NCT00194038

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2004

Typical duration for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

December 17, 2014

Status Verified

January 1, 2010

Enrollment Period

2.2 years

First QC Date

September 13, 2005

Last Update Submit

December 16, 2014

Conditions

Bipolar Disorder

Keywords

Bipolar DisorderGeriatric PsychiatryAripiprazole

Outcome Measures

Primary Outcomes (12)

  • Blood pressure and pulse

    12 weeks

  • Weight

    12 weeks

  • Abnormal Involuntary Movement Scale (AIMS)

    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

  • Complete blood count (CBC) with differential - screening and 12/study end

    12 weeks

  • Electrocardiogram - screening and 12/study end

    12 weeks

  • Young Mania Rating Scale (YMRS) - screening, baseline, and weeks 1, 2, 4, 8, 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

Study Arms (1)

1

EXPERIMENTAL
Drug: Aripiprazole

Interventions

AripiprazoleDRUG

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.

Also known as: Abilify
1

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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. doi: 10.4088/jcp.v69n0106.

    PMID: 18312036RESULT

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Martha Sajatovic, MD

    Case Western Reserve University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 19, 2005

Study Start

April 1, 2004

Primary Completion

June 1, 2006

Study Completion

June 1, 2006

Last Updated

December 17, 2014

Record last verified: 2010-01