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

Phase 3

Completed

• Conditions: Bipolar Disorder

• Registration Number: NCT00150553
• Lead Sponsor: Validus Pharmaceuticals

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01
• Study First Submitted: 2005-09-06
• Study First Submitted QC: 2005-09-06
• Study First Posted: 2005-09-08
• Study Completion: 2005-10
• Status Verified: 2006-05
• Last Update Submitted: 2007-11-01
• Last Update Posted: 2007-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Score on Young Mania Rating Scale (YMRS) at 12 weeks

Secondary Outcome Measures

Name	Time	Method
Time to remission
Clinical Global Impressions Scale - Bipolar Version
HAM-D and MADRS scales for depression