.61
|
-2.40 mg/dL
Standard Deviation 15.87
|
-11.44 mg/dL
Standard Deviation 31.52
|
SECONDARY outcome
Timeframe: Once during evaluation and once at the end of 6 weeks of study treatmentPopulation: Available participant data from Evaluation and Week 6.
High-density lipoprotein (HDL) blood levels by treatment group and visit.
Outcome measures
| Measure |
1: Oxytocin/Placebo-galantamine
n=13 Participants
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
|
2: Galantamine/Placebo-oxytocin
n=14 Participants
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
|
3: Placebo-galantamine /Placebo-oxytocin
n=14 Participants
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
|
|---|---|---|---|
|
Laboratory Measures - HDL
Evaluation
|
44.09 mg/dL
Standard Deviation 12.31
|
45.50 mg/dL
Standard Deviation 14.43
|
41.14 mg/dL
Standard Deviation 10.17
|
|
Laboratory Measures - HDL
Treatment Week 6
|
44.31 mg/dL
Standard Deviation 14.07
|
43.64 mg/dL
Standard Deviation 11.62
|
41.42 mg/dL
Standard Deviation 10.75
|
|
Laboratory Measures - HDL
Change
|
-0.70 mg/dL
Standard Deviation 6.31
|
2.11 mg/dL
Standard Deviation 3.69
|
-1.67 mg/dL
Standard Deviation 4.50
|
SECONDARY outcome
Timeframe: Once during evaluation and once at the end of 6 weeks of study treatmentPopulation: Available participant lab data for Evaluation and Week 6.
Low-density lipoprotein (LDL) blood levels by treatment group and visit.
Outcome measures
| Measure |
1: Oxytocin/Placebo-galantamine
n=13 Participants
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
|
2: Galantamine/Placebo-oxytocin
n=14 Participants
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
|
3: Placebo-galantamine /Placebo-oxytocin
n=14 Participants
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
|
|---|---|---|---|
|
Laboratory Measures - LDL
Evaluation
|
90.36 mg/dL
Standard Deviation 25.02
|
91.25 mg/dL
Standard Deviation 20.42
|
105.79 mg/dL
Standard Deviation 37.30
|
|
Laboratory Measures - LDL
Treatment Week 6
|
85.92 mg/dL
Standard Deviation 28.72
|
92.29 mg/dL
Standard Deviation 19.51
|
103.73 mg/dL
Standard Deviation 33.32
|
|
Laboratory Measures - LDL
Change
|
-0.60 mg/dL
Standard Deviation 11.58
|
-1.38 mg/dL
Standard Deviation 14.92
|
-13.00 mg/dL
Standard Deviation 26.79
|
SECONDARY outcome
Timeframe: Once during evaluation and once at the end of 6 weeks of study treatmentPopulation: Available participant lab data for Evaluation and Week 6.
Triglyceride blood levels by treatment group and visit.
Outcome measures
| Measure |
1: Oxytocin/Placebo-galantamine
n=14 Participants
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
|
2: Galantamine/Placebo-oxytocin
n=15 Participants
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
|
3: Placebo-galantamine /Placebo-oxytocin
n=15 Participants
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
|
|---|---|---|---|
|
Laboratory Measures - Triglycerides
Evaluation
|
124.55 mg/dL
Standard Deviation 60.32
|
155.20 mg/dL
Standard Deviation 118.82
|
163.47 mg/dL
Standard Deviation 102.54
|
|
Laboratory Measures - Triglycerides
Treatment Week 6
|
124.79 mg/dL
Standard Deviation 69.57
|
142.29 mg/dL
Standard Deviation 99.53
|
162.17 mg/dL
Standard Deviation 102.74
|
|
Laboratory Measures - Triglycerides
Change
|
14.00 mg/dL
Standard Deviation 40.14
|
-39.30 mg/dL
Standard Deviation 77.44
|
1.22 mg/dL
Standard Deviation 49.85
|
SECONDARY outcome
Timeframe: Once during evaluation and once at the end of 6 weeks of study treatmentPopulation: Available participant lab data for Evaluation and Week 6.
Very low density lipoprotein (VLDL) blood levels by treatment group and visit.
Outcome measures
| Measure |
1: Oxytocin/Placebo-galantamine
n=12 Participants
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
|
2: Galantamine/Placebo-oxytocin
n=13 Participants
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
|
3: Placebo-galantamine /Placebo-oxytocin
n=12 Participants
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
|
|---|---|---|---|
|
Laboratory Measures - VLDL
Evaluation
|
24.73 mg/dL
Standard Deviation 12.04
|
22.00 mg/dL
Standard Deviation 10.49
|
33.17 mg/dL
Standard Deviation 22.59
|
|
Laboratory Measures - VLDL
Treatment Week 6
|
26.75 mg/dL
Standard Deviation 13.93
|
23.62 mg/dL
Standard Deviation 9.50
|
28.00 mg/dL
Standard Deviation 14.04
|
|
Laboratory Measures - VLDL
Change
|
2.80 mg/dL
Standard Deviation 8.13
|
-3.13 mg/dL
Standard Deviation 6.31
|
-0.43 mg/dL
Standard Deviation 11.19
|
SECONDARY outcome
Timeframe: Once during evaluation and once at the end of 6 weeks of study treatmentPopulation: Available participant lab data for Evaluation and Week 6.
Glucose blood levels by treatment group and visit.
Outcome measures
| Measure |
1: Oxytocin/Placebo-galantamine
n=15 Participants
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
|
2: Galantamine/Placebo-oxytocin
n=18 Participants
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
|
3: Placebo-galantamine /Placebo-oxytocin
n=18 Participants
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
|
|---|---|---|---|
|
Laboratory Measures - Glucose
Evaluation
|
108.07 mg/dL
Standard Deviation 47.12
|
98.61 mg/dL
Standard Deviation 15.50
|
103.00 mg/dL
Standard Deviation 21.86
|
|
Laboratory Measures - Glucose
Treatment Week 6
|
99.67 mg/dL
Standard Deviation 19.53
|
102.13 mg/dL
Standard Deviation 18.13
|
112.31 mg/dL
Standard Deviation 33.36
|
|
Laboratory Measures - Glucose
Change
|
-9.23 mg/dL
Standard Deviation 30.91
|
2.00 mg/dL
Standard Deviation 20.64
|
9.77 mg/dL
Standard Deviation 16.51
|
SECONDARY outcome
Timeframe: Once during evaluation and once at the end of 6 weeks of study treatmentPopulation: Available participant lab data for Evaluation and Week 6.
Albumin blood levels by treatment group and visit.
