Aripiprazole in Late Life Bipolar Disorder

Bipolar Disorder Clinical Trial

Official title:

Aripiprazole in Late Life Bipolar Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00194038
• Other study ID #: 10864-01-L0363
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: December 16, 2014
• Start date: April 2004
• Est. completion date: June 2006

Study information

• Verified date: January 2010
• Source: University Hospital Case Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2006
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Case Medical Center	Bristol-Myers Squibb

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood pressure and pulse		12 weeks	Yes
Primary	Weight		12 weeks	No
Primary	Abnormal Involuntary Movement Scale (AIMS)		12 weeks	No
Primary	Barnes Akathisia Scale (BAS)		12 weeks	No
Primary	Simpson Angus Neurological Rating Scale (SAS)		12 weeks	No
Primary	Basic serum chemistry - screening and 12/study end		12 weeks	Yes
Primary	Complete blood count (CBC) with differential - screening and 12/study end		12 weeks	Yes
Primary	Electrocardiogram - screening and 12/study end		12 weeks	Yes
Primary	Young Mania Rating Scale (YMRS) - screening, baseline, and weeks 1, 2, 4, 8, and 12/study end		12 weeks	No
Primary	Hamilton Depression Rating Scale (HAM-D) - screening, baseline, and weeks 1, 2, 4, 8, and 12/study end		12 weeks	No
Primary	Clinical Global Impression (CGI)		12 weeks	No
Primary	Global Assessment Scale (GAS)		12 weeks	No