Trial Outcomes & Findings for Phase IIA Study in Patients With Schizophrenia (NCT NCT00686998)
NCT ID: NCT00686998
Last Updated: 2013-03-29
Results Overview
PANSS total score, sum of 30 item scores (each on a 0 to 7 scale), assesses positive and negative symptoms of psychopathology on a continuous scale from 0 (the best) to 210 (the worst). Day 28 value was calculated using last observation carried forward (LOCF). Change from baseline was calculated as Day 28 value minus baseline value.
COMPLETED
PHASE2
106 participants
Baseline, Day 28
2013-03-29
Participant Flow
A total of 2 centers in the US were initiated and enrolled patients. 159 patients enrolled, of which 106 randomized
Patients were screened up to 21 days, and admitted to the Clinical Research Unit (CRU) for a maximum of 2 days until eligibility was determined. Once eligibility was determined, patients currently on medication entered a 7 days washout period, patients not currently on medication had a 3 day washout, prior to randomization to study medication.
Participant milestones
| Measure |
AZD2624
AZD2624 40 mg
|
Placebo
Matching Placebo
|
Olanzapine
Olanzapine 15 mg
|
|---|---|---|---|
|
Overall Study
STARTED
|
43
|
41
|
22
|
|
Overall Study
Randomized
|
43
|
41
|
22
|
|
Overall Study
Received Treatment
|
43
|
41
|
22
|
|
Overall Study
Eligible for Efficacy Analysis
|
42
|
39
|
21
|
|
Overall Study
Completed Scheduled Treatment
|
30
|
33
|
18
|
|
Overall Study
COMPLETED
|
30
|
33
|
18
|
|
Overall Study
NOT COMPLETED
|
13
|
8
|
4
|
Reasons for withdrawal
| Measure |
AZD2624
AZD2624 40 mg
|
Placebo
Matching Placebo
|
Olanzapine
Olanzapine 15 mg
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
3
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
2
|
|
Overall Study
Lack of Efficacy
|
7
|
5
|
0
|
|
Overall Study
Other
|
0
|
0
|
1
|
|
Overall Study
Safety Reasons
|
1
|
0
|
0
|
Baseline Characteristics
Phase IIA Study in Patients With Schizophrenia
Baseline characteristics by cohort
| Measure |
AZD2624
n=43 Participants
AZD2624 40 mg
|
Placebo
n=41 Participants
Matching Placebo
|
Olanzapine
n=22 Participants
Olanzapine 15 mg
|
Total
n=106 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
40.1 Year
STANDARD_DEVIATION 12 • n=5 Participants
|
40.2 Year
STANDARD_DEVIATION 11.6 • n=7 Participants
|
35.3 Year
STANDARD_DEVIATION 8.7 • n=5 Participants
|
39.2 Year
STANDARD_DEVIATION 11.3 • n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
101 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 28PANSS total score, sum of 30 item scores (each on a 0 to 7 scale), assesses positive and negative symptoms of psychopathology on a continuous scale from 0 (the best) to 210 (the worst). Day 28 value was calculated using last observation carried forward (LOCF). Change from baseline was calculated as Day 28 value minus baseline value.
Outcome measures
| Measure |
AZD2624
n=42 Participants
AZD2624 40 mg
|
Placebo
n=39 Participants
Placebo
|
Olanzapine
n=21 Participants
Olanzapine 15 mg
|
|---|---|---|---|
|
Positive and Negative Syndrome Scale (PANSS) Total Score Change From Baseline
|
1.40 Points on a scale
Standard Error 2.27
|
4.51 Points on a scale
Standard Error 2.35
|
-8.79 Points on a scale
Standard Error 3.2
|
Adverse Events
AZD2624
Placebo
Olanzapine
Serious adverse events
| Measure |
AZD2624
n=43 participants at risk
AZD2624 40 mg
|
Placebo
n=41 participants at risk
Matching Placebo
|
Olanzapine
n=22 participants at risk
Olanzapine 15 mg
|
|---|---|---|---|
|
Psychiatric disorders
Psychotic disorder
|
9.3%
4/43
|
4.9%
2/41
|
0.00%
0/22
|
Other adverse events
| Measure |
AZD2624
n=43 participants at risk
AZD2624 40 mg
|
Placebo
n=41 participants at risk
Matching Placebo
|
Olanzapine
n=22 participants at risk
Olanzapine 15 mg
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
16.3%
7/43
|
0.00%
0/41
|
13.6%
3/22
|
|
Investigations
Weight Increased
|
0.00%
0/43
|
0.00%
0/41
|
40.9%
9/22
|
|
Nervous system disorders
Sedation
|
9.3%
4/43
|
2.4%
1/41
|
13.6%
3/22
|
|
Nervous system disorders
Somnolence
|
7.0%
3/43
|
2.4%
1/41
|
18.2%
4/22
|
|
Gastrointestinal disorders
Vomiting
|
14.0%
6/43
|
2.4%
1/41
|
4.5%
1/22
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
2.3%
1/43
|
12.2%
5/41
|
4.5%
1/22
|
|
Gastrointestinal disorders
Nausea
|
11.6%
5/43
|
2.4%
1/41
|
4.5%
1/22
|
|
Psychiatric disorders
Psychotic Disorder
|
9.3%
4/43
|
7.3%
3/41
|
0.00%
0/22
|
|
Gastrointestinal disorders
Constipation
|
2.3%
1/43
|
9.8%
4/41
|
4.5%
1/22
|
|
Nervous system disorders
Dizziness
|
2.3%
1/43
|
9.8%
4/41
|
0.00%
0/22
|
|
Metabolism and nutrition disorders
Increased Appetite
|
0.00%
0/43
|
2.4%
1/41
|
18.2%
4/22
|
|
Gastrointestinal disorders
Stomach Discomfort
|
4.7%
2/43
|
7.3%
3/41
|
0.00%
0/22
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
7.0%
3/43
|
2.4%
1/41
|
0.00%
0/22
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/43
|
7.3%
3/41
|
0.00%
0/22
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/43
|
0.00%
0/41
|
9.1%
2/22
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60