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Aripiprazole in Late Life Bipolar Disorder
This study has been completed.
Study NCT00194038   Information provided by University Hospitals of Cleveland
First Received: September 13, 2005   Last Updated: January 23, 2009   History of Changes

September 13, 2005
January 23, 2009
April 2004
June 2006   (final data collection date for primary outcome measure)
  • Blood pressure and pulse - screening, baseline, and weeks 1, 2, 4, 8, and 12/study end [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Weight - screening, baseline, and weeks 1, 2, 4, 8, and 12/study end [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Abnormal Involuntary Movement Scale (AIMS) - screening, baseline, and weeks 1, 2, 4, 8, and 12/study end [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Barnes Akathisia Scale (BAS) - screening, baseline, and weeks 1, 2, 4, 8, and 12/study end [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Simpson Angus Neurological Rating Scale (SAS) - screening, baseline, and weeks 1, 2, 4, 8, and 12/study end [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Basic serum chemistry - screening and 12/study end [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Complete blood count (CBC) with differential - screening and 12/study end [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Electrocardiogram - screening and 12/study end [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Young Mania Rating Scale (YMRS) - screening, baseline, and weeks 1, 2, 4, 8, and 12/study end [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Hamilton Depression Rating Scale (HAM-D) - screening, baseline, and weeks 1, 2, 4, 8, and 12/study end [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Clinical Global Impression (CGI) - screening, baseline, and weeks 1, 2, 4, 8, and 12/study end [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Global Assessment Scale (GAS) - screening, baseline, and weeks 1, 2, 4, 8, and 12/study end [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Blood pressure and pulse - screening, baseline, and weeks 1, 2, 4, 8, and 12/study end
  • Weight - screening, baseline, and weeks 1, 2, 4, 8, and 12/study end
  • Abnormal Involuntary Movement Scale (AIMS) - screening, baseline, and weeks 1, 2, 4, 8, and 12/study end
  • Barnes Akathisia Scale (BAS) - screening, baseline, and weeks 1, 2, 4, 8, and 12/study end
  • Simpson Angus Neurological Rating Scale (SAS) - screening, baseline, and weeks 1, 2, 4, 8, and 12/study end
  • 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) - screening, baseline, and weeks 1, 2, 4, 8, and 12/study end
  • Global Assessment Scale (GAS) - screening, baseline, and weeks 1, 2, 4, 8, and 12/study end
  • Tolerability:
  • Efficacy:
Complete list of historical versions of study NCT00194038 on ClinicalTrials.gov Archive Site
 
 
 
Aripiprazole in Late Life Bipolar Disorder
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).

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.

Phase IV
Interventional
Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Bipolar Disorder
Drug: Aripiprazole
 
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.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
20
June 2006
June 2006   (final data collection date for primary outcome measure)

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.
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00194038
Martha Sajatovic, Case Western Reserve University
10864-01-L0363
University Hospitals of Cleveland
Bristol-Myers Squibb
Principal Investigator: Martha Sajatovic, MD Case Western Reserve University School of Medicine
University Hospitals of Cleveland
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP