A Study of RO4917838 (Bitopertin) in Patients With Acute Exacerbation of Schizophrenia
NCT ID: NCT01234779
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
PHASE2
301 participants
INTERVENTIONAL
2011-02-28
2012-09-30
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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A
bitopertin [RO4917838]
10 mg orally daily, 4 weeks
B
bitopertin [RO4917838]
30 mg orally daily, 4 weeks
C
olanzapine
15 mg orally daily, 4 weeks
D
placebo
orally daily, 4 weeks
Interventions
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bitopertin [RO4917838]
10 mg orally daily, 4 weeks
bitopertin [RO4917838]
30 mg orally daily, 4 weeks
olanzapine
15 mg orally daily, 4 weeks
placebo
orally daily, 4 weeks
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of schizophrenia (Diagnostic and Statistical Manual of Mental Disorders DSM IV-TR)
* Acute exacerbation which began within the prior 8 weeks
* Female patients must be surgically sterile or post-menopausal, or agree to use effective contraception for the duration of the study
Exclusion Criteria
* Alcohol or substance dependence within 3 months or abuse within 1 month (except for nicotine)
* Electro-convulsive therapy (ECT) within the prior 6 months
* Previous treatment with RO4917838 or another GLYT inhibitor
* Current treatment with olanzapine, or previous treatment with intolerability or lack of response
* Treatment with long-acting injectable antipsychotic within 2 dosing intervals
* Treatment with \> 2 antipsychotics within 3 months
* History of neuroleptic malignant syndrome
* Have treatment-resistant schizophrenia as judged by treating physician or have failed two trials according to criteria in protocol
18 Years
65 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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Little Rock, Arkansas, United States
Cerritos, California, United States
Oceanside, California, United States
Pico Rivera, California, United States
San Diego, California, United States
Lauderhill, Florida, United States
North Miami, Florida, United States
Atlanta, Georgia, United States
Lake Charles, Louisiana, United States
Flowood, Mississippi, United States
St Louis, Missouri, United States
Willingboro, New Jersey, United States
Holliswood, New York, United States
New York, New York, United States
Cincinnati, Ohio, United States
Philadelphia, Pennsylvania, United States
Charlesston, South Carolina, United States
Austin, Texas, United States
Irving, Texas, United States
Arad, , Romania
Bucharest, , Romania
Bucharest, , Romania
Bucharest, , Romania
Foscani, , Romania
Oradea, , Romania
Târgovişte, , Romania
Gatchina, , Russia
Moscow, , Russia
Petrozavodsk, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Talagi, , Russia
Bojnice, , Slovakia
Bratislava, , Slovakia
Liptovský Mikuláš, , Slovakia
Michalovce, , Slovakia
Dnipropetrovsk, , Ukraine
Donetsk, , Ukraine
Kherson,Vil. Stepanivka, , Ukraine
Kyiv, , Ukraine
Kyiv, , Ukraine
Poltava, , Ukraine
Vinnytsia, , Ukraine
Countries
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Other Identifiers
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2010-021984-33
Identifier Type: -
Identifier Source: secondary_id
WN25333
Identifier Type: -
Identifier Source: org_study_id