Back to resultsSafety of SPD417 Combined With Other Psychotropic Medications in the Treatment of Bipolar I Disorder
Primary Purpose
Bipolar Disorder
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Extended-release carbamazepine
Sponsored by
About this trial
This is an interventional treatment trial for Bipolar Disorder
Eligibility Criteria
Inclusion Criteria: DSM-IV criteria for Bipolar I disorder Screening YMRS score =>16 Women of childbearing potential agree to take adequate precautions against contraception Currently receiving treatment with antipsychotic therapy or combination therapy of mood stabilizer and antipsychotic 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 Female subjects who are pregnant or lactating, including females with a positive pregnancy test at screening
Sites / Locations
Outcomes
Primary Outcome Measures
Safety as assessed by treatment-emergent adverse events over 8 weeks of treatment
Secondary Outcome Measures
YMRS Scale
Clinical Global Impressions Scale - Bipolar Version
HAM-D and MADRS Scales for Depression
Full Information
NCT ID
NCT00150605
First Posted
September 6, 2005
Last Updated
November 1, 2007
Sponsor
Validus Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00150605
Brief Title
Safety of SPD417 Combined With Other Psychotropic Medications in the Treatment of Bipolar I Disorder
Official Title
A Phase IIIb, Open Label Observational Study of SPD417 Used in Combination With Other Psychotropic Medications for the Treatment of Bipolar I Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
June 2006
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Validus Pharmaceuticals
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety of SPD417 when given with other psychotropic medications to treat bipolar I disorder.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Extended-release carbamazepine
Primary Outcome Measure Information:
Title
Safety as assessed by treatment-emergent adverse events over 8 weeks of treatment
Secondary Outcome Measure Information:
Title
YMRS Scale
Title
Clinical Global Impressions Scale - Bipolar Version
Title
HAM-D and MADRS Scales for Depression
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
DSM-IV criteria for Bipolar I disorder
Screening YMRS score =>16
Women of childbearing potential agree to take adequate precautions against contraception
Currently receiving treatment with antipsychotic therapy or combination therapy of mood stabilizer and antipsychotic
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
Female subjects who are pregnant or lactating, including females with a positive pregnancy test at screening
12. IPD Sharing Statement
Learn more about this trial
Safety of SPD417 Combined With Other Psychotropic Medications in the Treatment of Bipolar I Disorder
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