Status:
COMPLETED
Efficacy and Safety of SPD417 in Treatment of Manic Symptoms in Adults With Bipolar I Disorder
Lead Sponsor:
Validus Pharmaceuticals
Conditions:
Bipolar Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- DSM-IV criteria for bipolar I disorder
- Screen YMRS score =\> 16
- Women of childbearing potential agree to take adequate precautions against contraception
Exclusion
- Hospitalization required for treatment of psychiatric symptoms
- Patients who meet DSM-IV for ultra-rapid cycling
- History of serious suicide attempt requiring medical intervention
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
End Date :
October 1 2005
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT00150553
Start Date
January 1 2005
End Date
October 1 2005
Last Update
November 2 2007
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