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

History of Changes

Tracking Information
First Received Date ^ICMJE	September 6, 2005
Last Updated Date	November 1, 2007
Start Date ^ICMJE	January 2005
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: September 6, 2005)	Score on Young Mania Rating Scale (YMRS) at 12 weeks
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00150553 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: September 6, 2005)	Time to remission Clinical Global Impressions Scale - Bipolar Version HAM-D and MADRS scales for depression
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Efficacy and Safety of SPD417 in Treatment of Manic Symptoms in Adults With Bipolar I Disorder
Official Title ^ICMJE	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
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Condition ^ICMJE	Bipolar Disorder
Intervention ^ICMJE	Drug: Extended-release carbamazepine
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	102
Completion Date	October 2005
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00150553
Other Study ID Numbers ^ICMJE	SPD417-306
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Validus Pharmaceuticals
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Validus Pharmaceuticals
Verification Date	May 2006
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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