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

Hoffmann-La Roche301 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

301

Conditions

Schizophrenia

Interventions

bitopertin [RO4917838]DRUG

10 mg orally daily, 4 weeks

bitopertin [RO4917838]DRUG

30 mg orally daily, 4 weeks

olanzapineDRUG

15 mg orally daily, 4 weeks

placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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