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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:
Information provided by:
Validus Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00150553
First received: September 6, 2005
Last updated: November 1, 2007
Last verified: May 2006
  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-Blind
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

ClinicalTrials.gov Identifier: NCT00150553     History of Changes
Other Study ID Numbers: SPD417-306
Study First Received: September 6, 2005
Last Updated: November 1, 2007

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

ClinicalTrials.gov processed this record on June 27, 2017