drugset / Trial / NCT01460290

Asenapine in the Treatment of Older Adults With Bipolar Disorder

NCT01460290

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2011-10
Primary completion
2014-03
Completion
2014-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Asenapine Other / unclassified 20 mg Oral

Indications