Trial Outcomes & Findings for D-cycloserine Augmentation of Cognitive Remediation in Schizophrenia (NCT NCT00963924)
NCT ID: NCT00963924
Last Updated: 2018-02-06
Results Overview
Change of a composite score from baseline to week 8 on the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS). The MATRICS consists of 10 cognitive tasks that are used to calculate scores in 7 cognitive domains: speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The raw scores on each cognitive task are transformed on a normative scale into t-scores, and then these scores are combined to calculate the domain scores. The composite score is calculated by averaging all domain t-scores to come up with one overall cognitive composite t-score. For all scores on the assessment, the higher the score the better the performance on the task.
COMPLETED
NA
54 participants
Baseline vs. Week 8
2018-02-06
Participant Flow
54 patients were assessed for eligibility; however, 14 were excluded (11 were ineligible, and 3 withdrew consent). 40 participants were randomized, however 4 were excluded (1 serious adverse event, 2 withdrew consent, and 1 was lost to follow up), therefore 36 entered the treatment phase.
Participant milestones
| Measure |
D-cycloserine
Participants will receive D-cycloserine weekly, one hour before the first cognitive remediation session of the week, for eight weeks.
|
Placebo
Participants will receive placebo weekly, one hour before the first cognitive remediation session of the week, for eight weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
18
|
|
Overall Study
COMPLETED
|
17
|
15
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
| Measure |
D-cycloserine
Participants will receive D-cycloserine weekly, one hour before the first cognitive remediation session of the week, for eight weeks.
|
Placebo
Participants will receive placebo weekly, one hour before the first cognitive remediation session of the week, for eight weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Changed antipsychotic
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
D-cycloserine Augmentation of Cognitive Remediation in Schizophrenia
Baseline characteristics by cohort
| Measure |
D-cycloserine
n=18 Participants
Participants will receive D-cycloserine weekly, one hour before the first cognitive remediation session of the week, for eight weeks.
|
Placebo
n=18 Participants
Participants will receive placebo weekly, one hour before the first cognitive remediation session of the week, for eight weeks.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
48.8 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
46.2 years
STANDARD_DEVIATION 13.3 • n=7 Participants
|
47.5 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=5 Participants
|
18 participants
n=7 Participants
|
36 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline vs. Week 8Population: 18 participants in each arm had baseline values available for analysis. 17 in the D-cycloserine arm and 15 in the placebo arm had week 8 values available for analysis.
Change of a composite score from baseline to week 8 on the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS). The MATRICS consists of 10 cognitive tasks that are used to calculate scores in 7 cognitive domains: speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The raw scores on each cognitive task are transformed on a normative scale into t-scores, and then these scores are combined to calculate the domain scores. The composite score is calculated by averaging all domain t-scores to come up with one overall cognitive composite t-score. For all scores on the assessment, the higher the score the better the performance on the task.
Outcome measures
| Measure |
D-cycloserine
n=18 Participants
Participants will receive D-cycloserine weekly, one hour before the first cognitive remediation session of the week, for eight weeks.
|
Placebo
n=18 Participants
Participants will receive placebo weekly, one hour before the first cognitive remediation session of the week, for eight weeks.
|
|---|---|---|
|
Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS)
Baseline
|
32.1 t-scores
Standard Deviation 13.4
|
33.0 t-scores
Standard Deviation 13.8
|
|
Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS)
Week 8
|
32.24 t-scores
Standard Deviation 13.53
|
33.8 t-scores
Standard Deviation 14.50
|
PRIMARY outcome
Timeframe: Baseline vs. Week 8Population: 18 participants in each arm had baseline values available for analysis. 17 in the D-cycloserine arm and 15 in the placebo arm had week 8 values available for analysis.
The total scores from baseline and week 8 on the scale for the assessment of negative symptoms (SANS) total score. Total SANS scores range from 0-100. The SANS is comprised of 5 subscores: Affective Flattening or Blunting (score range 0-35), Alogia (score range 0-20), Avolition-Apathy (score range 0-15), Anhedonia-Asociality (score range 0-20), and Attention (0-10). For each scale, the higher the score the more prominent the negative symptoms were. The total score was computed by adding all the sub-scale total scores. Scores are reported for baseline and week 8.
Outcome measures
| Measure |
D-cycloserine
n=18 Participants
Participants will receive D-cycloserine weekly, one hour before the first cognitive remediation session of the week, for eight weeks.
|
Placebo
n=18 Participants
Participants will receive placebo weekly, one hour before the first cognitive remediation session of the week, for eight weeks.
|
|---|---|---|
|
Scale for Assessment of Negative Symptoms (SANS)
Baseline
|
24.6 units on a scale
Standard Deviation 13.5
|
25.8 units on a scale
Standard Deviation 10.7
|
|
Scale for Assessment of Negative Symptoms (SANS)
Week 8
|
22.41 units on a scale
Standard Deviation 10.28
|
24.67 units on a scale
Standard Deviation 10.42
|
PRIMARY outcome
Timeframe: Baseline vs. Week 8Population: 18 participants in each arm had baseline values available for analysis. 17 in the D-cycloserine arm and 15 in the placebo arm had week 8 values available for analysis.
The auditory discrimination task involved trials in which the subject differentiated between rapidly-presented frequency-modulated sweeps separated by a short interstimulus interval (ISI). In this task, sustained successful performance is more difficult with shorter stimulus presentations and ISIs (which were equal within a trial). Thus, our dependent measure was the shortest stimulus duration/ISI, in ms, for trials in which subjects were able to perform the task at 85% accuracy, referred to as ISI for simplicity. The shorter the score the better the performance on the task. Scores are reported for baseline and week 8.
Outcome measures
| Measure |
D-cycloserine
n=18 Participants
Participants will receive D-cycloserine weekly, one hour before the first cognitive remediation session of the week, for eight weeks.
|
Placebo
n=18 Participants
Participants will receive placebo weekly, one hour before the first cognitive remediation session of the week, for eight weeks.
|
|---|---|---|
|
Auditory Discrimination Task: Interstimulus Interval (ISI)
Baseline
|
163.5 milliseconds
Standard Deviation 86.5
|
124.8 milliseconds
Standard Deviation 93.0
|
|
Auditory Discrimination Task: Interstimulus Interval (ISI)
Week 8
|
91.7 milliseconds
Standard Deviation 65.4
|
127.9 milliseconds
Standard Deviation 115.6
|
SECONDARY outcome
Timeframe: BaselineThe baseline score on the positive symptom sub-scale of the Positive and Negative Syndrome Scale (PANSS). Total PANSS positive symptom sub-scale scores range from 7-49. The PANSS positive symptom sub-scale is comprised of 7 items rated on a scale of 1-7: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. A score of one on each item 1 absent, 2 is minimal, 3 is mild, 4 is moderate, 5 is moderately severe, 6 is severe, and 7 is extreme. The total score was computed by adding all the items on the sub-scale together. The higher a score the more prominent a positive symptom is.
Outcome measures
| Measure |
D-cycloserine
n=18 Participants
Participants will receive D-cycloserine weekly, one hour before the first cognitive remediation session of the week, for eight weeks.
|
Placebo
n=18 Participants
Participants will receive placebo weekly, one hour before the first cognitive remediation session of the week, for eight weeks.
|
|---|---|---|
|
Positive and Negative Syndrome Scale (PANSS)
|
61.8 units on a scale
Standard Deviation 11.4
|
64.1 units on a scale
Standard Deviation 15.5
|
SECONDARY outcome
Timeframe: BaselineThe Global Assessment of Functioning Scale (GAS) measured at baseline. This scale measures social, occupational, and psychological functioning, on a scale of 0-100. The higher the score, the greater a participant's functioning level.
Outcome measures
| Measure |
D-cycloserine
n=18 Participants
Participants will receive D-cycloserine weekly, one hour before the first cognitive remediation session of the week, for eight weeks.
|
Placebo
n=18 Participants
Participants will receive placebo weekly, one hour before the first cognitive remediation session of the week, for eight weeks.
|
|---|---|---|
|
Global Assessment of Functioning Scale (GAS)
|
53.7 units on a scale
Standard Deviation 6.5
|
50.8 units on a scale
Standard Deviation 11.2
|
SECONDARY outcome
Timeframe: BaselineBaseline scores of the Heinrich Quality of Life Scale, a 21 item scale designed and validated to measure intrapsychic foundations, interpersonal relations, instrumental role, and common objects and activities in patients diagnosed with Schizophrenia. Patients are rated on each of the 21 items on a scale of 0-6. Total scores are computed by adding up the scores of each individual item, with a total score ranging from 0-126. Higher scores reflect higher functioning.
Outcome measures
| Measure |
D-cycloserine
n=18 Participants
Participants will receive D-cycloserine weekly, one hour before the first cognitive remediation session of the week, for eight weeks.
|
Placebo
n=18 Participants
Participants will receive placebo weekly, one hour before the first cognitive remediation session of the week, for eight weeks.
|
|---|---|---|
|
Heinrich Quality of Life Scale (QoL)
|
71.8 units on a scale
Standard Deviation 18.5
|
71.4 units on a scale
Standard Deviation 15.6
|
SECONDARY outcome
Timeframe: BaselineBaseline scores on the Calgary Depression Scale for Schizophrenia (CDSS). Total CDSS scores range from 0-27. The assessment is comprised of 9 questions covering the topics of Depression, Hopelessness, Self Depreciation, Guilty Ideas of Reference, Pathological Guilt, Morning Depression, Early Wakening, Suicide, Observed Depression. Each item is scored on a scale from 0-3 (0 = absent, 1 = mild, 2 = moderate, 3 = severe). The total score is computed by adding up the individual scores of each item. The higher the score, the more prominent the symptoms of depression are for the participant.
Outcome measures
| Measure |
D-cycloserine
n=18 Participants
Participants will receive D-cycloserine weekly, one hour before the first cognitive remediation session of the week, for eight weeks.
|
Placebo
n=18 Participants
Participants will receive placebo weekly, one hour before the first cognitive remediation session of the week, for eight weeks.
|
|---|---|---|
|
Calgary Depression Scale for Schizophrenia (CDSS)
|
2.8 units on a scale
Standard Deviation 3.1
|
3.4 units on a scale
Standard Deviation 3.1
|
SECONDARY outcome
Timeframe: Weeks 0 and 8, and Month 6 after cognitive remediation completionPopulation: 18 participants in each arm had baseline data available for analysis. At week 8, 17 participants in the D-cycloserine group and 15 in the placebo group had data available. At month 6, 6 participants in the D-cycloserine group and 4 in the placebo group had data available.
Considering you total clinical experience with this patient population, how mentally ill is the patient at this time? 1=Normal, not at all, 2=Borderline mentally ill, 3=Mildy ill, 4=Moderately ill, 5=Markedly ill, 6=Severely ill, 7=Among the most extremely ill patients; a higher score indicates worse outcome
Outcome measures
| Measure |
D-cycloserine
n=18 Participants
Participants will receive D-cycloserine weekly, one hour before the first cognitive remediation session of the week, for eight weeks.
|
Placebo
n=18 Participants
Participants will receive placebo weekly, one hour before the first cognitive remediation session of the week, for eight weeks.
|
|---|---|---|
|
Clinical Global Impression (CGI)
Baseline
|
3.78 units on a scale
Standard Deviation 0.55
|
3.78 units on a scale
Standard Deviation 0.73
|
|
Clinical Global Impression (CGI)
Week 8
|
3.65 units on a scale
Standard Deviation 0.61
|
3.73 units on a scale
Standard Deviation 0.70
|
|
Clinical Global Impression (CGI)
Month 6
|
4.00 units on a scale
Standard Deviation 0.89
|
3.25 units on a scale
Standard Deviation 0.50
|
SECONDARY outcome
Timeframe: Weeks 0 - 8, and Month 6 after cognitive remediation completionPopulation: 18 participants in each arm had baseline data available for analysis. At week 8, 17 participants in the D-cycloserine group and 15 in the placebo group had data available. At month 6, 6 participants in the D-cycloserine group and 4 in the placebo group had data available.
Each side effect is entered as either yes or no for having had any severity of the side effect at each visit.
