Schizophrenia
Conditions
Keywords
Schizophrenia
Brief summary
This study is designed to assess the effects of AZD 2624 in patients with schizophrenia
Interventions
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Females of non-childbearing potential * Diagnosis of Schizophrenia
Exclusion criteria
* Clinically relevant disease and /or abnormalities. * Alcohol or substance abuse not in remission * Enrollment in another investigational study within 30 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Positive and Negative Syndrome Scale (PANSS) Total Score Change From Baseline | Baseline, Day 28 | 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. |
Countries
United States
Participant flow
Recruitment details
A total of 2 centers in the US were initiated and enrolled patients. 159 patients enrolled, of which 106 randomized
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| AZD2624 AZD2624 40 mg | 43 |
| Placebo Matching Placebo | 41 |
| Olanzapine Olanzapine 15 mg | 22 |
| Total | 106 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 3 | 2 | 1 |
| Overall Study | Lack of Efficacy | 7 | 5 | 0 |
| Overall Study | Other | 0 | 0 | 1 |
| Overall Study | Safety Reasons | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 1 | 2 |
Baseline characteristics
| Characteristic | AZD2624 | Placebo | Olanzapine | Total |
|---|---|---|---|---|
| Age Continuous | 40.1 Year STANDARD_DEVIATION 12 | 40.2 Year STANDARD_DEVIATION 11.6 | 35.3 Year STANDARD_DEVIATION 8.7 | 39.2 Year STANDARD_DEVIATION 11.3 |
| Sex: Female, Male Female | 3 Participants | 2 Participants | 0 Participants | 5 Participants |
| Sex: Female, Male Male | 40 Participants | 39 Participants | 22 Participants | 101 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 29 / 43 | 27 / 41 | 18 / 22 |
| serious Total, serious adverse events | 4 / 43 | 2 / 41 | 0 / 22 |
Outcome results
Primary
Positive and Negative Syndrome Scale (PANSS) Total Score Change From Baseline
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.
Time frame: Baseline, Day 28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AZD2624 | Positive and Negative Syndrome Scale (PANSS) Total Score Change From Baseline | 1.40 Points on a scale | Standard Error 2.27 |
| Placebo | Positive and Negative Syndrome Scale (PANSS) Total Score Change From Baseline | 4.51 Points on a scale | Standard Error 2.35 |
| Olanzapine | Positive and Negative Syndrome Scale (PANSS) Total Score Change From Baseline | -8.79 Points on a scale | Standard Error 3.2 |