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OpenTrials
Completed

NCT Number: NCT00141479

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

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.

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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

Wichita, Kansas, United States

Who can participate

Healthy volunteers accepted: No

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

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

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 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

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Sep 1, 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.

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