To Evaluate the Impact of Treatment Interruption on Re-initiation of Bifeprunox

A Single-center Safety and Tolerability Study to Evaluate the Impact of Treatment Interruption on Re-initiation of Bifeprunox in Subjects With Schizophrenia or Schizoaffective Disorder

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00141479

Enrollment

Unknown

Registered

2005-09-01

Start date

2005-05-31

Completion date

2006-11-30

Last updated

2015-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizoaffective Disorder, Schizophrenia

Keywords

Treatment interruption on reinitiation, Schizophrenia, Schizoaffective disorder

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.

Interventions

DRUGBifeprunox

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Inclusion criteria

* Diagnosis of Schizophrenia or Schizoaffective disorder * 18-55 years

Exclusion criteria

* 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026