Twice Daily Titration Study of Bifeprunox in Subjects With Schizophrenia

A Randomized, Double-Blind, Placebo-Controlled, Twice Daily Titration Study of the Safety and Tolerability of Bifeprunox in Subjects With Schizophrenia

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00139906

Enrollment

Unknown

Registered

2005-08-31

Start date

2005-08-31

Completion date

2006-10-31

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

Titration Study, Schizophrenia, BID dosing, Pharmacokinetic

Brief summary

This study is to assess the safety and tolerability of a five-day titration schedule (using twice daily dosing for the first three days) to achieve the highest proposed dose of 40 mg daily. The study duration is two months.

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

* Subjects who have current diagnosis of Schizophrenia or Schizoaffective disorder * Body weight of 100-250 lbs * Male or females * 18-55 years of age

Exclusion criteria

* Subjects who are acutely psychotic * Subjects with current Axis I primary psychiatric diagnosis other than schizophrenia, at significant risk of suicide

Countries

United States

Outcome results

None listed

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