Efficacy and Safety of SPD417 in Treatment of Manic Symptoms in Adults With Bipolar I Disorder

• Status: Completed
• Trial end date: 2005-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the efficacy and safety of SPD417 in treating bipolar manic symptoms, when given once daily in the evening vs. twice daily.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Validus Pharmaceuticals
• Treatments: Carbamazepine

Criteria

Inclusion Criteria:

• DSM-IV criteria for bipolar I disorder

• Screen YMRS score => 16

• Women of childbearing potential agree to take adequate precautions against contraception

Exclusion Criteria:

• Hospitalization required for treatment of psychiatric symptoms

• Patients who meet DSM-IV for ultra-rapid cycling

• History of serious suicide attempt requiring medical intervention