Trial Outcomes & Findings for This is a Study to Determine the Antidepressant Effects of AZD6765 (NCT NCT00986479)
NCT ID: NCT00986479
Last Updated: 2014-10-21
Results Overview
Montgomery-Asberg Depression Rating Scale (MADRS) is a 10-item instrument used for the evaluation of depressive symptoms. Each item is rated on a scale of 0 to 6 (with higher scores indicating more severe depression). The individual item scores are added together to form a total score, ranging between 0 and 60. 0 is considered the best score, 60 the worst.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
22 participants
Primary outcome timeframe
60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing.
Results posted on
2014-10-21
Participant Flow
A total of 27 patients were enrolled. Of these, 22 patients were randomized to either: (1) AZD6765 (150 mg) followed by placebo or (2) placebo followed by AZD6765 (150 mg) in a crossover study design. A total of 20 patients completed both treatment periods of the study.
Screening for eligibility and washout of restricted medications.
Participant milestones
| Measure |
AZD6765 (150 mg)
Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
|
Placebo
Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
|
|---|---|---|
|
Period 1
STARTED
|
12
|
10
|
|
Period 1
COMPLETED
|
10
|
10
|
|
Period 1
NOT COMPLETED
|
2
|
0
|
|
Period 2
STARTED
|
10
|
10
|
|
Period 2
COMPLETED
|
10
|
10
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
AZD6765 (150 mg)
Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
|
Placebo
Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
|
|---|---|---|
|
Period 1
Improved mood
|
1
|
0
|
|
Period 1
Administrative reasons
|
1
|
0
|
Baseline Characteristics
This is a Study to Determine the Antidepressant Effects of AZD6765
Baseline characteristics by cohort
| Measure |
AZD6765 (150 mg)/ Placebo
n=12 Participants
Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
|
Placebo/AZD6765 (150 mg)
n=10 Participants
Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.7 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
52.4 years
STANDARD_DEVIATION 10.5 • n=7 Participants
|
51.5 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing.Population: ITT population including all randomized patients who were given study treatment.
Montgomery-Asberg Depression Rating Scale (MADRS) is a 10-item instrument used for the evaluation of depressive symptoms. Each item is rated on a scale of 0 to 6 (with higher scores indicating more severe depression). The individual item scores are added together to form a total score, ranging between 0 and 60. 0 is considered the best score, 60 the worst.
Outcome measures
| Measure |
AZD6765 (150 mg)
n=22 Participants
Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
|
Placebo
n=20 Participants
Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
|
|---|---|---|
|
Montgomery-Asberg Depression Rating Scale (MADRS) Total Score.
60 minutes
|
26.881 Units on a scale
Standard Error 1.262
|
28.618 Units on a scale
Standard Error 1.314
|
|
Montgomery-Asberg Depression Rating Scale (MADRS) Total Score.
80 minutes
|
25.381 Units on a scale
Standard Error 1.262
|
29.718 Units on a scale
Standard Error 1.314
|
|
Montgomery-Asberg Depression Rating Scale (MADRS) Total Score.
110 minutes
|
25.835 Units on a scale
Standard Error 1.262
|
29.818 Units on a scale
Standard Error 1.314
|
|
Montgomery-Asberg Depression Rating Scale (MADRS) Total Score.
230 minutes
|
26.517 Units on a scale
Standard Error 1.262
|
29.418 Units on a scale
Standard Error 1.314
|
|
Montgomery-Asberg Depression Rating Scale (MADRS) Total Score.
Day 1
|
27.654 Units on a scale
Standard Error 1.262
|
29.118 Units on a scale
Standard Error 1.314
|
|
Montgomery-Asberg Depression Rating Scale (MADRS) Total Score.
Day 2
|
29.161 Units on a scale
Standard Error 1.288
|
31.368 Units on a scale
Standard Error 1.314
|
|
Montgomery-Asberg Depression Rating Scale (MADRS) Total Score.
Day 3
|
30.732 Units on a scale
Standard Error 1.288
|
30.368 Units on a scale
Standard Error 1.314
|
|
Montgomery-Asberg Depression Rating Scale (MADRS) Total Score.
Day 7
|
31.447 Units on a scale
Standard Error 1.288
|
31.222 Units on a scale
Standard Error 1.342
|
SECONDARY outcome
Timeframe: 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing.Population: ITT population including all randomized patients who were given study treatment.
Remission defined as a Montgomery-Asberg Depression Rating Scale (MADRS) total score \<10. MADRS is a 10-item instrument used for the evaluation of depressive symptoms. Each item is rated on a scale of 0 to 6 (with higher scores indicating more severe depression). The individual item scores are added together to form a total score, ranging between 0 and 60. 0 is considered the best score, 60 the worst.
Outcome measures
| Measure |
AZD6765 (150 mg)
n=22 Participants
Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
|
Placebo
n=20 Participants
Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
|
|---|---|---|
|
The Number of Participants With Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than 10 (MADRS Remission).
60 minutes
|
2 Participants
|
1 Participants
|
|
The Number of Participants With Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than 10 (MADRS Remission).
80 minutes
|
4 Participants
|
0 Participants
|
|
The Number of Participants With Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than 10 (MADRS Remission).
110 minutes
|
4 Participants
|
0 Participants
|
|
The Number of Participants With Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than 10 (MADRS Remission).
230 minutes
|
2 Participants
|
0 Participants
|
|
The Number of Participants With Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than 10 (MADRS Remission).
Day 1
|
2 Participants
|
0 Participants
|
|
The Number of Participants With Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than 10 (MADRS Remission).
Day 2
|
1 Participants
|
0 Participants
|
|
The Number of Participants With Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than 10 (MADRS Remission).
Day 3
|
1 Participants
|
0 Participants
|
|
The Number of Participants With Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than 10 (MADRS Remission).
Day 7
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing.Population: ITT population including all randomized patients who were given study treatment.
Response defined as a \>= 50% reduction from baseline in MADRS total score. MADRS is a 10-item instrument used for the evaluation of depressive symptoms. Each item is rated on a scale of 0 to 6 (with higher scores indicating more severe depression). The individual item scores are added together to form a total score, ranging between 0 and 60. 0 is considered the best score, 60 the worst.
Outcome measures
| Measure |
AZD6765 (150 mg)
n=22 Participants
Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
|
Placebo
n=20 Participants
Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
|
|---|---|---|
|
The Number of Participants With at Least 50% Reduction in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (MADRS Response).
60 minutes
|
5 Participants
|
3 Participants
|
|
The Number of Participants With at Least 50% Reduction in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (MADRS Response).
80 minutes
|
6 Participants
|
1 Participants
|
|
The Number of Participants With at Least 50% Reduction in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (MADRS Response).
110 minutes
|
4 Participants
|
0 Participants
|
|
The Number of Participants With at Least 50% Reduction in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (MADRS Response).
230 minutes
|
4 Participants
|
1 Participants
|
|
The Number of Participants With at Least 50% Reduction in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (MADRS Response).
Day 1
|
3 Participants
|
0 Participants
|
|
The Number of Participants With at Least 50% Reduction in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (MADRS Response).
Day 2
|
1 Participants
|
0 Participants
|
|
The Number of Participants With at Least 50% Reduction in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (MADRS Response).
Day 3
|
1 Participants
|
0 Participants
|
|
The Number of Participants With at Least 50% Reduction in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (MADRS Response).
Day 7
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing.Population: ITT population including all randomized patients who were given study treatment.
Scale for Suicide Ideation (SSI) is a 19-item scale designed to quantify the intensity of current conscious suicide ideation. Each item is rated on a scale of 0 to 2 (with higher scores indicating greater suicidal ideation). The individual item scores are added together to form a total score, ranging between 0 and 38. 0 is considered the best outcome, 38 the worst.
Outcome measures
| Measure |
AZD6765 (150 mg)
n=22 Participants
Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
|
Placebo
n=20 Participants
Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
|
|---|---|---|
|
Scale for Suicide Ideation (SSI) Total Score.
60 minutes
|
0.955 Units on a scale
Standard Error 0.326
|
0.939 Units on a scale
Standard Error 0.330
|
|
Scale for Suicide Ideation (SSI) Total Score.
80 minutes
|
1.137 Units on a scale
Standard Error 0.326
|
1.039 Units on a scale
Standard Error 0.330
|
|
Scale for Suicide Ideation (SSI) Total Score.
110 minutes
|
1.137 Units on a scale
Standard Error 0.326
|
0.989 Units on a scale
Standard Error 0.330
|
|
Scale for Suicide Ideation (SSI) Total Score.
230 minutes
|
0.864 Units on a scale
Standard Error 0.326
|
0.939 Units on a scale
Standard Error 0.330
|
|
Scale for Suicide Ideation (SSI) Total Score.
Day 1
|
1.364 Units on a scale
Standard Error 0.326
|
1.539 Units on a scale
Standard Error 0.330
|
|
Scale for Suicide Ideation (SSI) Total Score.
Day 2
|
1.236 Units on a scale
Standard Error 0.328
|
1.189 Units on a scale
Standard Error 0.330
|
|
Scale for Suicide Ideation (SSI) Total Score.
Day 3
|
1.379 Units on a scale
Standard Error 0.328
|
1.226 Units on a scale
Standard Error 0.332
|
|
Scale for Suicide Ideation (SSI) Total Score.
Day 7
|
1.379 Units on a scale
Standard Error 0.328
|
1.507 Units on a scale
Standard Error 0.332
|
SECONDARY outcome
Timeframe: 60 minutes (min) prior to dosing (baseline); and 230 min, 1 day, 2 days, 3 days and 7 days following dosing.Hamilton Anxiety Rating Scale (HAM-A) is used as a rating measure of anxiety severity. The scale consists of 14 items. Each item is rated on a scale of 0 to 4. The HAM-A total score is the sum of the 14 items and the score ranges from 0 to 56. 0 is considered the best outcome, 56 the worst.
Outcome measures
| Measure |
AZD6765 (150 mg)
n=22 Participants
Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
|
Placebo
n=20 Participants
Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
|
|---|---|---|
|
Hamilton Anxiety Rating Scale (HAM-A) Total Score.
230 minutes
|
16.211 Units on a scale
Standard Error 1.181
|
17.160 Units on a scale
Standard Error 1.207
|
|
Hamilton Anxiety Rating Scale (HAM-A) Total Score.
Day 1
|
16.666 Units on a scale
Standard Error 1.181
|
17.675 Units on a scale
Standard Error 1.198
|
|
Hamilton Anxiety Rating Scale (HAM-A) Total Score.
Day 2
|
16.817 Units on a scale
Standard Error 1.190
|
18.125 Units on a scale
Standard Error 1.198
|
|
Hamilton Anxiety Rating Scale (HAM-A) Total Score.
Day 3
|
17.055 Units on a scale
Standard Error 1.190
|
18.525 Units on a scale
Standard Error 1.198
|
|
Hamilton Anxiety Rating Scale (HAM-A) Total Score.
Day 7
|
18.817 Units on a scale
Standard Error 1.190
|
19.631 Units on a scale
Standard Error 1.207
|
SECONDARY outcome
Timeframe: 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosingPopulation: ITT population including all randomized patients who were given study treatment.
Hamilton Depression Rating Scale-17 item (HDRS) is a scale that assesses depressive symptoms. HDRS consists of 17 symptoms, each of which is rated from 0 to 2 or 0 to 4, where 0 is none/absent. The total score is calculated as the sum of the 17 individual symptom scores; the total score can range from 0 to 52. Higher scores indicate more severe depression.
Outcome measures
| Measure |
AZD6765 (150 mg)
n=22 Participants
Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
|
Placebo
n=20 Participants
Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
|
|---|---|---|
|
Hamilton Depression Rating Scale-17 Item (HDRS) Total Score
60 minutes
|
15.930 Units on a scale
Standard Error 0.977
|
17.389 Units on a scale
Standard Error 1.008
|
|
Hamilton Depression Rating Scale-17 Item (HDRS) Total Score
80 minutes
|
14.975 Units on a scale
Standard Error 0.977
|
17.739 Units on a scale
Standard Error 1.008
|
|
Hamilton Depression Rating Scale-17 Item (HDRS) Total Score
110 minutes
|
15.475 Units on a scale
Standard Error 0.977
|
18.039 Units on a scale
Standard Error 1.008
|
|
Hamilton Depression Rating Scale-17 Item (HDRS) Total Score
230 minutes
|
16.112 Units on a scale
Standard Error 0.977
|
17.339 Units on a scale
Standard Error 1.008
|
|
Hamilton Depression Rating Scale-17 Item (HDRS) Total Score
Day 1
|
16.748 Units on a scale
Standard Error 0.977
|
17.639 Units on a scale
Standard Error 1.008
|
|
Hamilton Depression Rating Scale-17 Item (HDRS) Total Score
Day 2
|
16.732 Units on a scale
Standard Error 0.977
|
19.289 Units on a scale
Standard Error 1.008
|
|
Hamilton Depression Rating Scale-17 Item (HDRS) Total Score
Day 3
|
17.732 Units on a scale
Standard Error 0.977
|
19.039 Units on a scale
Standard Error 1.008
|
|
Hamilton Depression Rating Scale-17 Item (HDRS) Total Score
Day 7
|
18.160 Units on a scale
Standard Error 0.991
|
19.438 Units on a scale
Standard Error 1.024
|
SECONDARY outcome
Timeframe: 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosingPopulation: ITT population including all randomized patients who were given study treatment.
