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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-020696-23 |
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This randomized, multi-center, double-blind, parallel-group, placebo-controlled study will evaluate the efficacy and safety of RO4917838 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 |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
| |
| 3 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Oral doses, once a day for 52 weeks |
| |
| 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 |
|---|---|---|---|---|---|---|
| Little Rock | Arkansas | 72201 | 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 |
|
| 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 |
| Little Rock |
| Arkansas |
| 72211 |
| United States |
| Buena Park | California | 90620 | United States |
| Cerritos | California | 90703 | United States |
| Downey | California | 90241 | United States |
| La Palma | California | 90623 | United States |
| Pasadena | California | 91106 | United States |
| Pico Rivera | California | 90660 | United States |
| Miami | Florida | 33126 | United States |
| Miami | Florida | 33136 | United States |
| Marietta | Georgia | 30060 | United States |
| Oak Brook | Illinois | 60523 | United States |
| Iowa City | Iowa | 52242 | United States |
| Glen Burnie | Maryland | 21061 | United States |
| Las Vegas | Nevada | 89102 | United States |
| Toms River | New Jersey | 08775 | United States |
| Willingboro | New Jersey | 08046 | United States |
| Albuquerque | New Mexico | 87108 | United States |
| Brooklyn | New York | 11201 | United States |
| Fresh Meadows | New York | 11366 | United States |
| New York | New York | 10035 | United States |
| Raleigh | North Carolina | 27603 | United States |
| Cincinnati | Ohio | 45206 | United States |
| Philadelphia | Pennsylvania | 19131 | United States |
| Scranton | Pennsylvania | 18503 | United States |
| Bellaire | Texas | 77401 | United States |
| Dallas | Texas | 75231 | United States |
| Dallas | Texas | 75243 | United States |
| The Woodlands | Texas | 77381 | United States |
| Kirkland | Washington | 98033 | United States |
| Buenos Aires | 1425 | Argentina |
| Buenos Aires | C1425AHQ | Argentina |
| Ciudad Autonoma Bs As | 1117 | Argentina |
| Ciudad Autonoma Bs As | 1405 | Argentina |
| Córdoba | 5003 | Argentina |
| Córdoba | X5009BIN | Argentina |
| La Plata | 1900 | Argentina |
| Mendoza | 5500 | Argentina |
| Rosario | S2000QJI | Argentina |
| Santiago del Estero | 4200 | Argentina |
| Westmead | New South Wales | 2145 | Australia |
| Clayton | Victoria | 3168 | Australia |
| Frankston | Victoria | 3199 | Australia |
| Melbourne | Victoria | 3004 | Australia |
| Barranquilla | Colombia |
| Bello | Colombia |
| Bogotá | Colombia |
| Helsinki | 00250 | Finland |
| Kuopio | 70100 | Finland |
| Clermont-Ferrand | 63000 | France |
| Dole | 39100 | France |
| Élancourt | 78990 | France |
| Marseille | 13005 | France |
| Strasbourg | 67091 | France |
| Toulon | 83000 | France |
| Balassagyarmat | 2660 | Hungary |
| Budapest | 1032 | Hungary |
| Budapest | 1082 | Hungary |
| Budapest | 1135 | Hungary |
| Győr | 9024 | Hungary |
| Gyula | 5700 | Hungary |
| Ahmedabad | 380006 | India |
| Ahmedabad | 380008 | India |
| Ahmedabad | 380015 | India |
| Bangalore | 560054 | India |
| Jaipur | 302017 | India |
| Jaipur | 302021 | India |
| Kalyān | 421301 | India |
| Mangalore | 575001 | India |
| Mangalore | 575018 | India |
| Nashik | 422101 | India |
| Pune | 411030 | India |
| Vadodara | 390001 | India |
| México | 05300 | Mexico |
| Monterrey | 64000 | Mexico |
| Monterrey | 64060 | Mexico |
| Monterrey | 64710 | Mexico |
| San Luis Potosí City | 72818 | Mexico |
| Arad | 310022 | Romania |
| Bucharest | 010825 | Romania |
| Bucharest | 041914 | Romania |
| Cluj-Napoca | 400012 | Romania |
| Lasi | 700282 | Romania |
| Oradea | 410154 | Romania |
| Sibiu | 550082 | Romania |
| Targouiste | 130081 | Romania |
| Kemerovo | 650036 | Russia |
| Lipetsk | 399313 | Russia |
| Moscow | 107076 | Russia |
| Moscow | 115522 | Russia |
| Moscow | 117995 | Russia |
| Moscow | 127083 | Russia |
| Moscow Region | 142601 | Russia |
| Nizhny Novgorod | 603155 | Russia |
| Saint Petersburg | 190005 | Russia |
| Saint Petersburg | 190121 | Russia |
| Saint Petersburg | 192019 | Russia |
| Saint Petersburg | 193167 | Russia |
| Saint Petersburg | 194044 | Russia |
| Saint Petersburg | 197341 | Russia |
| Samara | 443016 | Russia |
| Sartatov | 410028 | Russia |
| Talagi | 163530 | Russia |
| Tomsk | 634014 | Russia |
| Busan | 614-735 | South Korea |
| Gwangju | 501-757 | South Korea |
| Gyeonggi-do | 425-707 | South Korea |
| Incheon | 400-711 | South Korea |
| Incheon | 405-760 | South Korea |
| Jeollabuk-do | 561-712 | South Korea |
| Seoul | 110-774 | South Korea |
| Seoul | 136-705 | South Korea |
| Seoul | 150-713 | South Korea |
| Malmö | 21135 | Sweden |
| Stockholm | 14186 | Sweden |
| Stockholm | 18288 | Sweden |
| Uppsala | 75185 | Sweden |
| Edinburgh | EH10 5HF | United Kingdom |
| London | SE5-8AF | United Kingdom |
| London | W12 0HS | United Kingdom |
| Oxford | OX3 7JX | United Kingdom |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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