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

NCT01234779 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 301

Last updated 2016-11-02

No results posted yet for this study

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.

Conditions

Interventions

DRUG

bitopertin [RO4917838]

10 mg orally daily, 4 weeks

DRUG

bitopertin [RO4917838]

30 mg orally daily, 4 weeks

DRUG

olanzapine

15 mg orally daily, 4 weeks

DRUG

placebo

orally daily, 4 weeks

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • United States
  • Romania
  • Russia
  • Slovakia
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01234779 on ClinicalTrials.gov