The Visual Analog Scale (VAS) Depressed is a 0 to 100-mm self-administered scale where patients rate their mood between "extreme sad" (0-mm) and "extreme happy" (100-mm), with a median "normal" point.
Outcome measures
| Measure |
AZD6765 (150 mg)
n=22 Participants
Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
|
Placebo
n=20 Participants
Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
|
|---|---|---|
|
Visual Analogue Scale (VAS) Depressed Score
60 minutes
|
55.614 Scores on a scale
Standard Error 6.137
|
60.562 Scores on a scale
Standard Error 6.197
|
|
Visual Analogue Scale (VAS) Depressed Score
80 minutes
|
58.614 Scores on a scale
Standard Error 6.137
|
57.662 Scores on a scale
Standard Error 6.197
|
|
Visual Analogue Scale (VAS) Depressed Score
110 minutes
|
60.750 Scores on a scale
Standard Error 6.137
|
59.062 Scores on a scale
Standard Error 6.197
|
|
Visual Analogue Scale (VAS) Depressed Score
230 minutes
|
55.614 Scores on a scale
Standard Error 6.137
|
61.212 Scores on a scale
Standard Error 6.197
|
|
Visual Analogue Scale (VAS) Depressed Score
Day 1
|
62.160 Scores on a scale
Standard Error 6.137
|
64.762 Scores on a scale
Standard Error 6.197
|
|
Visual Analogue Scale (VAS) Depressed Score
Day 2
|
65.753 Scores on a scale
Standard Error 6.166
|
63.262 Scores on a scale
Standard Error 6.197
|
|
Visual Analogue Scale (VAS) Depressed Score
Day 3
|
66.896 Scores on a scale
Standard Error 6.166
|
63.312 Scores on a scale
Standard Error 6.197
|
|
Visual Analogue Scale (VAS) Depressed Score
Day 7
|
68.467 Scores on a scale
Standard Error 6.166
|
65.576 Scores on a scale
Standard Error 6.264
|
SECONDARY outcome
Timeframe: 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosingPopulation: ITT population including all randomized patients who were given study treatment.
Clinician- Administered Dissociative States Scale (CADSS) is a clinician-administered measure of perceptual, behavioral, and attentional alterations occurring during dissociative experiences. This scale involves a 23 questions and each is rated from 0 (not at all) to 4 (extremely). The total score is sum of the 23 items and range from 0 to 92 - best is 0 and worst is 92.
Outcome measures
| Measure |
AZD6765 (150 mg)
n=22 Participants
Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
|
Placebo
n=20 Participants
Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
|
|---|---|---|
|
Clinician-Administered Dissociative States Scale (CADSS) Score.
60 minutes
|
4.104 Units on a scale
Standard Error 0.900
|
1.997 Units on a scale
Standard Error 0.921
|
|
Clinician-Administered Dissociative States Scale (CADSS) Score.
80 minutes
|
3.324 Units on a scale
Standard Error 0.909
|
2.297 Units on a scale
Standard Error 0.921
|
|
Clinician-Administered Dissociative States Scale (CADSS) Score.
110 minutes
|
2.831 Units on a scale
Standard Error 0.900
|
2.047 Units on a scale
Standard Error 0.921
|
|
Clinician-Administered Dissociative States Scale (CADSS) Score.
230 minutes
|
1.240 Units on a scale
Standard Error 0.900
|
1.497 Units on a scale
Standard Error 0.921
|
|
Clinician-Administered Dissociative States Scale (CADSS) Score.
Day 1
|
1.013 Units on a scale
Standard Error 0.900
|
1.147 Units on a scale
Standard Error 0.921
|
|
Clinician-Administered Dissociative States Scale (CADSS) Score.
Day 2
|
1.360 Units on a scale
Standard Error 0.910
|
1.397 Units on a scale
Standard Error 0.921
|
|
Clinician-Administered Dissociative States Scale (CADSS) Score.
Day 3
|
1.456 Units on a scale
Standard Error 0.910
|
1.447 Units on a scale
Standard Error 0.921
|
|
Clinician-Administered Dissociative States Scale (CADSS) Score.
Day 7
|
1.313 Units on a scale
Standard Error 0.910
|
1.212 Units on a scale
Standard Error 0.932
|
SECONDARY outcome
Timeframe: 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing.Population: ITT population including all randomized patients who were given study treatment.
The Brief Psychiatric Rating Scale (BPRS) is a 18-item scale which measures symptoms and behaviors that are characteristic of schizophrenia. Each item is rated from 1 to 7 with higher score indicating greater severity. The total score is the sum of the 18 items, resulting in a range of scores from 18-126. 18 is considered to be the best outcome, 126 the worst.
Outcome measures
| Measure |
AZD6765 (150 mg)
n=22 Participants
Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
|
Placebo
n=20 Participants
Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
|
|---|---|---|
|
Brief Psychiatric Rating Scale (BPRS) Score.
60 minutes
|
32.191 Units on a scale
Standard Error 1.271
|
32.896 Units on a scale
Standard Error 1.314
|
|
Brief Psychiatric Rating Scale (BPRS) Score.
80 minutes
|
30.237 Units on a scale
Standard Error 1.271
|
33.496 Units on a scale
Standard Error 1.314
|
|
Brief Psychiatric Rating Scale (BPRS) Score.
110 minutes
|
30.555 Units on a scale
Standard Error 1.271
|
33.696 Units on a scale
Standard Error 1.314
|
|
Brief Psychiatric Rating Scale (BPRS) Score.
230 minutes
|
30.737 Units on a scale
Standard Error 1.271
|
31.772 Units on a scale
Standard Error 1.314
|
|
Brief Psychiatric Rating Scale (BPRS) Score.
Day 1
|
33.418 Units on a scale
Standard Error 1.271
|
33.596 Units on a scale
Standard Error 1.314
|
|
Brief Psychiatric Rating Scale (BPRS) Score.
Day 2
|
32.882 Units on a scale
Standard Error 1.291
|
34.496 Units on a scale
Standard Error 1.314
|
|
Brief Psychiatric Rating Scale (BPRS) Score.
Day 3
|
34.168 Units on a scale
Standard Error 1.291
|
33.046 Units on a scale
Standard Error 1.314
|
|
Brief Psychiatric Rating Scale (BPRS) Score.
Day 7
|
35.739 Units on a scale
Standard Error 1.291
|
34.428 Units on a scale
Standard Error 1.335
|
SECONDARY outcome
Timeframe: 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing.Population: ITT population including all randomized patients who were given study treatment.
Beck Depression Inventory (BDI) is a 21-question instrument for measuring the severity of depression. Each question has a set of at least four possible answer choices, ranging in intensity. A value of 0 to 3 is assigned for each answer and the total score is computed. Higher total scores indicate more severe depressive symptoms.
Outcome measures
| Measure |
AZD6765 (150 mg)
n=22 Participants
Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
|
Placebo
n=20 Participants
Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
|
|---|---|---|
|
Beck Depression Inventory (BDI) Score.
60 minutes
|
21.081 Units on a scale
Standard Error 2.524
|
22.886 Units on a scale
Standard Error 2.538
|
|
Beck Depression Inventory (BDI) Score.
80 minutes
|
22.217 Units on a scale
Standard Error 2.524
|
23.122 Units on a scale
Standard Error 2.546
|
|
Beck Depression Inventory (BDI) Score.
110 minutes
|
21.535 Units on a scale
Standard Error 2.524
|
23.586 Units on a scale
Standard Error 2.538
|
|
Beck Depression Inventory (BDI) Score.
230 minutes
|
21.126 Units on a scale
Standard Error 2.524
|
23.686 Units on a scale
Standard Error 2.538
|
|
Beck Depression Inventory (BDI) Score.
Day 1
|
22.444 Units on a scale
Standard Error 2.524
|
22.936 Units on a scale
Standard Error 2.538
|
|
Beck Depression Inventory (BDI) Score.
Day 2
|
22.923 Units on a scale
Standard Error 2.531
|
24.586 Units on a scale
Standard Error 2.538
|
|
Beck Depression Inventory (BDI) Score.
Day 3
|
23.494 Units on a scale
Standard Error 2.531
|
23.786 Units on a scale
Standard Error 2.538
|
|
Beck Depression Inventory (BDI) Score.
Day 7
|
24.447 Units on a scale
Standard Error 2.531
|
24.070 Units on a scale
Standard Error 2.546
|
SECONDARY outcome
Timeframe: 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing.Population: ITT population including all randomized patients who were given study treatment.
Young Mania Rating Scale (YMRS) consists of 11 items, rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe) or from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60. 0 is considered to be the best outcome, 60 the worst.
Outcome measures
| Measure |
AZD6765 (150 mg)
n=22 Participants
Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
|
Placebo
n=20 Participants
Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
|
|---|---|---|
|
Young Mania Rating Scale (YMRS) Score.
60 minutes
|
4.294 Units on a scale
Standard Error 0.412
|
3.626 Units on a scale
Standard Error 0.427
|
|
Young Mania Rating Scale (YMRS) Score.
80 minutes
|
3.748 Units on a scale
Standard Error 0.412
|
3.526 Units on a scale
Standard Error 0.427
|
|
Young Mania Rating Scale (YMRS) Score.
110 minutes
|
3.475 Units on a scale
Standard Error 0.412
|
3.526 Units on a scale
Standard Error 0.427
|
|
Young Mania Rating Scale (YMRS) Score.
230 minutes
|
3.748 Units on a scale
Standard Error 0.412
|
3.526 Units on a scale
Standard Error 0.427
|
|
Young Mania Rating Scale (YMRS) Score.
Day 1
|
3.748 Units on a scale
Standard Error 0.412
|
3.326 Units on a scale
Standard Error 0.427
|
|
Young Mania Rating Scale (YMRS) Score.
Day 2
|
3.699 Units on a scale
Standard Error 0.419
|
3.676 Units on a scale
Standard Error 0.427
|
|
Young Mania Rating Scale (YMRS) Score.
Day 3
|
4.270 Units on a scale
Standard Error 0.419
|
3.476 Units on a scale
Standard Error 0.427
|
|
Young Mania Rating Scale (YMRS) Score.
Day 7
|
4.366 Units on a scale
Standard Error 0.419
|
4.339 Units on a scale
Standard Error 0.435
|
SECONDARY outcome
Timeframe: 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing.Population: ITT population including all randomized patients who were given study treatment.
The Visual Analog Scale (VAS) Anxious is a 0 to 100-mm self-administered scale where patients rate their mood between "extreme sad" (0-mm) and "extreme happy" (100-mm), with a median "normal" point.
Outcome measures
| Measure |
AZD6765 (150 mg)
n=22 Participants
Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
|
Placebo
n=20 Participants
Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
|
|---|---|---|
|
Visual Analogue Scale (VAS) Anxious Score.
60 minutes
|
43.898 Units on a scale
Standard Error 7.415
|
41.929 Units on a scale
Standard Error 7.479
|
|
Visual Analogue Scale (VAS) Anxious Score.
80 minutes
|
44.216 Units on a scale
Standard Error 7.415
|
44.079 Units on a scale
Standard Error 7.479
|
|
Visual Analogue Scale (VAS) Anxious Score.
110 minutes
|
42.853 Units on a scale
Standard Error 7.415
|
44.729 Units on a scale
Standard Error 7.479
|
|
Visual Analogue Scale (VAS) Anxious Score.
230 minutes
|
44.580 Units on a scale
Standard Error 7.415
|
46.029 Units on a scale
Standard Error 7.479
|
|
Visual Analogue Scale (VAS) Anxious Score.
Day 1
|
44.989 Units on a scale
Standard Error 7.415
|
47.229 Units on a scale
Standard Error 7.479
|
|
Visual Analogue Scale (VAS) Anxious Score.
Day 2
|
44.718 Units on a scale
Standard Error 7.447
|
50.479 Units on a scale
Standard Error 7.479
|
|
Visual Analogue Scale (VAS) Anxious Score.
Day 3
|
42.623 Units on a scale
Standard Error 7.447
|
48.279 Units on a scale
Standard Error 7.479
|
|
Visual Analogue Scale (VAS) Anxious Score.
Day 7
|
50.147 Units on a scale
Standard Error 7.447
|
56.595 Units on a scale
Standard Error 7.551
|
SECONDARY outcome
Timeframe: 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing.Brief Psychiatric Rating Scale (BPRS) Positive is a 4-item scale which measures positive symptoms of schizophrenia (conceptual disorganization, hallucinatory behavior, suspiciousness, and unusual thought content). Each item is rated from 1 to 7 with higher score indicating greater severity. The total score is the sum of the 4 items, resulting in a range of scores from 4-28.
Outcome measures
| Measure |
AZD6765 (150 mg)
n=22 Participants
Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
|
Placebo
n=20 Participants
Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
|
|---|---|---|
|
Brief Psychiatric Rating Scale (BPRS) Positive Score.
60 minutes
|
9.433 Units on a scale
Standard Error 0.264
|
8.946 Units on a scale
Standard Error 0.274
|
|
Brief Psychiatric Rating Scale (BPRS) Positive Score.
80 minutes
|
8.751 Units on a scale
Standard Error 0.264
|
8.996 Units on a scale
Standard Error 0.274
|
|
Brief Psychiatric Rating Scale (BPRS) Positive Score.
110 minutes
|
8.660 Units on a scale
Standard Error 0.264
|
8.996 Units on a scale
Standard Error 0.274
|
|
Brief Psychiatric Rating Scale (BPRS) Positive Score.
230 minutes
|
8.751 Units on a scale
Standard Error 0.264
|
8.666 Units on a scale
Standard Error 0.279
|
|
Brief Psychiatric Rating Scale (BPRS) Positive Score.
Day 1
|
9.114 Units on a scale
Standard Error 0.264
|
9.296 Units on a scale
Standard Error 0.274
|
|
Brief Psychiatric Rating Scale (BPRS) Positive Score.
Day 2
|
9.118 Units on a scale
Standard Error 0.269
|
9.296 Units on a scale
Standard Error 0.274
|
|
Brief Psychiatric Rating Scale (BPRS) Positive Score.
Day 3
|
9.118 Units on a scale
Standard Error 0.269
|
9.446 Units on a scale
Standard Error 0.274
|
|
Brief Psychiatric Rating Scale (BPRS) Positive Score.
Day 7
|
9.356 Units on a scale
Standard Error 0.269
|
9.338 Units on a scale
Standard Error 0.279
|
Adverse Events
AZD6765 (150 mg)
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
AZD6765 (150 mg)
n=22 participants at risk
Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
|
Placebo
n=20 participants at risk
Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
|
|---|---|---|
|
Cardiac disorders
Bradycardia
|
4.5%
1/22
|
5.0%
1/20
|
|
Vascular disorders
Hypertension
|
36.4%
8/22
|
25.0%
5/20
|
|
Vascular disorders
Hypotension
|
13.6%
3/22
|
5.0%
1/20
|
|
Cardiac disorders
Tachycardia
|
9.1%
2/22
|
10.0%
2/20
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
9.1%
2/22
|
0.00%
0/20
|
|
Ear and labyrinth disorders
Hypoacusis
|
4.5%
1/22
|
0.00%
0/20
|
|
Ear and labyrinth disorders
Tinnitus
|
4.5%
1/22
|
10.0%
2/20
|
|
Eye disorders
Vision blurred
|
9.1%
2/22
|
5.0%
1/20
|
|
Eye disorders
Eye irritation
|
4.5%
1/22
|
5.0%
1/20
|
|
Metabolism and nutrition disorders
Decreased apetite
|
40.9%
9/22
|
25.0%
5/20
|
|
Metabolism and nutrition disorders
Increased apetite
|
4.5%
1/22
|
5.0%
1/20
|
|
Gastrointestinal disorders
Constipation
|
13.6%
3/22
|
10.0%
2/20
|
|
Gastrointestinal disorders
Flatulence
|
9.1%
2/22
|
15.0%
3/20
|
|
Gastrointestinal disorders
Thirst
|
4.5%
1/22
|
0.00%
0/20
|
|
Gastrointestinal disorders
Nausea
|
22.7%
5/22
|
15.0%
3/20
|
|
Gastrointestinal disorders
Abdominal discomfort
|
27.3%
6/22
|
25.0%
5/20
|
|
Gastrointestinal disorders
Faeces discoloured
|
4.5%
1/22
|
5.0%
1/20
|
|
Nervous system disorders
Dysgeusia
|
4.5%
1/22
|
5.0%
1/20
|
|
Gastrointestinal disorders
Vomiting
|
9.1%
2/22
|
0.00%
0/20
|
|
Investigations
Weight increased
|
4.5%
1/22
|
0.00%
0/20
|
|
Investigations
Weight decreased
|
9.1%
2/22
|
5.0%
1/20
|
|
Nervous system disorders
Libido increased
|
4.5%
1/22
|
0.00%
0/20
|
|
Nervous system disorders
Felt faint
|
45.5%
10/22
|
15.0%
3/20
|
|
Nervous system disorders
Headache
|
9.1%
2/22
|
20.0%
4/20
|
|
Surgical and medical procedures
Dental care
|
4.5%
1/22
|
5.0%
1/20
|
|
Gastrointestinal disorders
Dry mouth
|
22.7%
5/22
|
15.0%
3/20
|
|
Gastrointestinal disorders
Gingival disorder
|
4.5%
1/22
|
0.00%
0/20
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
4.5%
1/22
|
0.00%
0/20
|
|
Gastrointestinal disorders
Mouth ulceration
|
4.5%
1/22
|
0.00%
0/20
|
|
Gastrointestinal disorders
Glossodynia
|
4.5%
1/22
|
5.0%
1/20
|
|
General disorders
Oedema
|
4.5%
1/22
|
5.0%
1/20
|
|
Musculoskeletal and connective tissue disorders
Muscle rigidity
|
9.1%
2/22
|
