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NCT01192880 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study, sponsored by Hoffmann-La Roche.

Completed
Registry status
Phase 3
Development phase
625
Enrollment target

NCT01192880 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 625 participants.

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The verdict

NCT01192880, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.

COMPLETED
Registry status
Phase 3
Development phase
625 participants
Enrollment target

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.

Interventions

  • DRUG Placebo
  • DRUG Antipsychotics
  • DRUG Bitopertin

Trial Details

FieldValue
Enrollment Target 625 participants
Start Date 2010-11
Est. Completion 2014-07
Phase Phase 3

Sponsor

Hoffmann-La Roche

909 total trials

What the Registry Record Tells You About NCT01192880

The ClinicalTrials.gov registry entry for NCT01192880 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 625 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT01192880 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01192880 about?

NCT01192880 is a clinical study titled "A Study to Evaluate Efficacy and Safety of Bitopertin in Participants With Persistent, Predominant Negative Symptoms of Schizophrenia". 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 ...

What is the current status of trial NCT01192880?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 625 participants. The study started on 2010-11. Estimated completion is 2014-07.

What interventions are being tested in trial NCT01192880?

The interventions under investigation include: Placebo (DRUG), Antipsychotics (DRUG), Bitopertin (DRUG).

Who is sponsoring clinical trial NCT01192880?

This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.