Twice Daily Titration Study of Bifeprunox in Subjects With Schizophrenia

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Schizophrenia Mental Disorders Psychotic Disorders Schizoaffective Disorder Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Site 1

National City, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bifeprunox

Drug

Sponsors and collaborators

Lead sponsor

Solvay Pharmaceuticals

Industry

Collaborators

H. Lundbeck A/S
Wyeth is now a wholly owned subsidiary of Pfizer

Registry information

Official study title

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

Important dates

Study start: 2005
Primary completion: 2006
Study completion: 2006
First posted: Aug 31, 2005
Registry last updated: Jan 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed