Status:
COMPLETED
Safety of SPD417 Combined With Other Psychotropic Medications in the Treatment of Bipolar I Disorder
Lead Sponsor:
Validus Pharmaceuticals
Conditions:
Bipolar Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
End Date :
October 1 2005
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00150605
Start Date
February 1 2005
End Date
October 1 2005
Last Update
November 2 2007
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