Outcome measures
| Measure |
1: Oxytocin/Placebo-galantamine
n=15 Participants
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
|
2: Galantamine/Placebo-oxytocin
n=20 Participants
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
|
3: Placebo-galantamine /Placebo-oxytocin
n=20 Participants
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
|
|---|---|---|---|
|
Laboratory Measures - Albumin
Evaluation
|
4.39 g/dL
Standard Deviation 0.24
|
4.27 g/dL
Standard Deviation 0.31
|
4.35 g/dL
Standard Deviation 0.30
|
|
Laboratory Measures - Albumin
Treatment Week 6
|
4.38 g/dL
Standard Deviation 0.25
|
4.23 g/dL
Standard Deviation 0.27
|
4.37 g/dL
Standard Deviation 0.32
|
|
Laboratory Measures - Albumin
Change
|
0.04 g/dL
Standard Deviation 0.23
|
-0.03 g/dL
Standard Deviation 0.35
|
0.03 g/dL
Standard Deviation 0.20
|
SECONDARY outcome
Timeframe: Once during evaluation and once at the end of 6 weeks of study treatmentPopulation: Available participant lab data for Evaluation and Week 6.
Globulin blood levels by treatment group and visit.
Outcome measures
| Measure |
1: Oxytocin/Placebo-galantamine
n=14 Participants
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
|
2: Galantamine/Placebo-oxytocin
n=18 Participants
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
|
3: Placebo-galantamine /Placebo-oxytocin
n=19 Participants
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
|
|---|---|---|---|
|
Laboratory Measures - Globulin
Evaluation
|
2.72 g/dL
Standard Deviation 0.40
|
2.81 g/dL
Standard Deviation 0.42
|
2.82 g/dL
Standard Deviation 0.37
|
|
Laboratory Measures - Globulin
Treatment Week 6
|
2.58 g/dL
Standard Deviation 0.54
|
2.66 g/dL
Standard Deviation 0.51
|
2.78 g/dL
Standard Deviation 0.38
|
|
Laboratory Measures - Globulin
Change
|
-0.15 g/dL
Standard Deviation 0.63
|
-0.18 g/dL
Standard Deviation 0.38
|
-0.09 g/dL
Standard Deviation 0.21
|
SECONDARY outcome
Timeframe: Once during evaluation and once at the end of 6 weeks of study treatmentPopulation: Available participant date for Evaluation and Week 6.
Albumin to Globulin (A/G) ratio in the blood by treatment group and visit.
Outcome measures
| Measure |
1: Oxytocin/Placebo-galantamine
n=15 Participants
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
|
2: Galantamine/Placebo-oxytocin
n=18 Participants
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
|
3: Placebo-galantamine /Placebo-oxytocin
n=19 Participants
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
|
|---|---|---|---|
|
Laboratory Measures - A/G Ratio
Evaluation
|
1.65 g/dL
Standard Deviation 0.29
|
1.58 g/dL
Standard Deviation 0.27
|
1.57 g/dL
Standard Deviation 0.26
|
|
Laboratory Measures - A/G Ratio
Treatment Week 6
|
1.71 g/dL
Standard Deviation 0.64
|
1.62 g/dL
Standard Deviation 0.31
|
1.60 g/dL
Standard Deviation 0.26
|
|
Laboratory Measures - A/G Ratio
Change
|
0.04 g/dL
Standard Deviation 0.22
|
0.05 g/dL
Standard Deviation 0.18
|
0.07 g/dL
Standard Deviation 0.12
|
SECONDARY outcome
Timeframe: Once during evaluation and once at the end of 6 weeks of study treatmentPopulation: Available participant data for Evaluation and Week 6.
Bilirubin blood level by treatment group and visit.
Outcome measures
| Measure |
1: Oxytocin/Placebo-galantamine
n=15 Participants
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
|
2: Galantamine/Placebo-oxytocin
n=20 Participants
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
|
3: Placebo-galantamine /Placebo-oxytocin
n=19 Participants
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
|
|---|---|---|---|
|
Laboratory Measures - Bilirubin
Evaluation
|
0.45 mg/dL
Standard Deviation 0.29
|
0.35 mg/dL
Standard Deviation 0.19
|
0.40 mg/dL
Standard Deviation 0.26
|
|
Laboratory Measures - Bilirubin
Treatment Week 6
|
0.49 mg/dL
Standard Deviation 0.24
|
0.39 mg/dL
Standard Deviation 0.24
|
0.38 mg/dL
Standard Deviation 0.15
|
|
Laboratory Measures - Bilirubin
Change
|
0.03 mg/dL
Standard Deviation 0.13
|
0.05 mg/dL
Standard Deviation 0.23
|
0.03 mg/dL
Standard Deviation 0.13
|
SECONDARY outcome
Timeframe: Once during evaluation and once at the end of 6 weeks of study treatmentPopulation: Available participant data for Evaluation and Week 6.
Protein blood level by treatment group and visit.
Outcome measures
| Measure |
1: Oxytocin/Placebo-galantamine
n=15 Participants
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
|
2: Galantamine/Placebo-oxytocin
n=20 Participants
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
|
3: Placebo-galantamine /Placebo-oxytocin
n=20 Participants
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
|
|---|---|---|---|
|
Laboratory Measures - Protein
Evaluation
|
7.10 g/dL
Standard Deviation 0.32
|
7.07 g/dL
Standard Deviation 0.41
|
7.17 g/dL
Standard Deviation 0.40
|
|
Laboratory Measures - Protein
Treatment Week 6
|
7.14 g/dL
Standard Deviation 0.42
|
6.92 g/dL
Standard Deviation 0.45
|
7.15 g/dL
Standard Deviation 0.42
|
|
Laboratory Measures - Protein
Change
|
0.07 g/dL
Standard Deviation 0.30
|
-0.13 g/dL
Standard Deviation 0.34
|
-0.04 g/dL
Standard Deviation 0.37
|
SECONDARY outcome
Timeframe: Once during evaluation and once at the end of 6 weeks of study treatmentPopulation: Available participant data for Evaluation and Week 6.
BUN blood level by treatment group and visit.
Outcome measures
| Measure |
1: Oxytocin/Placebo-galantamine
n=15 Participants
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
|
2: Galantamine/Placebo-oxytocin
n=20 Participants
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
|
3: Placebo-galantamine /Placebo-oxytocin
n=20 Participants
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
|
|---|---|---|---|
|
Laboratory Measures - BUN
Evaluation
|
12.80 mg/dL
Standard Deviation 4.92
|
10.74 mg/dL
Standard Deviation 3.18
|
11.95 mg/dL
Standard Deviation 4.10
|
|
Laboratory Measures - BUN
Treatment Week 6
|
12.73 mg/dL
Standard Deviation 4.85
|
11.55 mg/dL
Standard Deviation 3.41
|
12.00 mg/dL
Standard Deviation 4.76
|
|
Laboratory Measures - BUN
Change
|
0.15 mg/dL
Standard Deviation 2.82
|
1.06 mg/dL
Standard Deviation 3.07
|
-0.06 mg/dL
Standard Deviation 3.38
|
SECONDARY outcome
Timeframe: Weekly for 6 weeksPopulation: Safety data for 56 participants exposed to study treatment.
