Aripiprazole in Late Life Bipolar Disorder

Phase 4

Completed

• Conditions: Bipolar Disorder
• Interventions: Drug: Aripiprazole

• Registration Number: NCT00194038
• Lead Sponsor: 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).

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.

Study Timeline

• Study Start: 2004-04
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-19
• Primary Completion: 2006-06
• Study Completion: 2006-06
• Status Verified: 2010-01
• Last Update Submitted: 2014-12-16
• Last Update Posted: 2014-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Aripiprazole	-

Primary Outcome Measures

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