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Completed

NCT Number: NCT00347425

Switch Study of Existing Atypical Antipsychotics to Bifeprunox

The study will evaluate the safety and tolerability of switching subjects with schizophrenia or schizoaffective disorder from their existing antipsychotic medication to Bifeprunox.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Site 302, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Males or females, 18-65 years, meeting DSM-IV TR diagnosis of Schizophrenia or Schizoaffective Disorder for whom a switch is indicated

Exclusion criteria

  • Acutely psychotic or with a current Axis I primary psychiatric diagnosis other than schizophrenia or schizoaffective disorder based on DSM-IV TR criteria

Treatment and study plan

Aripiprazole

Drug

Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox

Olanzapine

Drug

Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox

Risperidone

Drug

Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox

Quetiapine

Drug

Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox

Ziprasidone

Drug

Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox

Primary outcomes

  1. Successful switch defined as those who complete the 4 weeks core study with no worsening of 2 successive post baseline assessments on the CGIS, exacerbation of EPS, or cardiovascular risk factors (body weight and fasting triglycerides) from baseline.

    Time frame: 4 weeks

Secondary outcomes

  1. Adverse events

    Time frame: 4 weeks

  2. Adverse events

    Time frame: 26 weeks

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 Multicenter, Open-Label, Parallel-Group, Randomized, Flexible Dose Study To Evaluate the Safety and Tolerability of Switching From Existing Atypical Antipsychotics to Bifeprunox in Subjects With Schizophrenia or Schizoaffective Disorder

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jul 4, 2006
Registry last updated
May 21, 2008

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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