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The purpose of this study is to compare the efficacy and tolerability of aripiprazole to olanzapine over 26 weeks for the treatment of schizophrenia
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A1 | Active Comparator |
| |
| B1 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aripiprazole | Drug | Tablets, Oral, 15-30 mg, once daily, 140 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| The mean change in the PANSS Total Score | from baseline to Week 6 | |
| The percentage of patients showing significant weight gain (a≥ 7% increase) | from baseline to Week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline on the CGI-S Score | at the end of study | |
| Change from baseline on PANSS Total Score | at the end of study | |
| Change from baseline on PANSS-Positive Scale Total Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18986646 | Background | Fleischhacker WW, McQuade RD, Marcus RN, Archibald D, Swanink R, Carson WH. A double-blind, randomized comparative study of aripiprazole and olanzapine in patients with schizophrenia. Biol Psychiatry. 2009 Mar 15;65(6):510-7. doi: 10.1016/j.biopsych.2008.07.033. Epub 2008 Nov 4. |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000068180 | Aripiprazole |
| D000077152 | Olanzapine |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D015363 | Quinolones |
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| Olanzapine | Drug | Capsule, Oral, 10-20 mg, once daily, 140 weeks |
|
| at the end of study |
| Change from baseline on PANSS-Negative Scale Total Score | at the end of study |
| Mean change from baseline in PANSS-derived Brief Psychiatric Rating Scale (BPRS) Core Score | at the end of study |
| Mean CGI-I Score | at the end of study |
| Percentage of responders (≥ 30% decrease in PANSS Total Score, or score of 1 or 2 on CGI-I) | at the end of study |
| Change from baseline on the MADRS | at the end of study |
| Safety and tolerability | at the end of study |
| D011804 |
| Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |