Aripiprazole in Late Life Bipolar Disorder

University Hospitals (UH)

Status and phase: Completed; Phase 4

Conditions: Bipolar Disorder

Treatments: Drug: Aripiprazole

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00194038

10864-01-L0363

Details and patient eligibility

About

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).

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

1

Experimental group

Treatment:

Drug: Aripiprazole