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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00150553
First Posted: September 8, 2005
Last Update Posted: November 2, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Validus Pharmaceuticals
  Purpose
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 Intervention Phase
Bipolar Disorder Drug: Extended-release carbamazepine Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Validus Pharmaceuticals:

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

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

Estimated Enrollment: 102
Study Start Date: January 2005
Estimated Study Completion Date: October 2005
  Eligibility

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
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

ClinicalTrials.gov Identifier: NCT00150553     History of Changes
Other Study ID Numbers: SPD417-306
First Submitted: September 6, 2005
First Posted: September 8, 2005
Last Update Posted: November 2, 2007
Last Verified: May 2006

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