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Trial record 78 of 408 for:    ARIPIPRAZOLE

Aripiprazole in Late Life Bipolar Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00194038
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : December 17, 2014
Bristol-Myers Squibb
Information provided by:
University Hospitals Cleveland Medical Center

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).

Condition or disease Intervention/treatment Phase
Bipolar Disorder Drug: Aripiprazole Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Aripiprazole in Late Life Bipolar Disorder
Study Start Date : April 2004
Actual Primary Completion Date : June 2006
Actual Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

Arm Intervention/treatment
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

Primary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00194038

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

Publications of Results:
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Responsible Party: Martha Sajatovic, Case Western Reserve University Identifier: NCT00194038     History of Changes
Other Study ID Numbers: 10864-01-L0363
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: December 17, 2014
Last Verified: January 2010
Keywords provided by University Hospitals Cleveland Medical Center:
Bipolar Disorder
Geriatric Psychiatry
Additional relevant MeSH terms:
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Bipolar Disorder
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Dopamine D2 Receptor Antagonists
Dopamine Antagonists