drugset / Trial / NCT00616798

A Study of RO4917838 in Combination With Antipsychotic Treatment in Patients With Schizophrenia.

NCT00616798

Phase 2 Completed 323 enrolled Hoffmann-La Roche
RandomizedParallel-groupDouble-blindTreatment

Summary

This study will determine the efficacy and safety of RO4917838 in patients with schizophrenia who are stable on current antipsychotic treatment (olanzapine, que tiapine, risperidone, paliperidone or aripiprazole) with prominent negative or d isorganized thought symptoms. After a 4 week run in period on their current anti psychotic treatment, patients will be randomized to receive placebo 10mg, 30mg, or 60mg of RO4917838 once daily, p.o., as add-on therapy. The anticipated time o n study treatment is \<3 months, and the target sample size is 100-500 individual s.

Timeline

Start
2008-03
Primary completion
2010-02
Completion
2010-02

Drugs

EvaluationDrugModalityDoseRoute
Subject bitopertin Small molecule 10 mg Oral
Subject bitopertin Small molecule 30 mg Oral
Subject bitopertin Small molecule 60 mg Oral

Indications