0.00%
0/20
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
13.6%
3/22
|
10.0%
2/20
|
|
Psychiatric disorders
Tic
|
4.5%
1/22
|
5.0%
1/20
|
|
Nervous system disorders
Tremor
|
13.6%
3/22
|
20.0%
4/20
|
|
Gastrointestinal disorders
Malignant dysphagia
|
4.5%
1/22
|
5.0%
1/20
|
|
Infections and infestations
Influenza
|
9.1%
2/22
|
5.0%
1/20
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
18.2%
4/22
|
10.0%
2/20
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
4.5%
1/22
|
5.0%
1/20
|
|
Psychiatric disorders
Anxiety
|
9.1%
2/22
|
15.0%
3/20
|
|
Psychiatric disorders
Disturbance in attention
|
45.5%
10/22
|
30.0%
6/20
|
|
Psychiatric disorders
Confusional state
|
27.3%
6/22
|
5.0%
1/20
|
|
Psychiatric disorders
Depression
|
18.2%
4/22
|
5.0%
1/20
|
|
Psychiatric disorders
Initial insomnia
|
31.8%
7/22
|
40.0%
8/20
|
|
Psychiatric disorders
Somnolence
|
68.2%
15/22
|
60.0%
12/20
|
|
Psychiatric disorders
Terminal insomnia
|
27.3%
6/22
|
35.0%
7/20
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/22
|
5.0%
1/20
|
|
Psychiatric disorders
Sleep disorder
|
45.5%
10/22
|
55.0%
11/20
|
|
Nervous system disorders
Irritability
|
45.5%
10/22
|
40.0%
8/20
|
|
Nervous system disorders
Memory impairment
|
22.7%
5/22
|
25.0%
5/20
|
|
Nervous system disorders
Hypokinesia
|
31.8%
7/22
|
30.0%
6/20
|
|
Psychiatric disorders
Psychomotor activity
|
22.7%
5/22
|
20.0%
4/20
|
|
Nervous system disorders
Dysarthria
|
13.6%
3/22
|
5.0%
1/20
|
|
Nervous system disorders
Suicidal behaviour
|
4.5%
1/22
|
0.00%
0/20
|
|
Nervous system disorders
Suicidal ideation
|
9.1%
2/22
|
15.0%
3/20
|
|
General disorders
Fatigue
|
27.3%
6/22
|
25.0%
5/20
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
13.6%
3/22
|
15.0%
3/20
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
9.1%
2/22
|
5.0%
1/20
|
|
General disorders
Pyrexia
|
9.1%
2/22
|
5.0%
1/20
|
|
Surgical and medical procedures
Surgery
|
4.5%
1/22
|
0.00%
0/20
|
|
Ear and labyrinth disorders
Hearing impaired
|
13.6%
3/22
|
10.0%
2/20
|
|
Investigations
Body temperature decreased
|
22.7%
5/22
|
20.0%
4/20
|
|
Psychiatric disorders
Dissociation
|
13.6%
3/22
|
10.0%
2/20
|
|
Nervous system disorders
Euphoric mood
|
13.6%
3/22
|
0.00%
0/20
|
|
Psychiatric disorders
Social avoindant behaviour
|
18.2%
4/22
|
15.0%
3/20
|
|
Nervous system disorders
Abnormal behaviour
|
36.4%
8/22
|
15.0%
3/20
|
|
Psychiatric disorders
Feeling abnormal
|
22.7%
5/22
|
15.0%
3/20
|
|
Investigations
Body temperature increased
|
22.7%
5/22
|
15.0%
3/20
|
|
General disorders
Energy increased
|
22.7%
5/22
|
5.0%
1/20
|
|
Nervous system disorders
Hypoaesthesia
|
27.3%
6/22
|
10.0%
2/20
|
|
Skin and subcutaneous tissue disorders
Rash
|
13.6%
3/22
|
0.00%
0/20
|
|
Psychiatric disorders
Fear of falling
|
9.1%
2/22
|
0.00%
0/20
|
|
Nervous system disorders
Paraesthesia
|
27.3%
6/22
|
10.0%
2/20
|
|
Eye disorders
Visual impairment
|
13.6%
3/22
|
5.0%
1/20
|
|
Nervous system disorders
Abnormal dreams
|
13.6%
3/22
|
25.0%
5/20
|
|
Psychiatric disorders
False Sensation
|
40.9%
9/22
|
30.0%
6/20
|
|
Nervous system disorders
Dizziness
|
45.5%
10/22
|
20.0%
4/20
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place