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OpenTrials
Completed

NCT Number: NCT00194038

Aripiprazole in Late Life Bipolar Disorder

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).

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Key information

Conditions

Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aripiprazole

Drug

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.

Other names: Abilify

Primary outcomes

  1. Blood pressure and pulse

    Time frame: 12 weeks

  2. Weight

    Time frame: 12 weeks

  3. Abnormal Involuntary Movement Scale (AIMS)

    Time frame: 12 weeks

  4. Barnes Akathisia Scale (BAS)

    Time frame: 12 weeks

  5. Simpson Angus Neurological Rating Scale (SAS)

    Time frame: 12 weeks

  6. Basic serum chemistry - screening and 12/study end

    Time frame: 12 weeks

  7. Complete blood count (CBC) with differential - screening and 12/study end

    Time frame: 12 weeks

  8. Electrocardiogram - screening and 12/study end

    Time frame: 12 weeks

  9. Young Mania Rating Scale (YMRS) - screening, baseline, and weeks 1, 2, 4, 8, and 12/study end

    Time frame: 12 weeks

  10. Hamilton Depression Rating Scale (HAM-D) - screening, baseline, and weeks 1, 2, 4, 8, and 12/study end

    Time frame: 12 weeks

  11. Clinical Global Impression (CGI)

    Time frame: 12 weeks

  12. Global Assessment Scale (GAS)

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

University Hospitals Cleveland Medical Center

Other

Collaborators

  • Bristol-Myers Squibb

Registry information

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Sep 19, 2005
Registry last updated
Dec 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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