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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-020616-11 |
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This randomized, multi-center, double-blind, parallel-group, placebo-controlled study will evaluate the efficacy and safety of RO4917838 (bitopertin) in patients with sub-optimally controlled symptoms of schizophrenia. Patients, on stable treatment with antipsychotics, will be randomized to receive daily oral doses of RO4917838 or matching placebo for 52 weeks, followed by an optional treatment extension for up to 3 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bitopertin oral dose level 1 | Experimental |
| |
| Bitopertin oral dose level 2 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Oral doses, once a day for 52 weeks |
| |
| bitopertin [RO4917838] |
| Measure | Description | Time Frame |
|---|---|---|
| Positive symptoms factor score assessed by Positive and Negative Syndrome Scale (PANSS) | Change from baseline to Week 12 | |
| Safety (incidence of adverse events) | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Symptom domains of schizophrenia using Positive and Negative Syndrome Scale (PANSS) | Change from baseline to Week 12 | |
| Disease improvement on Clinical Global Impression - Improvement (CGI-I) symptoms scale | Change from baseline to Week 12 |
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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 |
|---|---|---|---|---|---|---|
| Carson | California | 90746 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27816567 | Derived | Bugarski-Kirola D, Iwata N, Sameljak S, Reid C, Blaettler T, Millar L, Marques TR, Garibaldi G, Kapur S. Efficacy and safety of adjunctive bitopertin versus placebo in patients with suboptimally controlled symptoms of schizophrenia treated with antipsychotics: results from three phase 3, randomised, double-blind, parallel-group, placebo-controlled, multicentre studies in the SearchLyte clinical trial programme. Lancet Psychiatry. 2016 Dec;3(12):1115-1128. doi: 10.1016/S2215-0366(16)30344-3. Epub 2016 Nov 2. |
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| Drug |
Oral dose level 1, once a day for 52 weeks |
|
| bitopertin [RO4917838] | Drug | Oral dose level 2, once a day for 52 weeks |
|
| Disease severity on Clinical Global Impression - Severity (CGI-S) symptoms scale | Change from baseline to Week 12 |
| Safety (incidence of adverse events) | 60 weeks |
| Garden Grove |
| California |
| 92845 |
| United States |
| Long Beach | California | 90813 | United States |
| Long Beach | California | 90822 | United States |
| Oceanside | California | 92056 | United States |
| San Diego | California | 92121 | United States |
| San Diego | California | 92123 | United States |
| Hartford | Connecticut | 06106 | United States |
| Norwalk | Connecticut | 06851 | United States |
| North Miami | Florida | 33161 | United States |
| Atlanta | Georgia | 30328 | United States |
| Chicago | Illinois | 60612 | United States |
| Hoffman Estates | Illinois | 60169 | United States |
| Joliet | Illinois | 60435 | United States |
| Lake Charles | Louisiana | 70601 | United States |
| St Louis | Missouri | 63128 | United States |
| St Louis | Missouri | 63141 | United States |
| Omahac | Nebraska | 68131 | United States |
| Cedarhurst | New York | 11516 | United States |
| Jamaica | New York | 11418 | United States |
| Rochester | New York | 14623 | United States |
| Allentown | Pennsylvania | 18104 | United States |
| Norristown | Pennsylvania | 19403 | United States |
