Overview

Twice Daily Titration Study of Bifeprunox in Subjects With Schizophrenia

Status:
Completed
Trial end date:
2006-10-01
Target enrollment:
0
Participant gender:
All
Summary
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.
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 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