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A Study to Evaluate Efficacy and Safety of Bitopertin in Participants With Persistent, Predominant Negative Symptoms of Schizophrenia

NCT01192880 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 625

Last updated 2017-02-15

No results posted yet for this study

Summary

This Phase 3, multi-center, randomized, double blind, parallel-group, placebo-controlled study will evaluate the efficacy and safety of RO4917838 (bitopertin) in participants with persistent, predominant negative symptoms of schizophrenia. Participants, on stable treatment with antipsychotics, will be randomized to receive daily oral doses of RO4917838 or matching placebo for 52 weeks, followed by an optional treatment extension for up to 3 years.

Conditions

  • Schizophrenia

Interventions

DRUG

Placebo

Participants will receive bitopertin matching placebo once daily for 56 weeks.

DRUG

Bitopertin

Participants will receive 10 mg or 20 mg of bitopertin.

DRUG

Antipsychotics

Participants will continue to receive their stable antipsychotic regiment throughout the study. Study protocol does not specify any particular antipsychotic drug and regimen.

Sponsors & Collaborators

  • Hoffmann-La Roche

    lead INDUSTRY

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • United States
  • Bulgaria
  • China
  • Czechia
  • Italy
  • Japan
  • Russia

Study Locations

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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 NCT01192880 on ClinicalTrials.gov