Status:
COMPLETED
40 Week Trial to Study the Safety of Asenapine When Added to Lithium or Valproate in the Treatment of Bipolar Disorder (A7501009)(P05786)
Lead Sponsor:
Organon and Co
Conditions:
Bipolar Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The primary objective of this trial was to characterize the long-term (up to 40 weeks) safety and tolerability of asenapine in bipolar I disorder subjects who had not completely responded to continuin...
Eligibility Criteria
Inclusion
- Have bipolar I disorder (current episode manic or mixed), be treated with lithium or valproic acid, and have completed the a 12-week lead-in trial
Exclusion
- Have an unstable medical condition or clinically significant laboratory abnormality.
- Have a primary diagnosis other than bipolar I disorder.
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT00145509
Start Date
August 1 2005
End Date
December 1 2007
Last Update
February 8 2022
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.