We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

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

September 6, 2005
September 8, 2005
November 2, 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
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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.
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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Not Provided
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