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

Roche

Status and phase

Completed

Phase 2

Conditions

Schizophrenia

Treatments

Drug: olanzapine

Drug: placebo

Drug: bitopertin [RO4917838]

Study type

Interventional

Funder types

Industry

Identifiers

NCT01234779

2010-021984-33

WN25333

Details and patient eligibility

About

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.

Enrollment

301 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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