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Aripiprazole in Late Life Bipolar Disorder

Primary Purpose

Bipolar Disorder

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Aripiprazole
Sponsored by
University Hospitals Cleveland Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder focused on measuring Bipolar Disorder, Geriatric Psychiatry, Aripiprazole

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Must have Bipolar disorder as confirmed by the Mini Neuropsychiatric Interview (MINI) Must be age 50 or older Must have sub-optimal response to current psychotropic management including at least one of the following: Behaviors and symptoms of irritability, agitation, mood liability or diminished ability to interact with others in their place of residence Diminished ability to take care of basic personal needs in their place of residence due to symptoms of bipolar disorder Intolerance to current psychotropic medications; and Must live in the Northeast Ohio area. Exclusion Criteria: An unstable medical illness, or a medical illness, which in the opinion of the study investigators, is likely to affect the outcome of the study DSM-IV substance dependence (except nicotine or caffeine) within the past 3 months; or Receiving carbamazepine.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    1

    Arm Description

    Outcomes

    Primary Outcome Measures

    Blood pressure and pulse
    Weight
    Abnormal Involuntary Movement Scale (AIMS)
    Barnes Akathisia Scale (BAS)
    Simpson Angus Neurological Rating Scale (SAS)
    Basic serum chemistry - screening and 12/study end
    Complete blood count (CBC) with differential - screening and 12/study end
    Electrocardiogram - screening and 12/study end
    Young Mania Rating Scale (YMRS) - screening, baseline, and weeks 1, 2, 4, 8, and 12/study end
    Hamilton Depression Rating Scale (HAM-D) - screening, baseline, and weeks 1, 2, 4, 8, and 12/study end
    Clinical Global Impression (CGI)
    Global Assessment Scale (GAS)

    Secondary Outcome Measures

    Full Information

    First Posted
    September 13, 2005
    Last Updated
    December 16, 2014
    Sponsor
    University Hospitals Cleveland Medical Center
    Collaborators
    Bristol-Myers Squibb
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00194038
    Brief Title
    Aripiprazole in Late Life Bipolar Disorder
    Official Title
    Aripiprazole in Late Life Bipolar Disorder
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2004 (undefined)
    Primary Completion Date
    June 2006 (Actual)
    Study Completion Date
    June 2006 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University Hospitals Cleveland Medical Center
    Collaborators
    Bristol-Myers Squibb

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this research study is to analyze the effectiveness and tolerability of a new medication, aripiprazole (Abilify), in individuals age 50 years and older who have bipolar disorder (manic-depressive illness).
    Detailed Description
    While medications such as valproate (Depakote and others) and lithium are generally considered first-line agents in late life bipolar disorder, side effects are common, and many individuals with bipolar disorder continue to have symptoms in spite of medication treatment. A continuing unmet need is the availability of medications that are generally well- tolerated and effective in later life bipolar disorders. Antipsychotic medications such as Abilify are known to be effective for related conditions such as schizophrenia and are also used by some physicians in clinical settings in combination with mood stabilizing medications (Lithium, Depakote and others) to treat symptoms of bipolar disorder. Currently Abilify is approved by the FDA to treat schizophrenia and to treat bipolar disorder.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bipolar Disorder
    Keywords
    Bipolar Disorder, Geriatric Psychiatry, Aripiprazole

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Aripiprazole
    Other Intervention Name(s)
    Abilify
    Intervention Description
    Patients were continued on treatment with their existing mood stabilizing medication, and upon enrollment were initiated on aripiprazole augmentation treatment. The initial starting dose of aripiprazole was 5 mg/day, with gradual upward titration as tolerated. Initiation of new additional antipsychotic medications was not permitted during the course of the study, and antipsychotic medications prescribed at study start were tapered and discontinued by week 4 of the study if possible.
    Primary Outcome Measure Information:
    Title
    Blood pressure and pulse
    Time Frame
    12 weeks
    Title
    Weight
    Time Frame
    12 weeks
    Title
    Abnormal Involuntary Movement Scale (AIMS)
    Time Frame
    12 weeks
    Title
    Barnes Akathisia Scale (BAS)
    Time Frame
    12 weeks
    Title
    Simpson Angus Neurological Rating Scale (SAS)
    Time Frame
    12 weeks
    Title
    Basic serum chemistry - screening and 12/study end
    Time Frame
    12 weeks
    Title
    Complete blood count (CBC) with differential - screening and 12/study end
    Time Frame
    12 weeks
    Title
    Electrocardiogram - screening and 12/study end
    Time Frame
    12 weeks
    Title
    Young Mania Rating Scale (YMRS) - screening, baseline, and weeks 1, 2, 4, 8, and 12/study end
    Time Frame
    12 weeks
    Title
    Hamilton Depression Rating Scale (HAM-D) - screening, baseline, and weeks 1, 2, 4, 8, and 12/study end
    Time Frame
    12 weeks
    Title
    Clinical Global Impression (CGI)
    Time Frame
    12 weeks
    Title
    Global Assessment Scale (GAS)
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Must have Bipolar disorder as confirmed by the Mini Neuropsychiatric Interview (MINI) Must be age 50 or older Must have sub-optimal response to current psychotropic management including at least one of the following: Behaviors and symptoms of irritability, agitation, mood liability or diminished ability to interact with others in their place of residence Diminished ability to take care of basic personal needs in their place of residence due to symptoms of bipolar disorder Intolerance to current psychotropic medications; and Must live in the Northeast Ohio area. Exclusion Criteria: An unstable medical illness, or a medical illness, which in the opinion of the study investigators, is likely to affect the outcome of the study DSM-IV substance dependence (except nicotine or caffeine) within the past 3 months; or Receiving carbamazepine.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Martha Sajatovic, MD
    Organizational Affiliation
    Case Western Reserve University School of Medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    18312036
    Citation
    Sajatovic M, Coconcea N, Ignacio RV, Blow FC, Hays RW, Cassidy KA, Meyer WJ. Aripiprazole therapy in 20 older adults with bipolar disorder: a 12-week, open-label trial. J Clin Psychiatry. 2008 Jan;69(1):41-6. doi: 10.4088/jcp.v69n0106.
    Results Reference
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    Aripiprazole in Late Life Bipolar Disorder

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