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Asenapine in the Treatment of Older Adults With Bipolar Disorder

NCT ID: NCT01460290

Last Updated: 2014-12-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2014-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Bipolar Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Asenapine

12-weeks of open-label asenapine treatment

Group Type EXPERIMENTAL

Asenapine

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Saphris

Eligibility Criteria

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Inclusion Criteria

* Subjects must have type I Bipolar disorder by DSM-IV criteria confirmed on the Mini Neuropsychiatric Interview (MINI)
* Subjects must be age 60 or older
* Subjects must have sub-optimal response to current psychotropic management including at least one of the following:

1. Behaviors and symptoms of irritability, agitation, mood lability or diminished ability to interact with others in their place of residence
2. Diminished ability to take care of basic personal needs in their place of residence due to symptoms of BD

Exclusion Criteria

* History of intolerance or resistance to asenapine
* Clinical diagnosis of dementia or Mini-mental state (MMSE) \< 24
* History of TIA, stroke or MI within the past 12 months
* Medical illness that is the clear, underlying etiology of BD
* Unstable medical illness or condition including prolonged QT interval, which in the opinion of the study investigators, is likely to affect the outcome of the study or the subject's safety
* DSM-IV substance dependence (except nicotine or caffeine) within the past 3 months.
* Rapid cycling BD defined as 4 or more discrete mood episodes within the previous 12 months.
* At high risk for self-harm or suicide
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Case Western Reserve University

OTHER

Sponsor Role collaborator

University Hospitals Cleveland Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Martha Sajatovic

Professor of Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Martha Sajatovic, M.D.

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center

Locations

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University Hospitals Case Medical Center

Cleveland, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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39358

Identifier Type: -

Identifier Source: org_study_id