Asenapine in the Treatment of Older Adults With Bipolar Disorder

Status Completed

Clinical Trial Summary

Objectives: The investigators propose a first-ever, prospective trial of asenapine in older adults with bipolar disorder (BD) to evaluate effects on mood symptoms, tolerability and functional/general health status. Given the dearth of treatment data on older adults with BD, findings are likely to be of substantial clinical interest, may inform larger future studies and will assist in refining bipolar treatment recommendations.

Hypotheses:

Primary: Asenapine therapy will be associated with reduced bipolar manic and depressive symptoms in older adults with BD.

Secondary: Asenapine therapy will be associated with improved functional and general health status, improved global psychopathology, and good tolerability in older adults with BD.

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Bipolar Disorder

Clinical Trial Details

NCT number	NCT01460290
Study type	Interventional
Source	University Hospital Case Medical Center
Contact
Status	Completed
Phase	Phase 4
Start date	October 2011
Completion date	March 2014

View Details

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