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

September 6, 2005
November 1, 2007
January 2005
Not Provided
Score on Young Mania Rating Scale (YMRS) at 12 weeks
Same as current
Complete list of historical versions of study NCT00150553 on ClinicalTrials.gov Archive Site
  • Time to remission
  • Clinical Global Impressions Scale - Bipolar Version
  • HAM-D and MADRS scales for depression
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of SPD417 in Treatment of Manic Symptoms in Adults With Bipolar I Disorder
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Bipolar Disorder
Drug: Extended-release carbamazepine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
102
October 2005
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00150553
SPD417-306
Not Provided
Not Provided
Validus Pharmaceuticals
Not Provided
Not Provided
Validus Pharmaceuticals
May 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP