NCT00193713

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started May 2005

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 11, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
Last Updated

January 16, 2015

Status Verified

January 1, 2007

Enrollment Period

1.5 years

First QC Date

September 11, 2005

Last Update Submit

January 15, 2015

Conditions

Schizophrenia

Keywords

double-blind study in the treatment of schizophrenia

Interventions

bifeprunoxDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Schizophrenia

Interventions

bifeprunox

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Global Clinical Director Solvay

    Solvay Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 11, 2005

First Posted

September 19, 2005

Study Start

May 1, 2005

Primary Completion

November 1, 2006

Study Completion

November 1, 2006

Last Updated

January 16, 2015

Record last verified: 2007-01