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This study will determine the efficacy and safety of RO4917838 in patients with schizophrenia who are stable on current antipsychotic treatment (olanzapine, que tiapine, risperidone, paliperidone or aripiprazole) with prominent negative or d isorganized thought symptoms. After a 4 week run in period on their current anti psychotic treatment, patients will be randomized to receive placebo 10mg, 30mg, or 60mg of RO4917838 once daily, p.o., as add-on therapy. The anticipated time o n study treatment is <3 months, and the target sample size is 100-500 individual s.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3 | Experimental |
| |
| 4 | Placebo Comparator |
| |
| 1 | Experimental |
| |
| 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RO4917838 | Drug | 10mg po daily |
| |
| RO4917838 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline in PANSS (Positive and Negative Syndrome Scale) negative factor score. | Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in total PANSS score, CGI, PSP, SGLS; cognition status changes. | Throughout study | |
| AEs, laboratory parameters, C-SSRS | Throughout study |
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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 |
|---|---|---|---|---|---|---|
| Granada Hills | California | 91344 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24696094 | Derived | Umbricht D, Alberati D, Martin-Facklam M, Borroni E, Youssef EA, Ostland M, Wallace TL, Knoflach F, Dorflinger E, Wettstein JG, Bausch A, Garibaldi G, Santarelli L. Effect of bitopertin, a glycine reuptake inhibitor, on negative symptoms of schizophrenia: a randomized, double-blind, proof-of-concept study. JAMA Psychiatry. 2014 Jun;71(6):637-46. doi: 10.1001/jamapsychiatry.2014.163. |
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| Drug |
30mg po daily |
|
| RO4917838 | Drug | 60mg po daily |
|
| Placebo | Drug | po daily |
|
| Standard antipsychotic therapy | Drug | As prescribed |
|
| Los Angeles |
| California |
| 90033 |
| United States |
| Oceanside | California | 92056 | United States |
| Torrance | California | 90502 | United States |
| Atlanta | Georgia | 30308 | United States |
| Hoffman Estates | Illinois | 60169 | United States |
| Brooklyn | New York | 11203 | United States |
| Cincinnati | Ohio | 45267 | United States |
| Oklahoma City | Oklahoma | 73103 | United States |
| Philadelphia | Pennsylvania | 19139 | United States |
| Austin | Texas | 78754 | United States |
| Austin | Texas | 78756 | United States |
| DeSoto | Texas | 75115 | United States |
| Irving | Texas | 75062 | United States |
| Vienna | 1010 | Austria |
| Vienna | 1090 | Austria |
| Curitiba | 80520-000 | Brazil |
| Pelotas | 96030-002 | Brazil |
| Rio de Janeiro | 21020-130 | Brazil |
| Salvador | 40301-500 | Brazil |
| São Paulo | 04044-000 | Brazil |
| São Paulo | 05403-010 | Brazil |
| Marseille | 13009 | France |
| Orvault | 44700 | France |
| Toulon | 83056 | France |
| Achim | 28832 | Germany |
| Bochum | 44805 | Germany |
| Freiburg im Breisgau | 79104 | Germany |
| Hamburg | 20246 | Germany |
| Nuremberg | 90402 | Germany |
| Westerstede | 26655 | Germany |
| Balassagyarmat | 2660 | Hungary |
| Budapest | 1083 | Hungary |
| Budapest | 1097 | Hungary |
| Budapest | 1125 | Hungary |
| Budapest | 1135 | Hungary |
| GYR | 9024 | Hungary |
| Gyula | 5700 | Hungary |
| Nyíregyháza | 4400 | Hungary |
| Aichi | 470-1192 | Japan |
| Chiba | 272-8516 | Japan |
| Fukuoka | 807-8555 | Japan |
| Fukuoka | 812-8582 | Japan |
| Gunma | 373-0054 | Japan |
| Kanagawa | 232-0024 | Japan |
| Kanagawa | 236-0004 | Japan |
| Nagasaki | 852-8501 | Japan |
| Saga | 842-0192 | Japan |
| Sapporo | 060-8638 | Japan |
| Tokushima | 770-8503 | Japan |
| Tokyo | 162-8666 | Japan |
| Tokyo | 187-8551 | Japan |
| Mexico City | 06100 | Mexico |
| Mexico City | 11560 | Mexico |
| Mexico City | 1400 | Mexico |
| Mexico City | 14370 | Mexico |
| Monterrey | 64710 | Mexico |
| Bydgoszcz | 85-096 | Poland |
| Kielce | 25-317 | Poland |
| Skorzewo | 60-165 | Poland |
| Torun | 87-100 | Poland |
| Tuszyn | 95-080 | Poland |
| Żuromin | 09-300 | Poland |
| Kazan' | 420012 | Russia |
| Lipetsk | 399313 | Russia |
| Moscow | 115522 | Russia |
| Moscow | 117152 | Russia |
| Moscow | 123367 | Russia |
| Nizhny Novgorod | 603155 | Russia |
| Saint Petersburg | 190005 | Russia |
| Saint Petersburg | 192019 | Russia |
| Saint Petersburg | 193019 | Russia |
| Saint Petersburg | 193167 | Russia |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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