A Study of RO4917838 (Bitopertin) in Patients With Acute Exacerbation of Schizophrenia

Completed · Phase 2 · Has a placebo group

Conditions studied: Schizophrenia

In brief

This randomized, double-blind, placebo- and active-controlled, parallel group study will evaluate the safety and efficacy of RO4917838 (bitopertin) in patients with acute exacerbation of schizophrenia. Patients will be randomized to receive either RO4917838 10 mg or RO4917838 30 mg or olanzapine 15 mg or placebo orally daily for 4 weeks as inpatients, with a 4-week follow-up period.

Key facts

Study ID

NCT01234779

Run by

Hoffmann-La Roche

People needed

301

Starts

2011-02-01

Expected to finish

2012-09-01

Last updated by the study team

2016-11-02

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult patients, 18-65 years of age
• 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

You may not qualify if…

• Current psychiatric diagnosis other than schizophrenia
• 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

Where it is running

• Study site — Little Rock, Arkansas, United States
• Study site — Cerritos, California, United States
• Study site — Oceanside, California, United States
• Study site — Pico Rivera, California, United States
• Study site — San Diego, California, United States
• Study site — Lauderhill, Florida, United States
• Study site — North Miami, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Lake Charles, Louisiana, United States
• Study site — Flowood, Mississippi, United States
• Study site — St Louis, Missouri, United States
• Study site — Willingboro, New Jersey, United States
• Study site — Holliswood, New York, United States
• Study site — New York, New York, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Charlesston, South Carolina, United States
• Study site — Austin, Texas, United States
• Study site — Irving, Texas, United States
• Study site — Arad, Romania
• Study site — Bucharest, Romania
• Study site — Bucharest, Romania
• Study site — Bucharest, Romania
• Study site — Foscani, Romania
• Study site — Oradea, Romania

Full record on ClinicalTrials.gov

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