Status:
COMPLETED
3-week Study of Asenapine, Olanzapine and Placebo for Treatment of Bipolar Mania (P07009)
Lead Sponsor:
Organon and Co
Collaborating Sponsors:
Pfizer
Conditions:
Bipolar Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Bipolar disorder is characterized by mood swings that range from high (manic) to low (depressed) states. Sometimes, symptoms of both depression and mania are present (mixed episodes). Asenapine is an ...
Eligibility Criteria
Inclusion
- Have a Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) diagnosis of bipolar I disorder, current episode manic or mixed.
Exclusion
- Participants with unstable medical conditions or clinically significant laboratory abnormalities or participants who are rapid cyclers (i.e., have had 4 or more (including current) mood episodes in the past 12 months); have any other psychiatric disorder other than bipolar I disorder as a primary diagnosis.
Key Trial Info
Start Date :
December 14 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 28 2006
Estimated Enrollment :
489 Patients enrolled
Trial Details
Trial ID
NCT00159796
Start Date
December 14 2004
End Date
April 28 2006
Last Update
August 15 2024
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