Bifeprunox in the Treatment of Schizophrenia

January 15, 2015 updated by: Solvay Pharmaceuticals

A Randomized, Double-Blind, Olanzapine-Referenced, Parallel-Group Safety and Efficacy Study of Flexible Doses of Bifeprunox in the Long-term Treatment of Schizpohrenia (Extension of S1543003)

Study of the long-term efficacy and safety of bifeprunox in the treatment of schizophrenia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • diagnosis of schizophrenia
  • understand nature of study
  • able to be managed in out-patient setting for long-term bifeprunox treatment

Exclusion Criteria:

  • current primary diagnosis other than schizophrenia
  • suicide risk
  • diagnosis or history of substance abuse
  • uncontrolled hypertension

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Solvay Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Primary Completion (ACTUAL)

November 1, 2006

Study Completion (ACTUAL)

November 1, 2006

Study Registration Dates

First Submitted

September 11, 2005

First Submitted That Met QC Criteria

September 11, 2005

First Posted (ESTIMATE)

September 19, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

January 16, 2015

Last Update Submitted That Met QC Criteria

January 15, 2015

Last Verified

January 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S154.3.004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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