Progressively Decreasing Titration Schedules of Bifeprunox in Subjects With Schizophrenia or Bipolar Disorder

• Status: Completed
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is to assess the tolerability of bifeprunox with the progressive elimination of titration steps to achieve the shortest tolerated titration dosing to a dose of 40 mg/day in either schizophrenia or bipolar disorder subjects. Study duration is 2 months with an optional open-label 26-week extension study.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Solvay Pharmaceuticals
• Collaborators: H. Lundbeck A/S; Wyeth is now a wholly owned subsidiary of Pfizer

Criteria

Inclusion Criteria:

• Subjects with the current Diagnosis of Schizophrenia, Bipolar Type I Disorder according to DSM-IV TR criteria

• Age 18 to 55

• Body weight 100-250 lbs

• Be sufficiently stable to allow discontinuation of antipsychotic medication

Exclusion Criteria:

• Acutely psychotic subjects

• Subjects that are acutely manic

• Subjects with a psych diagnosis other than Bipolar Type I Disorder