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Aripiprazole in Late Life Bipolar Disorder

This study has been completed.
Bristol-Myers Squibb
Information provided by:
University Hospitals Cleveland Medical Center Identifier:
First received: September 13, 2005
Last updated: December 16, 2014
Last verified: January 2010
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).

Condition Intervention Phase
Bipolar Disorder Drug: Aripiprazole Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Aripiprazole in Late Life Bipolar Disorder

Resource links provided by NLM:

Further study details as provided by University Hospitals Cleveland Medical Center:

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

Enrollment: 20
Study Start Date: April 2004
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Aripiprazole
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 Name: Abilify

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.


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00194038

Sponsors and Collaborators
University Hospitals Cleveland Medical Center
Bristol-Myers Squibb
Principal Investigator: Martha Sajatovic, MD Case Western Reserve University School of Medicine
  More Information

Responsible Party: Martha Sajatovic, Case Western Reserve University Identifier: NCT00194038     History of Changes
Other Study ID Numbers: 10864-01-L0363
Study First Received: September 13, 2005
Last Updated: December 16, 2014

Keywords provided by University Hospitals Cleveland Medical Center:
Bipolar Disorder
Geriatric Psychiatry

Additional relevant MeSH terms:
Bipolar Disorder
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs processed this record on July 21, 2017