Progressively Decreasing Titration Schedules of Bifeprunox in Subjects With Schizophrenia or Bipolar Disorder

January 15, 2015 updated by: Solvay Pharmaceuticals

A Randomized, Double-Blind, Placebo-Controlled, Sequential Panel Study of the Safety and Tolerability of Progressively Decreasing Titration Schedules of Bifeprunox in Subjects With Either Schizophrenia or Bipolar Disorder With an Optional Open-Label 26-Week Extension Study

This study is to assess the tolerability of bifeprunox with the progressive elimination of titration steps to achieve the shortest tolerated titration dosing to a dose of 40 mg/day in either schizophrenia or bipolar disorder subjects. Study duration is 2 months with an optional open-label 26-week extension study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Orange, California, United States
        • Site 1

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 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects with the current Diagnosis of Schizophrenia, Bipolar Type I Disorder according to DSM-IV TR criteria
  • Age 18 to 55
  • Body weight 100-250 lbs
  • Be sufficiently stable to allow discontinuation of antipsychotic medication

Exclusion Criteria:

  • Acutely psychotic subjects
  • Subjects that are acutely manic
  • Subjects with a psych diagnosis other than Bipolar Type I Disorder

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: Single Group Assignment
  • Masking: Double

Collaborators and Investigators

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

Sponsor

Solvay Pharmaceuticals

Collaborators

Wyeth is now a wholly owned subsidiary of Pfizer
H. Lundbeck A/S

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

January 1, 2006

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

August 30, 2005

First Submitted That Met QC Criteria

August 30, 2005

First Posted (Estimate)

August 31, 2005

Study Record Updates

Last Update Posted (Estimate)

January 16, 2015

Last Update Submitted That Met QC Criteria

January 15, 2015

Last Verified

November 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S154.2.017

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.

Clinical Trials on Schizophrenia

Clinical Trials on Bifeprunox

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Morocco

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe