Efficacy and Safety of SPD417 in Treatment of Manic Symptoms in Adults With Bipolar I Disorder
Information source: Validus Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015 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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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
Last updated: November 1, 2007
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