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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-020718-26 |
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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 |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| bitopertin [RO4917838] 1 | Experimental |
| |
| bitopertin [RO4917838] 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Oral doses, once a day for 52 weeks |
| |
| bitopertin [RO4917838] level 1 |
| 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 |
|---|---|---|---|---|---|---|
| Costa Mesa | California | 92626 | 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] level 2 | 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 |
| Escondido |
| California |
| 92025 |
| United States |
| Granada Hills | California | 91344 | United States |
| La Jolla | California | 92093 | United States |
| Oceanside | California | 92056 | United States |
| San Diego | California | 92103 | United States |
| Torrance | California | 90502 | United States |
| Lauderhill | Florida | 33319 | United States |
| Orange City | Florida | 3273 | United States |
| Plantation | Florida | 33317 | United States |
| Atlanta | Georgia | 30308 | United States |
| Indianapolis | Indiana | 46222 | United States |
| Flowood | Mississippi | 39232 | United States |
| Las Vegas | Nevada | 89102 | United States |
| Buffalo | New York | 14215 | United States |
| New York | New York | 10032 | United States |
| Rochester | New York | 14618 | United States |
| Durham | North Carolina | 27705 | United States |
| Scranton | Pennsylvania | 18503 | United States |
| Austin | Texas | 78754 | United States |
| Irving | Texas | 75062 | United States |
| Salt Lake City | Utah | 84106 | United States |
| Burgas | 8000 | Bulgaria |
| Kazanlak | 6100 | Bulgaria |
| Novi Iskar | 1282 | Bulgaria |
| Pazardzhik | 4400 | Bulgaria |
| Plovdiv | 4002 | Bulgaria |
| Radnevo | 6260 | Bulgaria |
| Rousse | 7003 | Bulgaria |
| Sofia | 1606 | Bulgaria |
| Baoding | 071000 | China |
| Beijing | 071000 | China |
| Beijing | 100083 | China |
| Beijing | 100088 | China |
| Changsha | 410011 | China |
| Chengdu | 610041 | China |
| GuangzhouGuangdong | 510370 | China |
| Hangzhou | 310003 | China |
| Kunming | 650032 | China |
| Nanjing | 210029 | China |
| Shanghai | 200030 | China |
| Shanghai | 200065 | China |
| Wuhan | 430060 | China |
| Wuxi | 214151 | China |
| Xi'an | 710032 | China |
| Xi'an | 710061 | China |
| Brno | 602 00 | Czechia |
| Liberec | 460 63 | Czechia |
| Mělník | 276 01 | Czechia |
| Pilsen | 312 00 | Czechia |
| Prague | 100 00 | Czechia |
| Prague | 160 00 | Czechia |
| Praha 8 - Bohnice | 181 03 | Czechia |
| Sternberk | 785 01 | Czechia |
| Bari | Apulia | 70124 | Italy |
| Naples | Campania | 80131 | Italy |
| Brescia | Lombardy | 25123 | Italy |
| Milan | Lombardy | 20121 | Italy |
| Milan | Lombardy | 20122 | Italy |
| Turin | Piedmont | 10126 | Italy |
| Pisa | Tuscany | 56124 | Italy |
| Pisa | Tuscany | 56126 | Italy |
| Padova | Veneto | 35128 | Italy |
| Chiba | 272-8516 | Japan |
| Funabashi-shi | 273-8540 | Japan |
| Gunma | 370-2455 | Japan |
| Hiroshima | 733-0864 | Japan |
| Hokkaido | 060-8648 | Japan |
| Kanzaki-gun | 842-0192 | Japan |
| Kita-ku | 114-0024 | Japan |
| Kitakyushu-shi | 807-8556 | Japan |
| Kochi | 780-8535 | Japan |
| Koshi-shi | 861-1116 | Japan |
| Kumamoto | 861-8002 | Japan |
| Kurayoshi-shi | 682-0023 | Japan |
| Nagoya | 463-0802 | Japan |
| Omuta-shi | 836-0004 | Japan |
| Sakaishi | 590-0018 | Japan |
| Sapporo | 004-0841 | Japan |
| Sapporo | 006-0816 | Japan |
| Sendai | 983-0836 | Japan |
| Shirakawa-shi | 961-0021 | Japan |
| Tokyo | 162-8666 | Japan |
| Tokyo | 187-8551 | Japan |
| Toyama | 939-8073 | Japan |
| Toyoake-shi | 470-1192 | Japan |
| Yokohama | 223-0062 | Japan |
| Yokohama | 233-0006 | Japan |
| Yokohama | 246-0026 | Japan |
| Saint Petersburg | 190121 | Russia |
| 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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