drugset / Trial / NCT01234779

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

NCT01234779

Phase 2 Completed 301 enrolled Hoffmann-La Roche
RandomizedParallel-groupDouble-blindTreatment

Summary

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.

Timeline

Start
2011-02
Primary completion
2012-09
Completion
2012-09

Drugs

EvaluationDrugModalityDoseRoute
Comparator Olanzapine Small molecule 15 mg Oral
Subject bitopertin Small molecule 10 mg Oral
Subject bitopertin Small molecule 30 mg Oral

Indications