Status:
COMPLETED
12 Week Study of the Safety/Efficacy of Asenapine When Added to Lithium/Valproate in the Treatment of Bipolar Disorder (A7501008 / P05844 / MK-8274-017)
Lead Sponsor:
Organon and Co
Conditions:
Bipolar Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a 12-week study that will test the safety and efficacy of asenapine when used in addition to lithium or valproate for subjects with acute manic or mixed episodes of Bipolar I Disorder.
Eligibility Criteria
Inclusion
- Have bipolar I disorder, current episode manic or mixed
- Treated with lithium or valproic acid
Exclusion
- Have an unstable medical condition
- Clinically significant laboratory abnormality.
- Have a primary diagnosis other than bipolar I disorder.
Key Trial Info
Start Date :
June 2 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 22 2007
Estimated Enrollment :
326 Patients enrolled
Trial Details
Trial ID
NCT00145470
Start Date
June 2 2005
End Date
March 22 2007
Last Update
May 21 2024
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