NCT00193687

Brief Summary

Study of the long-term efficacy and safety of bifeprunox in the treatment of schizophrenia. Extension to study S154.3.001.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
986

participants targeted

Target at P75+ for phase_3 schizophrenia

Timeline
Completed

Started Sep 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

September 1, 2005

Completed
10 days 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
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

March 24, 2008

Status Verified

March 1, 2008

Enrollment Period

2.3 years

First QC Date

September 11, 2005

Last Update Submit

March 20, 2008

Conditions

Schizophrenia

Keywords

open-label 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
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 11, 2005

First Posted

September 19, 2005

Study Start

September 1, 2005

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

March 24, 2008

Record last verified: 2008-03