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Treatment of Geriatric Bipolar Mood Disorders: A Pilot Study

Primary Purpose

Bipolar Disorder

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
lithium carbonate
Depakote-ER
risperidone
olanzapine
paroxetine
bupropion
lamotrigine
venlafaxine
tranylcypromine
mirtazapine
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder focused on measuring Bipolar Disorder, Manic Depression, Elderly, Late-Life

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • University of Pittsburgh Medical Center
  • University of Pittsubrgh Medical Center

Outcomes

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.

Full Information

First Posted
September 13, 2005
Last Updated
September 13, 2005
Sponsor
University of Pittsburgh
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1. Study Identification

Unique Protocol Identification Number
NCT00177567
Brief Title
Treatment of Geriatric Bipolar Mood Disorders: A Pilot Study
Official Title
Treatment of Geriatric Bipolar Mood Disorders: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
July 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Pittsburgh

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder
Keywords
Bipolar Disorder, Manic Depression, Elderly, Late-Life

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
lithium carbonate
Intervention Type
Drug
Intervention Name(s)
Depakote-ER
Intervention Type
Drug
Intervention Name(s)
risperidone
Intervention Type
Drug
Intervention Name(s)
olanzapine
Intervention Type
Drug
Intervention Name(s)
paroxetine
Intervention Type
Drug
Intervention Name(s)
bupropion
Intervention Type
Drug
Intervention Name(s)
lamotrigine
Intervention Type
Drug
Intervention Name(s)
venlafaxine
Intervention Type
Drug
Intervention Name(s)
tranylcypromine
Intervention Type
Drug
Intervention Name(s)
mirtazapine
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Measures of affective symptoms, functional status, side effects, and cognition tracked over acute, continuation, and maintenance phases of treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles F Reynolds III, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
University of Pittsubrgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Treatment of Geriatric Bipolar Mood Disorders: A Pilot Study

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