Percentage of participants with new onset or worsening compared to baseline of "Abdominal Pain" rating on the SEC, by Treatment Group.
Outcome measures
| Measure |
1: Oxytocin/Placebo-galantamine
n=16 Participants
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
|
2: Galantamine/Placebo-oxytocin
n=20 Participants
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
|
3: Placebo-galantamine /Placebo-oxytocin
n=20 Participants
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
|
|---|---|---|---|
|
Side Effect Checklist (SEC) - Abdominal Pain
|
12.5 percentage of participants
|
5.0 percentage of participants
|
10.0 percentage of participants
|
SECONDARY outcome
Timeframe: Weekly for 6 weeksPopulation: Safety data for 56 participants exposed to study treatment.
Percentage of participants with new onset or worsening compared to baseline of "Anorexia" rating on the SEC, by Treatment Group.
Outcome measures
| Measure |
1: Oxytocin/Placebo-galantamine
n=16 Participants
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
|
2: Galantamine/Placebo-oxytocin
n=20 Participants
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
|
3: Placebo-galantamine /Placebo-oxytocin
n=20 Participants
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
|
|---|---|---|---|
|
Side Effect Checklist (SEC) - Anorexia
|
18.8 percentage of participants
|
10.0 percentage of participants
|
15.0 percentage of participants
|
SECONDARY outcome
Timeframe: Weekly for 6 weeksPopulation: Safety data for 56 participants exposed to study treatment.
Percentage of participants with new onset or worsening compared to baseline of "Bruising Easily" rating on the SEC, by Treatment Group.
Outcome measures
| Measure |
1: Oxytocin/Placebo-galantamine
n=16 Participants
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
|
2: Galantamine/Placebo-oxytocin
n=20 Participants
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
|
3: Placebo-galantamine /Placebo-oxytocin
n=20 Participants
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
|
|---|---|---|---|
|
Side Effect Checklist (SEC) - Bruising Easily
|
0.0 percentage of participants
|
10.0 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Weekly for 6 weeksPopulation: Safety data for 56 participants exposed to study treatment.
Percentage of participants with new onset or worsening compared to baseline of "Constipation" rating on the SEC, by Treatment Group.
Outcome measures
| Measure |
1: Oxytocin/Placebo-galantamine
n=16 Participants
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
|
2: Galantamine/Placebo-oxytocin
n=20 Participants
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
|
3: Placebo-galantamine /Placebo-oxytocin
n=20 Participants
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
|
|---|---|---|---|
|
Side Effect Checklist (SEC) - Constipation
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Weekly for 6 weeksPopulation: Safety data for 56 participants exposed to study treatment.
Percentage of participants with new onset or worsening compared to baseline of "Diarrhea" rating on the SEC, by Treatment Group.
Outcome measures
| Measure |
1: Oxytocin/Placebo-galantamine
n=16 Participants
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
|
2: Galantamine/Placebo-oxytocin
n=20 Participants
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
|
3: Placebo-galantamine /Placebo-oxytocin
n=20 Participants
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
|
|---|---|---|---|
|
Side Effect Checklist (SEC) - Diarrhea
|
18.8 percentage of participants
|
30.0 percentage of participants
|
5.0 percentage of participants
|
SECONDARY outcome
Timeframe: Weekly for 6 weeksPopulation: Safety data for 56 participants exposed to study treatment.
Percentage of participants with new onset or worsening compared to baseline of "Dizziness" rating on the SEC, by Treatment Group.
Outcome measures
| Measure |
1: Oxytocin/Placebo-galantamine
n=16 Participants
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
|
2: Galantamine/Placebo-oxytocin
n=20 Participants
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
|
3: Placebo-galantamine /Placebo-oxytocin
n=20 Participants
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
|
|---|---|---|---|
|
Side Effect Checklist (SEC) - Dizziness
|
18.8 percentage of participants
|
30.0 percentage of participants
|
5.0 percentage of participants
|
SECONDARY outcome
Timeframe: Weekly for 6 weeksPopulation: Safety data for 56 participants exposed to study treatment minus 6 participants who had missing "dry eye" data.
Percentage of participants with new onset or worsening compared to baseline of "Dry Eye" rating on the SEC, by Treatment Group.
Outcome measures
| Measure |
1: Oxytocin/Placebo-galantamine
n=15 Participants
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
|
2: Galantamine/Placebo-oxytocin
n=18 Participants
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
|
3: Placebo-galantamine /Placebo-oxytocin
n=17 Participants
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
|
|---|---|---|---|
|
Side Effect Checklist (SEC) - Dry Eye
|
6.7 percentage of participants
|
0.0 percentage of participants
|
5.9 percentage of participants
|
SECONDARY outcome
Timeframe: Weekly for 6 weeksPopulation: Safety data for 56 participants exposed to study treatment.
Percentage of participants with new onset or worsening compared to baseline of "Dry Mouth" rating on the SEC, by Treatment Group.
Outcome measures
| Measure |
1: Oxytocin/Placebo-galantamine
n=16 Participants
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
|
2: Galantamine/Placebo-oxytocin
n=20 Participants
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
|
3: Placebo-galantamine /Placebo-oxytocin
n=20 Participants
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
|
|---|---|---|---|
|
Side Effect Checklist (SEC) - Dry Mouth
|
18.8 percentage of participants
|
5.0 percentage of participants
|
10.0 percentage of participants
|
SECONDARY outcome
Timeframe: Weekly for 6 weeksPopulation: Safety data for 56 participants exposed to study treatment.
Percentage of participants with new onset or worsening compared to baseline of "Enuresis" rating on the SEC, by Treatment Group.
Outcome measures
| Measure |
1: Oxytocin/Placebo-galantamine
n=16 Participants
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
|
2: Galantamine/Placebo-oxytocin
n=20 Participants
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
|
3: Placebo-galantamine /Placebo-oxytocin
n=20 Participants
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
|
|---|---|---|---|
|
Side Effect Checklist (SEC) - Enuresis
|
25.0 percentage of participants
|
5.0 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Weekly for 6 weeksPopulation: Safety data for 56 participants exposed to study treatment minus 6 participants who had missing "excessive tearing of the eye" data.
Percentage of participants with new onset or worsening compared to baseline of "Excessive Tearing of the Eye" rating on the SEC, by Treatment Group.
Outcome measures
| Measure |
1: Oxytocin/Placebo-galantamine
n=15 Participants
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
|
2: Galantamine/Placebo-oxytocin
n=18 Participants
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
|
3: Placebo-galantamine /Placebo-oxytocin
n=17 Participants
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
|
|---|---|---|---|
|
Side Effect Checklist (SEC) - Excessive Tearing of the Eye
|
6.7 percentage of participants
|
5.6 percentage of participants
|
5.9 percentage of participants
|
SECONDARY outcome
Timeframe: Weekly for 6 weeksPopulation: Safety data for 56 participants exposed to study treatment.
