A Study of RO4917838 (Bitopertin) in Patients With Sub-optimally Controlled Symptoms of Schizophrenia (WN25305)
NCT ID: NCT01235559
Last Updated: 2016-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
604 participants
INTERVENTIONAL
2010-12-31
2015-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
Placebo
Oral doses, once a day for 52 weeks
bitopertin [RO4917838] 1
bitopertin [RO4917838] level 1
Oral dose level 1, once a day for 52 weeks
bitopertin [RO4917838] 2
bitopertin [RO4917838] level 2
Oral dose level 2, once a day for 52 weeks
Interventions
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Placebo
Oral doses, once a day for 52 weeks
bitopertin [RO4917838] level 1
Oral dose level 1, once a day for 52 weeks
bitopertin [RO4917838] level 2
Oral dose level 2, once a day for 52 weeks
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of schizophrenia
* Clinical stability for 16 weeks (4 months) prior to randomization
* Antipsychotic treatment stability for the past 12 weeks prior to randomization
* With the exception of clozapine, patients are on any of the available marketed atypical or typical antipsychotic (treatment with a maximum of two antipsychotics)
Exclusion Criteria
* Evidence that patient has clinically significant uncontrolled or unstable medical disorder (e.g. cardiovascular, renal hepatic, gastrointestinal, hematologic, immunological, neurological, endocrine, metabolic or pulmonary disease)
* Patient has a body mass index (BMI) of \<17 or \>40 kg/m2, respectively)
* Diagnosis of mental retardation or severe organic brain syndromes
* In the investigator's judgment, a significant risk of suicide or violent behavior"
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Costa Mesa, California, United States
Escondido, California, United States
Granada Hills, California, United States
La Jolla, California, United States
Oceanside, California, United States
San Diego, California, United States
Torrance, California, United States
Lauderhill, Florida, United States
Orange City, Florida, United States
Plantation, Florida, United States
Atlanta, Georgia, United States
Indianapolis, Indiana, United States
Flowood, Mississippi, United States
Las Vegas, Nevada, United States
Buffalo, New York, United States
New York, New York, United States
Rochester, New York, United States
Durham, North Carolina, United States
Scranton, Pennsylvania, United States
Austin, Texas, United States
Irving, Texas, United States
Salt Lake City, Utah, United States
Burgas, , Bulgaria
Kazanlak, , Bulgaria
Novi Iskar, , Bulgaria
Pazardzhik, , Bulgaria
Plovdiv, , Bulgaria
Radnevo, , Bulgaria
Rousse, , Bulgaria
Sofia, , Bulgaria
Baoding, , China
Beijing, , China
Beijing, , China
Beijing, , China
Changsha, , China
Chengdu, , China
GuangzhouGuangdong, , China
Hangzhou, , China
Kunming, , China
Nanjing, , China
Shanghai, , China
Shanghai, , China
Wuhan, , China
Wuxi, , China
Xi'an, , China
Xi'an, , China
Brno, , Czechia
Liberec, , Czechia
Mělník, , Czechia
Pilsen, , Czechia
Prague, , Czechia
Prague, , Czechia
Praha 8 - Bohnice, , Czechia
Sternberk, , Czechia
Bari, Apulia, Italy
Napoli, Campania, Italy
Brescia, Lombardy, Italy
Milan, Lombardy, Italy
Milan, Lombardy, Italy
Turin, Piedmont, Italy
Pisa, Tuscany, Italy
Pisa, Tuscany, Italy
Padua, Veneto, Italy
Chiba, , Japan
Funabashi-shi, , Japan
Gunma, , Japan
Hiroshima, , Japan
Hokkaido, , Japan
Kanzaki-gun, , Japan
Kita-ku, , Japan
Kitakyushu-shi, , Japan
Kochi, , Japan
Koshi-shi, , Japan
Kumamoto, , Japan
Kurayoshi-shi, , Japan
Nagoya, , Japan
Omuta-shi, , Japan
Sakaishi, , Japan
Sapporo, , Japan
Sapporo, , Japan
Sendai, , Japan
Shirakawa-shi, , Japan
Tokyo, , Japan
Tokyo, , Japan
Toyama, , Japan
Toyoake-shi, , Japan
Yokohama, , Japan
Yokohama, , Japan
Yokohama, , Japan
Saint Petersburg, , Russia
Countries
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References
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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.
Other Identifiers
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2010-020718-26
Identifier Type: -
Identifier Source: secondary_id
WN25305
Identifier Type: -
Identifier Source: org_study_id