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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 remission

Clinical 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

Page last updated: August 23, 2015

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