Percentage of participants with new onset or worsening compared to baseline of "Fever" rating on the SEC, by Treatment Group.
Outcome measures
| Measure |
1: Oxytocin/Placebo-galantamine
n=16 Participants
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
|
2: Galantamine/Placebo-oxytocin
n=20 Participants
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
|
3: Placebo-galantamine /Placebo-oxytocin
n=20 Participants
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
|
|---|---|---|---|
|
Side Effect Checklist (SEC) - Fever
|
0.0 percentage of participants
|
5.0 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Weekly for 6 weeksPopulation: Safety data for 56 participants exposed to study treatment.
Percentage of participants with new onset or worsening compared to baseline of "Headache" rating on the SEC, by Treatment Group.
Outcome measures
| Measure |
1: Oxytocin/Placebo-galantamine
n=16 Participants
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
|
2: Galantamine/Placebo-oxytocin
n=20 Participants
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
|
3: Placebo-galantamine /Placebo-oxytocin
n=20 Participants
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
|
|---|---|---|---|
|
Side Effect Checklist (SEC) - Headache
|
12.5 percentage of participants
|
25.0 percentage of participants
|
15.0 percentage of participants
|
SECONDARY outcome
Timeframe: Weekly for 6 weeksPopulation: Safety data for 56 participants exposed to study treatment minus 6 participants who had missing "Hyperhydrosis" data.
Percentage of participants with new onset or worsening compared to baseline of "Hyperhydrosis" rating on the SEC, by Treatment Group.
Outcome measures
| Measure |
1: Oxytocin/Placebo-galantamine
n=15 Participants
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
|
2: Galantamine/Placebo-oxytocin
n=18 Participants
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
|
3: Placebo-galantamine /Placebo-oxytocin
n=17 Participants
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
|
|---|---|---|---|
|
Side Effect Checklist (SEC) - Hyperhydrosis
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Weekly for 6 weeksPopulation: Safety data for 56 participants exposed to study treatment.
Percentage of participants with new onset or worsening compared to baseline of "Hypersalivation" rating on the SEC, by Treatment Group.
Outcome measures
| Measure |
1: Oxytocin/Placebo-galantamine
n=16 Participants
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
|
2: Galantamine/Placebo-oxytocin
n=20 Participants
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
|
3: Placebo-galantamine /Placebo-oxytocin
n=20 Participants
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
|
|---|---|---|---|
|
Side Effect Checklist (SEC) - Hypersalivation
|
18.8 percentage of participants
|
15.0 percentage of participants
|
25.0 percentage of participants
|
SECONDARY outcome
Timeframe: Weekly for 6 weeksPopulation: Safety data for 56 participants exposed to study treatment.
Percentage of participants with new onset or worsening compared to baseline of "Insomnia" rating on the SEC, by Treatment Group.
Outcome measures
| Measure |
1: Oxytocin/Placebo-galantamine
n=16 Participants
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
|
2: Galantamine/Placebo-oxytocin
n=20 Participants
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
|
3: Placebo-galantamine /Placebo-oxytocin
n=20 Participants
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
|
|---|---|---|---|
|
Side Effect Checklist (SEC) - Insomnia
|
18.8 percentage of participants
|
10.0 percentage of participants
|
5.0 percentage of participants
|
SECONDARY outcome
Timeframe: Weekly for 6 weeksPopulation: Safety data for 56 participants exposed to study treatment.
Percentage of participants with new onset or worsening compared to baseline of "Malaise" rating on the SEC, by Treatment Group.
Outcome measures
| Measure |
1: Oxytocin/Placebo-galantamine
n=16 Participants
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
|
2: Galantamine/Placebo-oxytocin
n=20 Participants
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
|
3: Placebo-galantamine /Placebo-oxytocin
n=20 Participants
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
|
|---|---|---|---|
|
Side Effect Checklist (SEC) - Malaise
|
18.8 percentage of participants
|
0.0 percentage of participants
|
10.0 percentage of participants
|
SECONDARY outcome
Timeframe: Weekly for 6 weeksPopulation: Safety data for 56 participants exposed to study treatment.
Percentage of participants with new onset or worsening compared to baseline of "Mucosal Ulceration" rating on the SEC, by Treatment Group.
Outcome measures
| Measure |
1: Oxytocin/Placebo-galantamine
n=16 Participants
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
|
2: Galantamine/Placebo-oxytocin
n=20 Participants
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
|
3: Placebo-galantamine /Placebo-oxytocin
n=20 Participants
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
|
|---|---|---|---|
|
Side Effect Checklist (SEC) - Mucosal Ulceration
|
6.3 percentage of participants
|
5.0 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Weekly for 6 weeksPopulation: Safety data for 56 participants exposed to study treatment minus 6 participants who had missing "nasal irritation" data.
Percentage of participants with new onset or worsening compared to baseline of "Nasal Irritation" rating on the SEC, by Treatment Group.
Outcome measures
| Measure |
1: Oxytocin/Placebo-galantamine
n=15 Participants
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
|
2: Galantamine/Placebo-oxytocin
n=18 Participants
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
|
3: Placebo-galantamine /Placebo-oxytocin
n=17 Participants
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
|
|---|---|---|---|
|
Side Effect Checklist (SEC) - Nasal Irritation
|
33.3 percentage of participants
|
16.7 percentage of participants
|
23.5 percentage of participants
|
SECONDARY outcome
Timeframe: Weekly for 6 weeksPopulation: Safety data for 56 participants exposed to study treatment.
Percentage of participants with new onset or worsening compared to baseline of "Nausea" rating on the SEC, by Treatment Group.
Outcome measures
| Measure |
1: Oxytocin/Placebo-galantamine
n=16 Participants
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
|
2: Galantamine/Placebo-oxytocin
n=20 Participants
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
|
3: Placebo-galantamine /Placebo-oxytocin
n=20 Participants
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
|
|---|---|---|---|
|
Side Effect Checklist (SEC) - Nausea
|
18.8 percentage of participants
|
15.0 percentage of participants
|
5.0 percentage of participants
|
SECONDARY outcome
Timeframe: Weekly for 6 weeksPopulation: Safety data for 56 participants exposed to study treatment.
Percentage of participants with new onset or worsening compared to baseline of "Rash" rating on the SEC, by Treatment Group.
Outcome measures
| Measure |
1: Oxytocin/Placebo-galantamine
n=16 Participants
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
|
2: Galantamine/Placebo-oxytocin
n=20 Participants
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
|
3: Placebo-galantamine /Placebo-oxytocin
n=20 Participants
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
|
|---|---|---|---|
|
Side Effect Checklist (SEC) - Rash
|
12.5 percentage of participants
|
10.0 percentage of participants
|
10.0 percentage of participants
|
SECONDARY outcome
Timeframe: Weekly for 6 weeksPopulation: Safety data for 56 participants exposed to study treatment.
Percentage of participants with new onset or worsening compared to baseline of "Restlessness" rating on the SEC, by Treatment Group.
Outcome measures
| Measure |
1: Oxytocin/Placebo-galantamine
n=16 Participants
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
|
2: Galantamine/Placebo-oxytocin
n=20 Participants
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
|
3: Placebo-galantamine /Placebo-oxytocin
n=20 Participants
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
|
|---|---|---|---|
|
Side Effect Checklist (SEC) - Restlessness
|
18.8 percentage of participants
|
10.0 percentage of participants
|
15.0 percentage of participants
|
SECONDARY outcome
Timeframe: Weekly for 6 weeksPopulation: Safety data for 56 participants exposed to study treatment.
Percentage of participants with new onset or worsening compared to baseline of "Sedation" rating on the SEC, by Treatment Group.
Outcome measures
| Measure |
1: Oxytocin/Placebo-galantamine
n=16 Participants
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
|
2: Galantamine/Placebo-oxytocin
n=20 Participants
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
|
3: Placebo-galantamine /Placebo-oxytocin
n=20 Participants
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
|
|---|---|---|---|
|
Side Effect Checklist (SEC) - Sedation
|
12.5 percentage of participants
|
15.0 percentage of participants
|
10.0 percentage of participants
|
SECONDARY outcome
Timeframe: Weekly for 6 weeksPopulation: Safety data for 56 participants exposed to study treatment.
Percentage of participants with new onset or worsening compared to baseline of "Sore Throat" rating on the SEC, by Treatment Group.
Outcome measures
| Measure |
1: Oxytocin/Placebo-galantamine
n=16 Participants
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
|
2: Galantamine/Placebo-oxytocin
n=20 Participants
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
|
3: Placebo-galantamine /Placebo-oxytocin
n=20 Participants
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
|
|---|---|---|---|
|
Side Effect Checklist (SEC) - Sore Throat
|
6.3 percentage of participants
|
10.0 percentage of participants
|
5.0 percentage of participants
|
SECONDARY outcome
Timeframe: Weekly for 6 weeksPopulation: Safety data for 56 participants exposed to study treatment.
Percentage of participants with new onset or worsening compared to baseline of "Stiffness" rating on the SEC, by Treatment Group.
Outcome measures
| Measure |
1: Oxytocin/Placebo-galantamine
n=16 Participants
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
|
2: Galantamine/Placebo-oxytocin
n=20 Participants
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
|
3: Placebo-galantamine /Placebo-oxytocin
n=20 Participants
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
|
|---|---|---|---|
|
Side Effect Checklist (SEC) - Stiffness
|
6.3 percentage of participants
|
10.0 percentage of participants
|
10.0 percentage of participants
|
SECONDARY outcome
Timeframe: Weekly for 6 weeksPopulation: Safety data for 56 participants exposed to study treatment.
Percentage of participants with new onset or worsening compared to baseline of "Tinnitus" rating on the SEC, by Treatment Group.
Outcome measures
| Measure |
1: Oxytocin/Placebo-galantamine
n=16 Participants
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
|
2: Galantamine/Placebo-oxytocin
n=20 Participants
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
|
3: Placebo-galantamine /Placebo-oxytocin
n=19 Participants
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
|
|---|---|---|---|
|
Side Effect Checklist (SEC) - Tinnitus
|
0.0 percentage of participants
|
0.0 percentage of participants
|
10.5 percentage of participants
|
SECONDARY outcome
Timeframe: Weekly for 6 weeksPopulation: Safety data for 56 participants exposed to study treatment.
Percentage of participants with new onset or worsening compared to baseline of "Tremor" rating on the SEC, by Treatment Group.
Outcome measures
| Measure |
1: Oxytocin/Placebo-galantamine
n=16 Participants
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
|
2: Galantamine/Placebo-oxytocin
n=20 Participants
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
|
3: Placebo-galantamine /Placebo-oxytocin
n=20 Participants
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
|
|---|---|---|---|
|
Side Effect Checklist (SEC) - Tremor
|
6.3 percentage of participants
|
15.0 percentage of participants
|
10.0 percentage of participants
|
SECONDARY outcome
Timeframe: Weekly for 6 weeksPopulation: Safety data for 56 participants exposed to study treatment.
Percentage of participants with new onset or worsening compared to baseline of "Urticaria" rating on the SEC, by Treatment Group.
Outcome measures
| Measure |
1: Oxytocin/Placebo-galantamine
n=16 Participants
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
|
2: Galantamine/Placebo-oxytocin
n=20 Participants
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
|
3: Placebo-galantamine /Placebo-oxytocin
n=20 Participants
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
|
|---|---|---|---|
|
Side Effect Checklist (SEC) - Urticaria
|
18.8 percentage of participants
|
15.0 percentage of participants
|
15.0 percentage of participants
|
SECONDARY outcome
Timeframe: Weekly for 6 weeksPopulation: Female participants
Percentage of participants with new onset or worsening compared to baseline of "Uterine Contractions" rating on the SEC, by Treatment Group.
Outcome measures
| Measure |
1: Oxytocin/Placebo-galantamine
n=2 Participants
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
|
2: Galantamine/Placebo-oxytocin
n=6 Participants
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
|
3: Placebo-galantamine /Placebo-oxytocin
n=3 Participants
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
|
|---|---|---|---|
|
Side Effect Checklist (SEC) - Uterine Contractions
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Weekly for 6 weeksPopulation: Safety data for 56 participants exposed to study treatment.
Percentage of participants with new onset or worsening compared to baseline of "Vomiting" rating on the SEC, by Treatment Group.
Outcome measures
| Measure |
1: Oxytocin/Placebo-galantamine
n=16 Participants
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
|
2: Galantamine/Placebo-oxytocin
n=20 Participants
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
|
3: Placebo-galantamine /Placebo-oxytocin
n=20 Participants
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
|
|---|---|---|---|
|
Side Effect Checklist (SEC) - Vomiting
|
12.5 percentage of participants
|
5.0 percentage of participants
|
10.0 percentage of participants
|
SECONDARY outcome
Timeframe: Weekly for 6 weeksPopulation: Safety data for 56 participants exposed to study treatment.
Percentage of participants with new onset or worsening compared to baseline of "Weight Loss" rating on the SEC, by Treatment Group.
Outcome measures
| Measure |
1: Oxytocin/Placebo-galantamine
n=16 Participants
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
|
2: Galantamine/Placebo-oxytocin
n=20 Participants
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
|
3: Placebo-galantamine /Placebo-oxytocin
n=20 Participants
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
|
|---|---|---|---|
|
Side Effect Checklist (SEC) - Weight Loss
|
18.8 percentage of participants
|
5.0 percentage of participants
|
25.0 percentage of participants
|
SECONDARY outcome
Timeframe: Weekly for 6 weeksPopulation: Safety data for 56 participants exposed to study treatment minus 6 participants with missing "wheezing" data.
Percentage of participants with new onset or worsening compared to baseline of "Wheezing" rating on the SEC, by Treatment Group.
Outcome measures
| Measure |
1: Oxytocin/Placebo-galantamine
n=15 Participants
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
|
2: Galantamine/Placebo-oxytocin
n=18 Participants
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
|
3: Placebo-galantamine /Placebo-oxytocin
n=17 Participants
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
|
|---|---|---|---|
|
Side Effect Checklist (SEC) - Wheezing
|
13.3 percentage of participants
|
5.6 percentage of participants
|
11.8 percentage of participants
|
SECONDARY outcome
Timeframe: Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).Population: Cognitive data was collected at baseline and week 6, so only those participants who got to week 6 appear in cognitive outcome analyses.
MCCB Composite Score by Week ranging from -10-100 with a higher score indicating a better outcome.
Outcome measures
| Measure |
1: Oxytocin/Placebo-galantamine
n=15 Participants
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
|
2: Galantamine/Placebo-oxytocin
n=16 Participants
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
|
3: Placebo-galantamine /Placebo-oxytocin
n=15 Participants
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
|
|---|---|---|---|
|
Neurocognitive Assessment Battery (MCCB) - Composite Score
Change
|
2.3 units on a scale
Standard Deviation 3.9
|
1.7 units on a scale
Standard Deviation 4.0
|
0.7 units on a scale
Standard Deviation 8.0
|
|
Neurocognitive Assessment Battery (MCCB) - Composite Score
Treatment Week 0
|
25.9 units on a scale
Standard Deviation 13.0
|
24.5 units on a scale
Standard Deviation 9.7
|
28.2 units on a scale
Standard Deviation 9.6
|
|
Neurocognitive Assessment Battery (MCCB) - Composite Score
Treatment Week 6
|
28.2 units on a scale
Standard Deviation 14.1
|
26.2 units on a scale
Standard Deviation 11.1
|
28.9 units on a scale
Standard Deviation 11.8
|
SECONDARY outcome
Timeframe: Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).Population: Cognitive data was collected at baseline and week 6, so only those participants who got to week 6 appear in cognitive outcome analyses.
MCCB Attention Vigilance domain score by week calculated from the Continuous Performance Test, Identical Pairs version. The domain score scale is 20-80, with higher scores indicating a better outcome. .
Outcome measures
| Measure |
1: Oxytocin/Placebo-galantamine
n=15 Participants
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
|
2: Galantamine/Placebo-oxytocin
n=17 Participants
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
|
3: Placebo-galantamine /Placebo-oxytocin
n=17 Participants
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
|
|---|---|---|---|
|
Neurocognitive Assessment Battery (MCCB) - Attention Vigilance
Treatment Week 0
|
36.9 units on a scale
Standard Deviation 8.8
|
33.5 units on a scale
Standard Deviation 14.5
|
37.2 units on a scale
Standard Deviation 10.9
|
|
Neurocognitive Assessment Battery (MCCB) - Attention Vigilance
Treatment Week 6
|
39.5 units on a scale
Standard Deviation 11.3
|
34.5 units on a scale
Standard Deviation 13.6
|
35.1 units on a scale
Standard Deviation 12.7
|
|
Neurocognitive Assessment Battery (MCCB) - Attention Vigilance
Change
|
2.6 units on a scale
Standard Deviation 5.8
|
1.1 units on a scale
Standard Deviation 6.9
|
-2.1 units on a scale
Standard Deviation 6.9
|
SECONDARY outcome
Timeframe: Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).Population: Cognitive data was collected at baseline and week 6, so only those participants who got to week 6 appear in cognitive outcome analyses.
MCCB Processing Speed domain score by week calculated from the Trail Making Test- Part A, Brief Assessment of Cognition in Schizophrenia- symbol coding subtest, and the Category fluency test- animal naming. The domain score scale is 20-80, with higher scores indicating a better outcome.
Outcome measures
| Measure |
1: Oxytocin/Placebo-galantamine
n=15 Participants
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
|
2: Galantamine/Placebo-oxytocin
n=18 Participants
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
|
3: Placebo-galantamine /Placebo-oxytocin
n=17 Participants
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
|
|---|---|---|---|
|
Neurocognitive Assessment Battery (MCCB) - Processing Speed
Treatment Week 0
|
33.5 units on a scale
Standard Deviation 13.1
|
31.9 units on a scale
Standard Deviation 11.7
|
34.0 units on a scale
Standard Deviation 10.9
|
|
Neurocognitive Assessment Battery (MCCB) - Processing Speed
Treatment Week 6
|
34.2 units on a scale
Standard Deviation 11.6
|
35.4 units on a scale
Standard Deviation 8.6
|
35.6 units on a scale
Standard Deviation 12.7
|
|
Neurocognitive Assessment Battery (MCCB) - Processing Speed
Change
|
0.7 units on a scale
Standard Deviation 4.3
|
3.5 units on a scale
Standard Deviation 5.6
|
1.6 units on a scale
Standard Deviation 7.3
|
SECONDARY outcome
Timeframe: Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).Population: Cognitive data was collected at baseline and week 6, so only those participants who got to week 6 appear in cognitive outcome analyses.
MCCB Reasoning/Problem Solving domain score by week calculated from the Neuropsychological Assessment Battery- mazes subtest. The domain score scale is 20-80, with higher scores indicating a better outcome.
Outcome measures
| Measure |
1: Oxytocin/Placebo-galantamine
n=15 Participants
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
|
2: Galantamine/Placebo-oxytocin
n=18 Participants
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
|
3: Placebo-galantamine /Placebo-oxytocin
n=17 Participants
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
|
|---|---|---|---|
|
Neurocognitive Assessment Battery (MCCB) - Reasoning/Problem Solving
Treatment Week 0
|
39.7 units on a scale
Standard Deviation 10.8
|
39.3 units on a scale
Standard Deviation 6.8
|
41.4 units on a scale
Standard Deviation 8.4
|
|
Neurocognitive Assessment Battery (MCCB) - Reasoning/Problem Solving
Treatment Week 6
|
40.7 units on a scale
Standard Deviation 9.4
|
42.9 units on a scale
Standard Deviation 8.3
|
41.7 units on a scale
Standard Deviation 9.7
|
|
Neurocognitive Assessment Battery (MCCB) - Reasoning/Problem Solving
Change
|
1.0 units on a scale
Standard Deviation 8.1
|
3.7 units on a scale
Standard Deviation 5.1
|
0.3 units on a scale
Standard Deviation 10.1
|
SECONDARY outcome
Timeframe: Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).Population: Cognitive data was collected at baseline and week 6, so only those participants who got to week 6 appear in cognitive outcome analyses.
MCCB Social Cognition domain score by week calculated from the Mayer-Salovey-Caruso Emotional Intelligence Test- managing emotions branch. The domain score scale is 20-80, with higher scores indicating a better outcome.
Outcome measures
| Measure |
1: Oxytocin/Placebo-galantamine
n=15 Participants
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
|
2: Galantamine/Placebo-oxytocin
n=17 Participants
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
|
3: Placebo-galantamine /Placebo-oxytocin
n=15 Participants
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
|
|---|---|---|---|
|
Neurocognitive Assessment Battery (MCCB) - Social Cognition
Treatment Week 0
|
31.7 units on a scale
Standard Deviation 9.7
|
32.8 units on a scale
Standard Deviation 10.4
|
30.4 units on a scale
Standard Deviation 10.1
|
|
Neurocognitive Assessment Battery (MCCB) - Social Cognition
Treatment Week 6
|
32.5 units on a scale
Standard Deviation 13.0
|
29.6 units on a scale
Standard Deviation 10.0
|
32.8 units on a scale
Standard Deviation 10.9
|
|
Neurocognitive Assessment Battery (MCCB) - Social Cognition
Change
|
0.8 units on a scale
Standard Deviation 7.6
|
-3.2 units on a scale
Standard Deviation 4.6
|
2.4 units on a scale
Standard Deviation 7.3
|
SECONDARY outcome
Timeframe: Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).Population: Cognitive data was collected at baseline and week 6, so only those participants who got to week 6 appear in cognitive outcome analyses.
MCCB Verbal Learning domain score by week calculated from the Hopkins Verbal Learning Test-Revised, immediate recall (three learning trials only). The domain score scale is 20-80, with higher scores indicating a better outcome.
Outcome measures
| Measure |
1: Oxytocin/Placebo-galantamine
n=15 Participants
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
|
2: Galantamine/Placebo-oxytocin
n=18 Participants
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
|
3: Placebo-galantamine /Placebo-oxytocin
n=17 Participants
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
|
|---|---|---|---|
|
Neurocognitive Assessment Battery (MCCB) - Verbal Learning
Treatment Week 0
|
36.3 units on a scale
Standard Deviation 8.5
|
33.4 units on a scale
Standard Deviation 5.0
|
36.5 units on a scale
Standard Deviation 8.2
|
|
Neurocognitive Assessment Battery (MCCB) - Verbal Learning
Treatment Week 6
|
38.7 units on a scale
Standard Deviation 9.9
|
35.8 units on a scale
Standard Deviation 7.7
|
36.4 units on a scale
Standard Deviation 4.4
|
|
Neurocognitive Assessment Battery (MCCB) - Verbal Learning
Change
|
2.5 units on a scale
Standard Deviation 5.4
|
2.4 units on a scale
Standard Deviation 5.8
|
-0.1 units on a scale
Standard Deviation 7.6
|
SECONDARY outcome
Timeframe: Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).Population: Cognitive data was collected at baseline and week 6, so only those participants who got to week 6 appear in cognitive outcome analyses.
MCCB Visual Learning domain score by week calculated from the Brief Visuospatial Memory Test-Revised. The domain score scale is 20-80, with higher scores indicating a better outcome.
Outcome measures
| Measure |
1: Oxytocin/Placebo-galantamine
n=15 Participants
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
|
2: Galantamine/Placebo-oxytocin
n=18 Participants
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
|
3: Placebo-galantamine /Placebo-oxytocin
n=17 Participants
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
|
|---|---|---|---|
|
Neurocognitive Assessment Battery (MCCB) - Visual Learning
Treatment Week 0
|
33.8 units on a scale
Standard Deviation 14.3
|
37.2 units on a scale
Standard Deviation 10.8
|
35.1 units on a scale
Standard Deviation 9.4
|
|
Neurocognitive Assessment Battery (MCCB) - Visual Learning
Treatment Week 6
|
36.2 units on a scale
Standard Deviation 16.6
|
33.7 units on a scale
Standard Deviation 10.0
|
34.2 units on a scale
Standard Deviation 10.3
|
|
Neurocognitive Assessment Battery (MCCB) - Visual Learning
Change
|
2.4 units on a scale
Standard Deviation 6.2
|
-3.4 units on a scale
Standard Deviation 8.3
|
-0.9 units on a scale
Standard Deviation 7.2
|
SECONDARY outcome
Timeframe: Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).Population: Cognitive data was collected at baseline and week 6, so only those participants who got to week 6 appear in cognitive outcome analyses.
MCCB Working Memory domain score by week calculated from the Wechsler Memory Scale, 3rd ed., spatial span subtest. The domain score scale is 20-80, with higher scores indicating a better outcome.
Outcome measures
| Measure |
1: Oxytocin/Placebo-galantamine
n=15 Participants
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
|
2: Galantamine/Placebo-oxytocin
n=18 Participants
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
|
3: Placebo-galantamine /Placebo-oxytocin
n=17 Participants
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
|
|---|---|---|---|
|
Neurocognitive Assessment Battery (MCCB) - Working Memory
Treatment Week 0
|
34.7 units on a scale
Standard Deviation 10.7
|
33.7 units on a scale
Standard Deviation 9.6
|
35.3 units on a scale
Standard Deviation 11.0
|
|
Neurocognitive Assessment Battery (MCCB) - Working Memory
Treatment Week 6
|
34.8 units on a scale
Standard Deviation 11.1
|
34.7 units on a scale
Standard Deviation 10.4
|
38.1 units on a scale
Standard Deviation 11.7
|
|
Neurocognitive Assessment Battery (MCCB) - Working Memory
Change
|
0.1 units on a scale
Standard Deviation 6.5
|
0.9 units on a scale
Standard Deviation 7.7
|
2.8 units on a scale
Standard Deviation 6.4
|
SECONDARY outcome
Timeframe: Treatment Week 0 and Week 6Population: Role play data was collected at baseline and week 6, so only those participants who completed the role play at week 6 appear in these outcome analyses.
Participant reported responses after Brief Role Play rating how they felt during the role plays. Participants rated 12 negative affect items on a scale of 1-5, with 1 being "very slightly or not at all" and 5 being "extremely". The minimum score for this measure is 12 and the maximum score is 60. Higher scores indicate a higher rate of negative affect during the role plays.
Outcome measures
| Measure |
1: Oxytocin/Placebo-galantamine
n=15 Participants
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
|
2: Galantamine/Placebo-oxytocin
n=17 Participants
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
|
3: Placebo-galantamine /Placebo-oxytocin
n=17 Participants
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
|
|---|---|---|---|
|
Positive and Negative Affect Schedule (PANAS) - Negative
Change from Week 0 at Week 6
|
-1.7 units on a scale
Standard Deviation 5.7
|
-0.2 units on a scale
Standard Deviation 6.8
|
-1.3 units on a scale
Standard Deviation 5.6
|
|
Positive and Negative Affect Schedule (PANAS) - Negative
Treatment Week 0
|
20.5 units on a scale
Standard Deviation 7.8
|
18.2 units on a scale
Standard Deviation 7.0
|
20.2 units on a scale
Standard Deviation 8.6
|
|
Positive and Negative Affect Schedule (PANAS) - Negative
Treatment Week 6
|
18.8 units on a scale
Standard Deviation 7.7
|
18.0 units on a scale
Standard Deviation 5.6
|
18.9 units on a scale
Standard Deviation 8.2
|
SECONDARY outcome
Timeframe: Treatment Week 0 and Week 6Population: Role play data was collected at baseline and week 6, so only those participants who completed the role play at week 6 appear in these outcome analyses.
Participant reported responses after Brief Role Play rating how they felt during the role plays. Participants rated 12 positive affect items on a scale of 1-5, with 1 being "very slightly or not at all" and 5 being "extremely". The minimum score for this measure is 12 and the maximum score is 60. Higher scores indicate a higher rate of positive affect during the role plays.
Outcome measures
| Measure |
1: Oxytocin/Placebo-galantamine
n=15 Participants
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
|
2: Galantamine/Placebo-oxytocin
n=17 Participants
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
|
3: Placebo-galantamine /Placebo-oxytocin
n=17 Participants
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
|
|---|---|---|---|
|
Positive and Negative Affect Schedule (PANAS) - Positive
Treatment Week 0
|
38.1 units on a scale
Standard Deviation 8.6
|
37.0 units on a scale
Standard Deviation 12.3
|
42.5 units on a scale
Standard Deviation 8.9
|
|
Positive and Negative Affect Schedule (PANAS) - Positive
Treatment Week 6
|
38.5 units on a scale
Standard Deviation 12.8
|
39.5 units on a scale
Standard Deviation 12.3
|
40.8 units on a scale
Standard Deviation 9.6
|
|
Positive and Negative Affect Schedule (PANAS) - Positive
Change from Week 0 at Week 6
|
0.4 units on a scale
Standard Deviation 10.8
|
2.5 units on a scale
Standard Deviation 11.4
|
-1.6 units on a scale
Standard Deviation 11.2
|
SECONDARY outcome
Timeframe: Treatment Week 0 and Week 6Population: Role play data was collected at baseline and week 6, so only those participants who completed the role play at week 6 appear in these outcome analyses.
Participant reported responses after Brief Role Play. The Reactions to Partner item was calculated by totaling responses to 7 scales. Each scale score ranges from 1-5, which 1 being "completely agree" and 5 being "completely disagree". The minimum score for this measure is 7 and the maximum score is 35. Higher responses indicate a more negative reaction to their role play partner.
Outcome measures
| Measure |
1: Oxytocin/Placebo-galantamine
n=15 Participants
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
|
2: Galantamine/Placebo-oxytocin
n=17 Participants
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
|
3: Placebo-galantamine /Placebo-oxytocin
n=17 Participants
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
|
|---|---|---|---|
|
Reactions to Partner
Treatment Week 0
|
13.7 units on a scale
Standard Deviation 4.2
|
14.4 units on a scale
Standard Deviation 5.6
|
12.5 units on a scale
Standard Deviation 4.2
|
|
Reactions to Partner
Treatment Week 6
|
13.7 units on a scale
Standard Deviation 3.1
|
13.9 units on a scale
Standard Deviation 3.7
|
12.5 units on a scale
Standard Deviation 3.5
|
|
Reactions to Partner
Change from Week 0 at Week 6
|
0.0 units on a scale
Standard Deviation 3.5
|
-0.4 units on a scale
Standard Deviation 4.0
|
0.0 units on a scale
Standard Deviation 3.7
|
SECONDARY outcome
Timeframe: Treatment Week 0 and Week 6Population: Role play data was collected at baseline and week 6, so only those participants who completed the role play at week 6 appear in these outcome analyses.
Participant reported responses after Brief Role Play. The Willingness to Interact item calculated by totaling scores from items 1-6. Each score ranges from 1-5, with 1 being "definitely willing" and 5 being "definitely unwilling". The minimum score for this measure is 6 and the maximum score is 30. Lower scores indicate more willingness to interact with their role play partner again in the future.
Outcome measures
| Measure |
1: Oxytocin/Placebo-galantamine
n=15 Participants
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
|
2: Galantamine/Placebo-oxytocin
n=17 Participants
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
|
3: Placebo-galantamine /Placebo-oxytocin
n=17 Participants
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
|
|---|---|---|---|
|
Willingness to Interact
Treatment Week 0
|
23.67 units on a scale
Standard Deviation 4.13
|
23.18 units on a scale
Standard Deviation 4.22
|
24.41 units on a scale
Standard Deviation 4.33
|
|
Willingness to Interact
Treatment Week 6
|
24.47 units on a scale
Standard Deviation 3.31
|
24.24 units on a scale
Standard Deviation 4.34
|
25.00 units on a scale
Standard Deviation 4.29
|
|
Willingness to Interact
Change from Week 0 at Week 6
|
0.80 units on a scale
Standard Deviation 3.82
|
1.06 units on a scale
Standard Deviation 3.60
|
0.59 units on a scale
Standard Deviation 4.02
|
Adverse Events
1: Oxytocin
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
2: Galantamine
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
3: Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
1: Oxytocin
n=17 participants at risk
Oxytocin: 24 IU oxytocin or placebo in a total of 6 puffs (3 puffs per nostril)daily for 6 weeks
|
2: Galantamine
n=20 participants at risk
Galantamine or placebo Galantamine: Galantamine will be dispensed as follows: 4 mg bid x 7 days; 8mg bid x 7days, then 12 mg bid for the last 4 weeks.
|
3: Placebo
n=21 participants at risk
Placebo: placebo-Galantamine 1 capsules twice a day and placebo-oxytocin 3 puffs in each nostril once a day.
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
hospitalization due to unrelated pneumonia
|
0.00%
0/17
|
5.0%
1/20
|
0.00%
0/21
|
Other adverse events
| Measure |
1: Oxytocin
n=17 participants at risk
Oxytocin: 24 IU oxytocin or placebo in a total of 6 puffs (3 puffs per nostril)daily for 6 weeks
|
2: Galantamine
n=20 participants at risk
Galantamine or placebo Galantamine: Galantamine will be dispensed as follows: 4 mg bid x 7 days; 8mg bid x 7days, then 12 mg bid for the last 4 weeks.
|
3: Placebo
n=21 participants at risk
Placebo: placebo-Galantamine 1 capsules twice a day and placebo-oxytocin 3 puffs in each nostril once a day.
|
|---|---|---|---|
|
Renal and urinary disorders
Enuresis
|
23.5%
4/17
|
5.0%
1/20
|
0.00%
0/21
|
Additional Information
William Carpenter, Jr.
Maryland Psychiatric Research Center
Phone: 410-402-7101
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place