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

Solvay Pharmaceuticals

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Schizophrenia Schizoaffective Disorder Bipolar Disorder

Interventions

BifeprunoxDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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

Locations (1)

Site 1

Orange, California, United States

Data from ClinicalTrials.gov

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