Efficacy and Safety of SPD417 in Treatment of Manic Symptoms in Adults With Bipolar I Disorder
Information source: Validus Pharmaceuticals
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bipolar Disorder
Intervention: Extended-release carbamazepine (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Validus Pharmaceuticals
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.
Clinical Details
Official title: A Phase IIIb, Randomized, Double-Blind, Parallel Group Study in Bipolar I Patients to Assess the Efficacy and Safety of SPD417 Administered Once Daily vs Twice Daily in the Treatment of Manic Symptoms
Study design: Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Efficacy Study
Primary outcome: Score on Young Mania Rating Scale (YMRS) at 12 weeks
Secondary outcome: Time to remissionClinical Global Impressions Scale - Bipolar Version HAM-D and MADRS scales for depression
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: January 2005
Ending date: October 2005
Last updated: November 1, 2007
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