Treatment of Geriatric Bipolar Mood Disorders: A Pilot Study

Phase 4

Completed

• Conditions: Bipolar Disorder

• Registration Number: NCT00177567
• Lead Sponsor: University of Pittsburgh

Brief Summary

The purpose of this study is to collect pilot data on the feasibility of recruiting, eliciting informed consent, assessing, treating, and following patients aged 60 and older with bipolar mood disorders.

Detailed Description

Study specific aims are:

* to establish a recruitment, referral, and collaborative network for elderly bipolar patients, in collaboration with the NIMH funded STEP-BD

* to establish an outpatient treatment clinic at the Bellefield Towers site of the NIMH funded Intervention Research Center for Late Life Mood Disorders

* to implement standardized care pathways compatible with STEP-BD treatment algorithms for mood stabilizing pharmacotherapy.

* to document short- and long-term treatment response with respect to affective symptoms, sleep, general life functioning, cognition, treatment-emergent side effects

* to establish the clinical infrastructure necessary for randomized controlled clinical trials and for clinical research training in bipolar mood disorders of late-life.

Study Timeline

• Study Start: 2001-07
• Study Completion: 2004-01
• Status Verified: 2005-09
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Last Update Submitted: 2005-09-13
• Study First Posted: 2005-09-15
• Last Update Posted: 2005-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• DSM-IV diagnosis of Bipolar Disorder
• Folstein Mini-Mental Status Exam score of 18 or higher

Exclusion Criteria

• Medical condition that precludes the use of both lithium and depakote
• If mood disturbance is deemed an organic mood disorder (i.e., iatrogenic, secondary to medication)
• If refuse to designate someone who the study staff can contact about bipolar symptoms, concerns about the subject's health, in an emergency, and/or inability to reach the subject.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The percent of subjects remitting from their index affective episode, the time to remission, the percent of partially and non-remitting patients, the incidence of relapse during continuation treatment, and of recurrence during maintenance treatment

Secondary Outcome Measures

Name	Time	Method
Measures of affective symptoms, functional status, side effects, and cognition tracked over acute, continuation, and maintenance phases of treatment.

Trial Locations

Locations (2)

University of Pittsubrgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States