Clinical trial NCT00194038: Aripiprazole in Late Life Bipolar Disorder
Official title: Aripiprazole in Late Life Bipolar Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bipolar Disorder
Keywords: Bipolar Disorder
Geriatric Psychiatry
Aripiprazole
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
First posted: 2005-09-19
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Blood pressure and pulse
timeFrame: 12 weeks
measure: Weight
timeFrame: 12 weeks
measure: Abnormal Involuntary Movement Scale (AIMS)
timeFrame: 12 weeks
measure: Barnes Akathisia Scale (BAS)
timeFrame: 12 weeks
measure: Simpson Angus Neurological Rating Scale (SAS)
timeFrame: 12 weeks
measure: Basic serum chemistry - screening and 12/study end
timeFrame: 12 weeks
measure: Complete blood count (CBC) with differential - screening and 12/study end
timeFrame: 12 weeks
measure: Electrocardiogram - screening and 12/study end
timeFrame: 12 weeks
measure: Young Mania Rating Scale (YMRS) - screening, baseline, and weeks 1, 2, 4, 8, and 12/study end
timeFrame: 12 weeks
measure: Hamilton Depression Rating Scale (HAM-D) - screening, baseline, and weeks 1, 2, 4, 8, and 12/study end
timeFrame: 12 weeks
measure: Clinical Global Impression (CGI)
timeFrame: 12 weeks
measure: Global Assessment Scale (GAS)
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Case Western Reserve University School of Medicine
name: Martha Sajatovic, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.