Outcome measures
| Measure |
D-cycloserine
n=18 Participants
Participants will receive D-cycloserine weekly, one hour before the first cognitive remediation session of the week, for eight weeks.
|
Placebo
n=18 Participants
Participants will receive placebo weekly, one hour before the first cognitive remediation session of the week, for eight weeks.
|
|---|---|---|
|
Side Effects Checklist (SEC)
Baseline : Bruising easily · Yes
|
1 Participants
|
0 Participants
|
|
Side Effects Checklist (SEC)
Baseline : Bruising easily · No
|
17 Participants
|
18 Participants
|
|
Side Effects Checklist (SEC)
Baseline : Rash · Yes
|
0 Participants
|
3 Participants
|
|
Side Effects Checklist (SEC)
Baseline : Rash · No
|
18 Participants
|
15 Participants
|
|
Side Effects Checklist (SEC)
Baseline : Urticaria (Hives, Itching) · Yes
|
1 Participants
|
4 Participants
|
|
Side Effects Checklist (SEC)
Baseline : Urticaria (Hives, Itching) · No
|
17 Participants
|
14 Participants
|
|
Side Effects Checklist (SEC)
Baseline : Blurred Vision · Yes
|
0 Participants
|
2 Participants
|
|
Side Effects Checklist (SEC)
Baseline : Blurred Vision · No
|
18 Participants
|
16 Participants
|
|
Side Effects Checklist (SEC)
Baseline : Sedation/Drowsiness · Yes
|
4 Participants
|
7 Participants
|
|
Side Effects Checklist (SEC)
Baseline : Sedation/Drowsiness · No
|
14 Participants
|
11 Participants
|
|
Side Effects Checklist (SEC)
Baseline : Restlessness · Yes
|
6 Participants
|
6 Participants
|
|
Side Effects Checklist (SEC)
Baseline : Restlessness · No
|
12 Participants
|
12 Participants
|
|
Side Effects Checklist (SEC)
Baseline : Insomnia · Yes
|
3 Participants
|
6 Participants
|
|
Side Effects Checklist (SEC)
Baseline : Insomnia · No
|
15 Participants
|
12 Participants
|
|
Side Effects Checklist (SEC)
Baseline : Malaise · Yes
|
2 Participants
|
5 Participants
|
|
Side Effects Checklist (SEC)
Baseline : Malaise · No
|
16 Participants
|
13 Participants
|
|
Side Effects Checklist (SEC)
Baseline : Stiffness · Yes
|
5 Participants
|
5 Participants
|
|
Side Effects Checklist (SEC)
Baseline : Stiffness · No
|
13 Participants
|
13 Participants
|
|
Side Effects Checklist (SEC)
Baseline : Tremor · Yes
|
1 Participants
|
3 Participants
|
|
Side Effects Checklist (SEC)
Baseline : Tremor · No
|
17 Participants
|
15 Participants
|
|
Side Effects Checklist (SEC)
Baseline : Dizziness · Yes
|
3 Participants
|
2 Participants
|
|
Side Effects Checklist (SEC)
Baseline : Dizziness · No
|
15 Participants
|
16 Participants
|
|
Side Effects Checklist (SEC)
Baseline : Headache · Yes
|
2 Participants
|
4 Participants
|
|
Side Effects Checklist (SEC)
Baseline : Headache · No
|
16 Participants
|
14 Participants
|
|
Side Effects Checklist (SEC)
Baseline : Fever · Yes
|
0 Participants
|
0 Participants
|
|
Side Effects Checklist (SEC)
Baseline : Fever · No
|
18 Participants
|
18 Participants
|
|
Side Effects Checklist (SEC)
Baseline : Sore Throat · Yes
|
1 Participants
|
2 Participants
|
|
Side Effects Checklist (SEC)
Baseline : Sore Throat · No
|
17 Participants
|
16 Participants
|
|
Side Effects Checklist (SEC)
Baseline : Dry Mouth · Yes
|
5 Participants
|
9 Participants
|
|
Side Effects Checklist (SEC)
Baseline : Dry Mouth · No
|
13 Participants
|
9 Participants
|
|
Side Effects Checklist (SEC)
Baseline : Hypersalivation · Yes
|
1 Participants
|
1 Participants
|
|
Side Effects Checklist (SEC)
Baseline : Hypersalivation · No
|
17 Participants
|
17 Participants
|
|
Side Effects Checklist (SEC)
Baseline : Enuresis · Yes
|
0 Participants
|
2 Participants
|
|
Side Effects Checklist (SEC)
Baseline : Enuresis · No
|
18 Participants
|
16 Participants
|
|
Side Effects Checklist (SEC)
Baseline : Constipation · Yes
|
1 Participants
|
1 Participants
|
|
Side Effects Checklist (SEC)
Baseline : Constipation · No
|
17 Participants
|
17 Participants
|
|
Side Effects Checklist (SEC)
Baseline : Diarrhea · Yes
|
2 Participants
|
1 Participants
|
|
Side Effects Checklist (SEC)
Baseline : Diarrhea · No
|
16 Participants
|
17 Participants
|
|
Side Effects Checklist (SEC)
Baseline : Anorexia · Yes
|
0 Participants
|
4 Participants
|
|
Side Effects Checklist (SEC)
Baseline : Anorexia · No
|
18 Participants
|
14 Participants
|
|
Side Effects Checklist (SEC)
Baseline : Nausea · Yes
|
0 Participants
|
2 Participants
|
|
Side Effects Checklist (SEC)
Baseline : Nausea · No
|
18 Participants
|
16 Participants
|
|
Side Effects Checklist (SEC)
Baseline : Vomiting · Yes
|
0 Participants
|
2 Participants
|
|
Side Effects Checklist (SEC)
Baseline : Vomiting · No
|
18 Participants
|
16 Participants
|
|
Side Effects Checklist (SEC)
Baseline : Menstrual Irregularities · Yes
|
0 Participants
|
0 Participants
|
|
Side Effects Checklist (SEC)
Baseline : Menstrual Irregularities · No
|
18 Participants
|
18 Participants
|
|
Side Effects Checklist (SEC)
Baseline : Breast Tenderness/Galactorrhea · Yes
|
0 Participants
|
0 Participants
|
|
Side Effects Checklist (SEC)
Baseline : Breast Tenderness/Galactorrhea · No
|
18 Participants
|
18 Participants
|
|
Side Effects Checklist (SEC)
Week 8 : Bruising easily · Yes
|
0 Participants
|
0 Participants
|
|
Side Effects Checklist (SEC)
Week 8 : Bruising easily · No
|
17 Participants
|
15 Participants
|
|
Side Effects Checklist (SEC)
Week 8 : Rash · Yes
|
2 Participants
|
1 Participants
|
|
Side Effects Checklist (SEC)
Week 8 : Rash · No
|
15 Participants
|
14 Participants
|
|
Side Effects Checklist (SEC)
Week 8 : Urticaria (Hives, Itching) · Yes
|
2 Participants
|
3 Participants
|
|
Side Effects Checklist (SEC)
Week 8 : Urticaria (Hives, Itching) · No
|
15 Participants
|
12 Participants
|
|
Side Effects Checklist (SEC)
Week 8 : Blurred Vision · Yes
|
1 Participants
|
1 Participants
|
|
Side Effects Checklist (SEC)
Week 8 : Blurred Vision · No
|
16 Participants
|
14 Participants
|
|
Side Effects Checklist (SEC)
Week 8 : Sedation/Drowsiness · Yes
|
3 Participants
|
3 Participants
|
|
Side Effects Checklist (SEC)
Week 8 : Sedation/Drowsiness · No
|
14 Participants
|
12 Participants
|
|
Side Effects Checklist (SEC)
Week 8 : Restlessness · Yes
|
2 Participants
|
6 Participants
|
|
Side Effects Checklist (SEC)
Week 8 : Restlessness · No
|
15 Participants
|
9 Participants
|
|
Side Effects Checklist (SEC)
Week 8 : Insomnia · Yes
|
4 Participants
|
3 Participants
|
|
Side Effects Checklist (SEC)
Week 8 : Insomnia · No
|
13 Participants
|
12 Participants
|
|
Side Effects Checklist (SEC)
Week 8 : Malaise · Yes
|
3 Participants
|
1 Participants
|
|
Side Effects Checklist (SEC)
Week 8 : Malaise · No
|
14 Participants
|
14 Participants
|
|
Side Effects Checklist (SEC)
Week 8 : Stiffness · Yes
|
1 Participants
|
3 Participants
|
|
Side Effects Checklist (SEC)
Week 8 : Stiffness · No
|
16 Participants
|
12 Participants
|
|
Side Effects Checklist (SEC)
Week 8 : Tremor · Yes
|
0 Participants
|
1 Participants
|
|
Side Effects Checklist (SEC)
Week 8 : Tremor · No
|
17 Participants
|
14 Participants
|
|
Side Effects Checklist (SEC)
Week 8 : Dizziness · Yes
|
3 Participants
|
2 Participants
|
|
Side Effects Checklist (SEC)
Week 8 : Dizziness · No
|
14 Participants
|
13 Participants
|
|
Side Effects Checklist (SEC)
Week 8 : Headache · Yes
|
0 Participants
|
2 Participants
|
|
Side Effects Checklist (SEC)
Week 8 : Headache · No
|
17 Participants
|
13 Participants
|
|
Side Effects Checklist (SEC)
Week 8 : Fever · Yes
|
0 Participants
|
0 Participants
|
|
Side Effects Checklist (SEC)
Week 8 : Fever · No
|
17 Participants
|
15 Participants
|
|
Side Effects Checklist (SEC)
Week 8 : Sore Throat · Yes
|
0 Participants
|
2 Participants
|
|
Side Effects Checklist (SEC)
Week 8 : Sore Throat · No
|
17 Participants
|
13 Participants
|
|
Side Effects Checklist (SEC)
Week 8 : Dry Mouth · Yes
|
3 Participants
|
5 Participants
|
|
Side Effects Checklist (SEC)
Week 8 : Dry Mouth · No
|
14 Participants
|
10 Participants
|
|
Side Effects Checklist (SEC)
Week 8 : Hypersalivation · Yes
|
1 Participants
|
1 Participants
|
|
Side Effects Checklist (SEC)
Week 8 : Hypersalivation · No
|
16 Participants
|
14 Participants
|
|
Side Effects Checklist (SEC)
Week 8 : Enuresis · Yes
|
0 Participants
|
1 Participants
|
|
Side Effects Checklist (SEC)
Week 8 : Enuresis · No
|
17 Participants
|
14 Participants
|
|
Side Effects Checklist (SEC)
Week 8 : Constipation · Yes
|
1 Participants
|
0 Participants
|
|
Side Effects Checklist (SEC)
Week 8 : Constipation · No
|
16 Participants
|
15 Participants
|
|
Side Effects Checklist (SEC)
Week 8 : Diarrhea · Yes
|
1 Participants
|
2 Participants
|
|
Side Effects Checklist (SEC)
Week 8 : Diarrhea · No
|
16 Participants
|
13 Participants
|
|
Side Effects Checklist (SEC)
Week 8 : Anorexia · Yes
|
2 Participants
|
1 Participants
|
|
Side Effects Checklist (SEC)
Week 8 : Anorexia · No
|
15 Participants
|
14 Participants
|
|
Side Effects Checklist (SEC)
Week 8 : Nausea · Yes
|
0 Participants
|
1 Participants
|
|
Side Effects Checklist (SEC)
Week 8 : Nausea · No
|
17 Participants
|
14 Participants
|
|
Side Effects Checklist (SEC)
Week 8 : Vomiting · Yes
|
0 Participants
|
0 Participants
|
|
Side Effects Checklist (SEC)
Week 8 : Vomiting · No
|
17 Participants
|
15 Participants
|
|
Side Effects Checklist (SEC)
Week 8 : Menstrual Irregularities · Yes
|
0 Participants
|
0 Participants
|
|
Side Effects Checklist (SEC)
Week 8 : Menstrual Irregularities · No
|
17 Participants
|
15 Participants
|
|
Side Effects Checklist (SEC)
Week 8 : Breast Tenderness/Galactorrhea · Yes
|
0 Participants
|
0 Participants
|
|
Side Effects Checklist (SEC)
Week 8 : Breast Tenderness/Galactorrhea · No
|
17 Participants
|
15 Participants
|
|
Side Effects Checklist (SEC)
Month 6 : Bruising easily · Yes
|
1 Participants
|
0 Participants
|
|
Side Effects Checklist (SEC)
Month 6 : Bruising easily · No
|
5 Participants
|
4 Participants
|
|
Side Effects Checklist (SEC)
Month 6 : Rash · Yes
|
0 Participants
|
0 Participants
|
|
Side Effects Checklist (SEC)
Month 6 : Rash · No
|
6 Participants
|
4 Participants
|
|
Side Effects Checklist (SEC)
Month 6 : Urticaria (Hives, Itching) · Yes
|
0 Participants
|
1 Participants
|
|
Side Effects Checklist (SEC)
Month 6 : Urticaria (Hives, Itching) · No
|
6 Participants
|
3 Participants
|
|
Side Effects Checklist (SEC)
Month 6 : Blurred Vision · Yes
|
0 Participants
|
0 Participants
|
|
Side Effects Checklist (SEC)
Month 6 : Blurred Vision · No
|
6 Participants
|
4 Participants
|
|
Side Effects Checklist (SEC)
Month 6 : Sedation/Drowsiness · Yes
|
1 Participants
|
2 Participants
|
|
Side Effects Checklist (SEC)
Month 6 : Sedation/Drowsiness · No
|
5 Participants
|
2 Participants
|
|
Side Effects Checklist (SEC)
Month 6 : Restlessness · Yes
|
2 Participants
|
0 Participants
|
|
Side Effects Checklist (SEC)
Month 6 : Restlessness · No
|
4 Participants
|
4 Participants
|
|
Side Effects Checklist (SEC)
Month 6 : Insomnia · Yes
|
1 Participants
|
0 Participants
|
|
Side Effects Checklist (SEC)
Month 6 : Insomnia · No
|
5 Participants
|
4 Participants
|
|
Side Effects Checklist (SEC)
Month 6 : Malaise · Yes
|
0 Participants
|
0 Participants
|
|
Side Effects Checklist (SEC)
Month 6 : Malaise · No
|
6 Participants
|
4 Participants
|
|
Side Effects Checklist (SEC)
Month 6 : Stiffness · Yes
|
0 Participants
|
1 Participants
|
|
Side Effects Checklist (SEC)
Month 6 : Stiffness · No
|
6 Participants
|
3 Participants
|
|
Side Effects Checklist (SEC)
Month 6 : Tremor · Yes
|
0 Participants
|
1 Participants
|
|
Side Effects Checklist (SEC)
Month 6 : Tremor · No
|
6 Participants
|
3 Participants
|
|
Side Effects Checklist (SEC)
Month 6 : Dizziness · Yes
|
1 Participants
|
1 Participants
|
|
Side Effects Checklist (SEC)
Month 6 : Dizziness · No
|
5 Participants
|
3 Participants
|
|
Side Effects Checklist (SEC)
Month 6 : Headache · Yes
|
0 Participants
|
2 Participants
|
|
Side Effects Checklist (SEC)
Month 6 : Headache · No
|
6 Participants
|
2 Participants
|
|
Side Effects Checklist (SEC)
Month 6 : Fever · Yes
|
0 Participants
|
0 Participants
|
|
Side Effects Checklist (SEC)
Month 6 : Fever · No
|
6 Participants
|
4 Participants
|
|
Side Effects Checklist (SEC)
Month 6 : Sore Throat · Yes
|
1 Participants
|
0 Participants
|
|
Side Effects Checklist (SEC)
Month 6 : Sore Throat · No
|
5 Participants
|
4 Participants
|
|
Side Effects Checklist (SEC)
Month 6 : Dry Mouth · Yes
|
2 Participants
|
0 Participants
|
|
Side Effects Checklist (SEC)
Month 6 : Dry Mouth · No
|
4 Participants
|
4 Participants
|
|
Side Effects Checklist (SEC)
Month 6 : Hypersalivation · Yes
|
2 Participants
|
0 Participants
|
|
Side Effects Checklist (SEC)
Month 6 : Hypersalivation · No
|
4 Participants
|
4 Participants
|
|
Side Effects Checklist (SEC)
Month 6 : Enuresis · Yes
|
0 Participants
|
0 Participants
|
|
Side Effects Checklist (SEC)
Month 6 : Enuresis · No
|
6 Participants
|
4 Participants
|
|
Side Effects Checklist (SEC)
Month 6 : Constipation · Yes
|
0 Participants
|
1 Participants
|
|
Side Effects Checklist (SEC)
Month 6 : Constipation · No
|
6 Participants
|
3 Participants
|
|
Side Effects Checklist (SEC)
Month 6 : Diarrhea · Yes
|
2 Participants
|
1 Participants
|
|
Side Effects Checklist (SEC)
Month 6 : Diarrhea · No
|
4 Participants
|
3 Participants
|
|
Side Effects Checklist (SEC)
Month 6 : Anorexia · Yes
|
1 Participants
|
0 Participants
|
|
Side Effects Checklist (SEC)
Month 6 : Anorexia · No
|
5 Participants
|
4 Participants
|
|
Side Effects Checklist (SEC)
Month 6 : Nausea · Yes
|
1 Participants
|
1 Participants
|
|
Side Effects Checklist (SEC)
Month 6 : Nausea · No
|
5 Participants
|
3 Participants
|
|
Side Effects Checklist (SEC)
Month 6 : Vomiting · Yes
|
1 Participants
|
0 Participants
|
|
Side Effects Checklist (SEC)
Month 6 : Vomiting · No
|
5 Participants
|
4 Participants
|
|
Side Effects Checklist (SEC)
Month 6 : Menstrual Irregularities · Yes
|
0 Participants
|
0 Participants
|
|
Side Effects Checklist (SEC)
Month 6 : Menstrual Irregularities · No
|
6 Participants
|
4 Participants
|
|
Side Effects Checklist (SEC)
Month 6 : Breast Tenderness/Galactorrhea · Yes
|
0 Participants
|
0 Participants
|
|
Side Effects Checklist (SEC)
Month 6 : Breast Tenderness/Galactorrhea · No
|
6 Participants
|
4 Participants
|
Adverse Events
D-cycloserine
Placebo
Serious adverse events
| Measure |
D-cycloserine
n=18 participants at risk
Participants will receive D-cycloserine weekly, one hour before the first cognitive remediation session of the week, for eight weeks.
D-cycloserine: 50 mg by mouth one hour before first cognitive remediation session each week for eight weeks.
Cognitive Remediation: 40 one-hour daily sessions of cognitive remediation (Brain Fitness Program) over eight weeks.
|
Placebo
n=18 participants at risk
Participants will receive placebo weekly, one hour before the first cognitive remediation session of the week, for eight weeks.
Placebo: Placebo by mouth one hour before first cognitive remediation session each week for eight weeks.
Cognitive Remediation: 40 one-hour daily sessions of cognitive remediation (Brain Fitness Program) over eight weeks.
|
|---|---|---|
|
Psychiatric disorders
Hospitalization
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
Other adverse events
| Measure |
D-cycloserine
n=18 participants at risk
Participants will receive D-cycloserine weekly, one hour before the first cognitive remediation session of the week, for eight weeks.
D-cycloserine: 50 mg by mouth one hour before first cognitive remediation session each week for eight weeks.
Cognitive Remediation: 40 one-hour daily sessions of cognitive remediation (Brain Fitness Program) over eight weeks.
|
Placebo
n=18 participants at risk
Participants will receive placebo weekly, one hour before the first cognitive remediation session of the week, for eight weeks.
Placebo: Placebo by mouth one hour before first cognitive remediation session each week for eight weeks.
Cognitive Remediation: 40 one-hour daily sessions of cognitive remediation (Brain Fitness Program) over eight weeks.
|
|---|---|---|
|
Cardiac disorders
Bradycardia
|
22.2%
4/18 • Number of events 8
|
0.00%
0/18
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
|
General disorders
Drowsiness
|
11.1%
2/18 • Number of events 2
|
0.00%
0/18
|
|
Cardiac disorders
Hypertension
|
77.8%
14/18 • Number of events 32
|
72.2%
13/18 • Number of events 22
|
|
Cardiac disorders
Hypotension
|
5.6%
1/18 • Number of events 1
|
5.6%
1/18 • Number of events 1
|
|
Infections and infestations
Infection
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
|
General disorders
Insomnia
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
Cardiac disorders
Tachycardia
|
44.4%
8/18 • Number of events 15
|
33.3%
6/18 • Number of events 13
|
Additional Information
Dr. Donald C Goff
Nathan Klein Institute for Psychiatric Research
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place