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NCT01192906 · ClinicalTrials.gov registry record · Phase 3

A Study of RO4917838 (Bitopertin) in Patients With Persistent, Predominant Negative Symptoms of Schizophrenia (WN25309)

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

Completed
Registry status
Phase 3
Development phase
624
Enrollment target
20
Study locations

NCT01192906: Completed Phase 3 study of Schizophrenia, sponsored by Hoffmann-La Roche.

NCT01192906 is a Phase 3 study of Schizophrenia that has completed, run by Hoffmann-La Roche. The registered enrollment target is 624 participants, above the 217-participant average among 315 other Schizophrenia trials with a reported enrollment target (188% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01192906, a Phase 3 study of Schizophrenia, has completed, sponsored by Hoffmann-La Roche.

COMPLETED
Registry status
Phase 3
Development phase
624 participants
Enrollment target
20
Study locations

Study Summary

This multi-center, randomized, double blind, parallel-group, placebo-controlled study will evaluate the efficacy and safety of RO4917838 (bitopertin) in patients with persistent, predominant negative symptoms of schizophrenia. Patients, 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 Studied

Interventions

  • DRUG Placebo
  • DRUG bitopertin [RO4917838]

Study Locations (20)

California

  • - Carson
  • - Oceanside
  • - San Diego
  • - San Diego

Illinois

  • - Chicago
  • - Hoffman Estates
  • - Joliet

New York

  • - Cedarhurst
  • - Jamaica
  • - Rochester

Connecticut

  • - Hartford
  • - Norwalk

Louisiana

  • - Lake Charles
  • - Shreveport

Pennsylvania

  • - Allentown
  • - Norristown

Florida

  • - North Miami

Georgia

  • - Atlanta

Trial Details

FieldValue
Enrollment Target 624 participants
Start Date 2010-12
Est. Completion 2014-07
Phase Phase 3
Hoffmann-La Roche

909 total trials

What the finished NCT01192906 record still lists

NCT01192906 is an interventional study that assigns participants to a tested intervention. The registered 624 participants enrollment target is mid-sized for trials with a published cap, above the 217-participant average among 315 other Schizophrenia trials with a reported enrollment target (188% higher).

The record links to 1 condition, with Schizophrenia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT01192906 names 20 study sites across 10 states, led by California, Illinois, New York.

Frequently Asked Questions

What is clinical trial NCT01192906 about?

NCT01192906 is a clinical study titled "A Study of RO4917838 (Bitopertin) in Patients With Persistent, Predominant Negative Symptoms of Schizophrenia (WN25309)". This multi-center, randomized, double blind, parallel-group, placebo-controlled study will evaluate the efficacy and safety of RO4917838 (bitopertin) in patients with persistent, predominant negative symptoms of schizophrenia. Patients, on stable treatment with antipsychotics, will be randomized to ...

What is the current status of trial NCT01192906?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 624 participants. The study started on 2010-12. Estimated completion is 2014-07.

What conditions does trial NCT01192906 study?

This clinical trial studies the following conditions: Schizophrenia.

What interventions are being tested in trial NCT01192906?

The interventions under investigation include: Placebo (DRUG), bitopertin [RO4917838] (DRUG).

Who is sponsoring clinical trial NCT01192906?

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

Where is trial NCT01192906 being conducted?

This trial has 20 study locations across California, Connecticut, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Schizophrenia

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01192906's enrollment target sits among peer trials

624 25th of 315 higher than 291 of 315 other Schizophrenia trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Schizophrenia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01192906, the US trial registry maintained by the National Library of Medicine. NCT01192906 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.