Treatment of Geriatric Bipolar Mood Disorders: A Pilot Study

Sponsor

University of Pittsburgh (Other)

Overall Status

Completed

CT.gov ID

NCT00177567

Collaborator

(none)

Enrollment

Locations

Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bipolar Disorder	Drug: lithium carbonate Drug: Depakote-ER Drug: risperidone Drug: olanzapine Drug: paroxetine Drug: bupropion Drug: lamotrigine Drug: venlafaxine Drug: tranylcypromine Drug: mirtazapine	Phase 4

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 Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Treatment of Geriatric Bipolar Mood Disorders: A Pilot Study

Study Start Date :

Jul 1, 2001

Study Completion Date :

Jan 1, 2004

Outcome Measures

Primary Outcome Measures

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

Measures of affective symptoms, functional status, side effects, and cognition tracked over acute, continuation, and maintenance phases of treatment. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	United States	15213
2	University of Pittsubrgh Medical Center	Pittsburgh	Pennsylvania	United States	15213