| Philadelphia | Pennsylvania | 19139 | United States |
| Bothell | Washington | 98011 | United States |
| Salvador | Estado de Bahia | 40301-500 | Brazil |
| Goiânia | Goiás | 74093-040 | Brazil |
| Belo Horizonte | Minas Gerais | 30150-270 | Brazil |
| Curitiba | Paraná | 80240-280 | Brazil |
| Rio de Janeiro | Rio de Janeiro | 22270-060 | Brazil |
| Pelotas | Rio Grande do Sul | 96030-002 | Brazil |
| Porto Alegre | Rio Grande do Sul | 90035-003 | Brazil |
| Itapira | São Paulo | 13970-905 | Brazil |
| São Paulo | São Paulo | 04044-000 | Brazil |
| São Paulo | São Paulo | 05403-010 | Brazil |
| Calgary | Alberta | T2N 4Z6 | Canada |
| Medicine Hat | Alberta | T1B 4E7 | Canada |
| Vancouver | British Columbia | V5Z 3P1 | Canada |
| Halifax | Nova Scotia | B3H 2E2 | Canada |
| Burlington | Ontario | L7R 4E2 | Canada |
| Hamilton | Ontario | L8N 3K7 | Canada |
| Mississauga | Ontario | L5M 4N4 | Canada |
| Montreal | Quebec | H1N 3M5 | Canada |
| Montreal | Quebec | H3A 1A1 | Canada |
| Santiago | 7500710 | Chile |
| Santiago | 7501126 | Chile |
| Santiago | 8050000 | Chile |
| Santiago | 8320000 | Chile |
| Santiago | 8900000 | Chile |
| Santiago | Chile |
| Valdivia | 5090000 | Chile |
| Berlin | 10117 | Germany |
| Bochum | 44805 | Germany |
| Cologne | 50937 | Germany |
| Freiburg im Breisgau | 79104 | Germany |
| Hamburg | 20246 | Germany |
| München | 80336 | Germany |
| München | 81675 | Germany |
| Nuremberg | 90402 | Germany |
| Daugovpils | LV-5417 | Latvia |
| Jelgava | LV-3008 | Latvia |
| Liepāja | LV 3401 | Latvia |
| Kaunas | 44279 | Lithuania |
| Kaunas | 48259 | Lithuania |
| Kaunas | 50009 | Lithuania |
| Kaunas | 53136 | Lithuania |
| Šilutė | 99142 | Lithuania |
| Vilnius | 07156 | Lithuania |
| Vilnius | 10204 | Lithuania |
| Assen | 9400 RA | Netherlands |
| Groningen | 9700 AB | Netherlands |
| Groningen | 9713 GZ | Netherlands |
| Choroszcz | 16-070 | Poland |
| Kielce | 25-103 | Poland |
| Lublin | 20-045 | Poland |
| Lublin | 20-080 | Poland |
| Lublin | 20-582 | Poland |
| Piekary Śląskie | 41-940 | Poland |
| Skorzewo | 60-185 | Poland |
| Tuszyn | 95-080 | Poland |
| Warsaw | 02-957 | Poland |
| Bojnice | 972 01 | Slovakia |
| Bratislava | 820 07 | Slovakia |
| Bratislava | 851 01 | Slovakia |
| Rimavská Sobota | 97912 | Slovakia |
| Svidník | 089 01 | Slovakia |
| Trnava | 917 75 | Slovakia |
| Barcelona | Barcelona | 08036 | Spain |
| Barcelona | Barcelona | 08304 | Spain |
| Barcelona | Barcelona | 08830 | Spain |
| Madrid | Madrid | 28009 | Spain |
| Madrid | Madrid | 28040 | Spain |
| Oviedo | Principality of Asturias | 33011 | Spain |
| Salamanca | Salamanca | 37007 | Spain |
| Zamora | Zamora | 49021 | Spain |
| Hualian Town | 970 | Taiwan |
| Kaohsiung City | 80276 | Taiwan |
| Taichung | 407 | Taiwan |
| Tainan | 704 | Taiwan |
| Tainan County | 717 | Taiwan |
| Taipei | 00112 | Taiwan |
| Taipei | 110 | Taiwan |
| Ankara | 06100 | Turkey (Türkiye) |
| Diyarbakır | 21280 | Turkey (Türkiye) |
| Gaziantep | 27310 | Turkey (Türkiye) |
| Istanbul | 34000 | Turkey (Türkiye) |
| Istanbul | 34390 | Turkey (Türkiye) |
| Istanbul | 34736 | Turkey (Türkiye) |
| Kocaeli | 41380 | Turkey (Türkiye) |
| Manisa | 45030 | Turkey (Türkiye) |
| Mersin | 33169 | Turkey (Türkiye) |
| Dnipropetrovsk | 49005 | Ukraine |
| Donetsk | 83008 | Ukraine |
| Glevakha Kyviv Region | 08631 | Ukraine |
| Kharkiv | 61068 | Ukraine |
| Kyiv | 02660 | Ukraine |
| Kyiv | 04080 | Ukraine |
| Lviv | 79021 | Ukraine |
| Odesa | 65117 | 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 |
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