Treatment of Geriatric Bipolar Mood Disorders: A Pilot Study

NCT ID: NCT00177567

Last Updated: 2005-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-07-31

Study Completion Date

2004-01-31

Brief Summary

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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

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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.

Conditions

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Bipolar Disorder

Keywords

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Bipolar Disorder Manic Depression Elderly Late-Life

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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lithium carbonate

Intervention Type DRUG

Depakote-ER

Intervention Type DRUG

risperidone

Intervention Type DRUG

olanzapine

Intervention Type DRUG

paroxetine

Intervention Type DRUG

bupropion

Intervention Type DRUG

lamotrigine

Intervention Type DRUG

venlafaxine

Intervention Type DRUG

tranylcypromine

Intervention Type DRUG

mirtazapine

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pittsburgh

OTHER

Sponsor Role lead

Principal Investigators

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Charles F Reynolds III, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Site Status

University of Pittsubrgh Medical Center

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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010614

Identifier Type: -

Identifier Source: org_study_id