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

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ClinicalTrials.gov Identifier: NCT00150553
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : November 2, 2007
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Drug: Extended-release carbamazepine Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : January 2005
Estimated Study Completion Date : October 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Score on Young Mania Rating Scale (YMRS) at 12 weeks

Secondary Outcome Measures :
  1. Time to remission
  2. Clinical Global Impressions Scale - Bipolar Version
  3. HAM-D and MADRS scales for depression

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

ClinicalTrials.gov Identifier: NCT00150553     History of Changes
Other Study ID Numbers: SPD417-306
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: November 2, 2007
Last Verified: May 2006

Additional relevant MeSH terms:
Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action