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Asenapine in the Treatment of Older Adults With Bipolar Disorder

NCT01460290 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2014-12-30

Study results available
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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.

Conditions

Interventions

DRUG

Asenapine

Asenapine will be administered open-label in pill form. Asenapine will be initiated at 5 mg twice a day and increased as tolerated to a maximum of 20 mg/day. It is anticipated that maximum stable dosing will be achieved by 4 weeks of treatment, although dosage may be reduced due to tolerability concerns at the discretion of the treating research psychiatrist.

Sponsors & Collaborators

  • Case Western Reserve University

    collaborator OTHER

  • University Hospitals Cleveland Medical Center

    lead OTHER

Principal Investigators

  • Martha Sajatovic, M.D. · University Hospitals Cleveland Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01460290 on ClinicalTrials.gov