Twice Daily Titration Study of Bifeprunox in Subjects With Schizophrenia

Solvay

Status and phase: Completed; Phase 2

Conditions: Schizophrenia; Schizoaffective Disorder

Treatments: Drug: Bifeprunox

Study type: Interventional

Funder types: Industry

Identifiers

NCT00139906

S154.2.016

Details and patient eligibility

About

This study is to assess the safety and tolerability of a five-day titration schedule (using twice daily dosing for the first three days) to achieve the highest proposed dose of 40 mg daily. The study duration is two months.

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects who have current diagnosis of Schizophrenia or Schizoaffective disorder
• Body weight of 100-250 lbs
• Male or females
• 18-55 years of age

Exclusion criteria

• Subjects who are acutely psychotic
• Subjects with current Axis I primary psychiatric diagnosis other than schizophrenia, at significant risk of suicide

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind