NCT00141479

Brief Summary

The purpose of this study is to investigate a safe treatment interruption interval(s) for re-initiation of bifeprunox at a therapeutic dose. The study duration is approximately 7 to 10 weeks.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started May 2005

Geographic Reach
1 country

1 active site

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

August 30, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 1, 2005

Completed
1.2 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

May 1, 2006

Enrollment Period

1.5 years

First QC Date

August 30, 2005

Last Update Submit

January 15, 2015

Conditions

SchizophreniaSchizoaffective Disorder

Keywords

Treatment interruption on reinitiationSchizophreniaSchizoaffective disorder

Interventions

BifeprunoxDRUG

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosis of Schizophrenia or Schizoaffective disorder
  • years

You may not qualify if:

  • Subjects who are acutely psychotic
  • Subjects with current Axis I primary psychiatric diagnosis other than schizophrenia
  • Subjects at significant risk of suicide
  • Subjects with a seizure disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Site 1

Wichita, Kansas, United States

Location

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

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 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 30, 2005

First Posted

September 1, 2005

Study Start

May 1, 2005

Primary Completion

November 1, 2006

Study Completion

November 1, 2006

Last Updated

January 16, 2015

Record last verified: 2006-05

Locations

US(1)