Status:
COMPLETED
Fixed-dose Safety and Efficacy Study of Asenapine for the Treatment of Acute Manic or Mixed Episode in Bipolar 1 Disorder (P05691)
Lead Sponsor:
Organon and Co
Conditions:
Bipolar 1 Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This trial will study the efficacy and safety of a fixed dose of asenapine in participants diagnosed with Bipolar 1 Disorder. Participants who qualify for the study will be randomly assigned to receiv...
Eligibility Criteria
Inclusion
- Each participant must be at least 18 years of age
- Male, or a female who is not of child-bearing potential or who is non-pregnant, non-lactating, and is using a medically accepted method of contraception
- Each participant must have a current diagnosis of Bipolar I Disorder, current episode manic or mixed
- Each participant must be confirmed to be experiencing an acute manic or mixed bipolar 1 episode
- Each participant must have discontinued the use of all prohibited psychotropic medications
Exclusion
- A participant must not have a primary Axis I disorder other than Bipolar 1 Disorder (i.e., an Axis 1 disorder other than Bipolar 1 Disorder that is primarily responsible for current symptoms and functional impairment)
- A participant must not currently (within the past 6 months) meet the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR™) criteria for substance abuse or dependence (excluding nicotine)
- A participant must not be at imminent risk of self-harm or harm to others, in the investigator's opinion based on clinical interview and responses provided on the Columbia Suicide Severity Rating Scale (CSSRS).
Key Trial Info
Start Date :
April 6 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 28 2014
Estimated Enrollment :
367 Patients enrolled
Trial Details
Trial ID
NCT00764478
Start Date
April 6 2012
End Date
May 28 2014
Last Update
June 18 2024
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