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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-021984-33 |
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This randomized, double-blind, placebo- and active-controlled, parallel group study will evaluate the safety and efficacy of RO4917838 (bitopertin) in patients with acute exacerbation of schizophrenia. Patients will be randomized to receive either RO4917838 10 mg or RO4917838 30 mg or olanzapine 15 mg or placebo orally daily for 4 weeks as inpatients, with a 4-week follow-up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Experimental |
| |
| C | Active Comparator |
| |
| D | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bitopertin [RO4917838] | Drug | 10 mg orally daily, 4 weeks |
| |
| bitopertin [RO4917838] |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Positive and Negative Syndrome Scale (PANSS) total score | from baseline to Day 28 | |
| Safety: Incidence adverse events | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical response, defined as at least 30% or 50% improvement from baseline PANSS total score | from baseline to Day 28 | |
| Change in symptomatology as measured by the PANSS factor and subscale scores | from baseline to Day 28 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Little Rock | Arkansas | 72201 | United States | |||
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| Drug |
30 mg orally daily, 4 weeks |
|
| olanzapine | Drug | 15 mg orally daily, 4 weeks |
|
| placebo | Drug | orally daily, 4 weeks |
|
| Global improvement as measured by the Clinical Global Impressions-Severity (CGI-S) scale | from baseline to Day 28 |
| Global improvement as measured by the Clinical Global Impressions-Change (CGI-C) rating scale | from baseline to Day 28 |
| Observable behavioural change as determined by the Nurses' Observation Scale For Inpatient Evaluation (NOSIE) | from baseline to Day 28 |
| Time to readiness for discharge from inpatient unit as assessed by the Readiness For Hospital Discharge Questionnaire (RDQ) | from baseline to Day 28 |
| Cerritos |
| California |
| 90703 |
| United States |
| Oceanside | California | 92056 | United States |
| Pico Rivera | California | 90660 | United States |
| San Diego | California | 92121 | United States |
| Lauderhill | Florida | 33021 | United States |
| North Miami | Florida | 33161 | United States |
| Atlanta | Georgia | 30308 | United States |
| Lake Charles | Louisiana | 70601 | United States |
| Flowood | Mississippi | 39232 | United States |
| St Louis | Missouri | 63141 | United States |
| Willingboro | New Jersey | 08046 | United States |
| Holliswood | New York | 11423 | United States |
| New York | New York | 11004 | United States |
| Cincinnati | Ohio | 45219 | United States |
| Philadelphia | Pennsylvania | 19139 | United States |
| Charlesston | South Carolina | 29405 | United States |
| Austin | Texas | 78754 | United States |
| Irving | Texas | 75062 | United States |
| Arad | 310022 | Romania |
| Bucharest | 010825 | Romania |
| Bucharest | 041902 | Romania |
| Bucharest | 041914 | Romania |
| Foscani | 620165 | Romania |
| Oradea | 410154 | Romania |
| Targoviste | 130086 | Romania |
| Gatchina | 188357 | Russia |
| Moscow | 117152 | Russia |
| Petrozavodsk | 186131 | Russia |
| Saint Petersburg | 190005 | Russia |
| Saint Petersburg | 192019 | Russia |
| Saint Petersburg | 193167 | Russia |
| Saint Petersburg | 194044 | Russia |
| Saint Petersburg | 197341 | Russia |
| Talagi | 163530 | Russia |
| Bojnice | 972 01 | Slovakia |
| Bratislava | 826 06 | Slovakia |
| Liptovský Mikuláš | 3123 | Slovakia |
| Michalovce | 071 01 | Slovakia |
| Dnipropetrovsk | 49027 | Ukraine |
| Donetsk | 83008 | Ukraine |
| Kherson,Vil. Stepanivka | 73488 | Ukraine |
| Kyiv | 02660 | Ukraine |
| Kyiv | 04080 | Ukraine |
| Poltava | 36006 | Ukraine |
| Vinnytsia | 21005 | Ukraine |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C550631 | (4-(3-fluoro-5-trifluoromethylpyridin-2-yl)piperazin-1-yl)(5-methanesulfonyl-2-(2,2,2-trifluoro-1-methylethoxy)phenyl)methanone |
| D000077152 | Olanzapine |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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