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

Solvay

Status and phase: Completed; Phase 2

Conditions: Schizophrenia; Bipolar Disorder; Schizoaffective Disorder

Treatments: Drug: Bifeprunox

Study type: Interventional

Funder types: Industry

Identifiers

NCT00139919

S154.2.017

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind