Treatment of Geriatric Bipolar Mood Disorders: A Pilot Study

Bipolar Disorder Clinical Trial

Official title:

Treatment of Geriatric Bipolar Mood Disorders: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00177567
• Other study ID #: 010614
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: September 13, 2005
• Start date: July 2001
• Est. completion date: January 2004

Study information

• Verified date: September 2005
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder
• Mood Disorders

Intervention

Drug:
• lithium carbonate

• Depakote-ER

• risperidone

• olanzapine

• paroxetine

• bupropion

• lamotrigine

• venlafaxine

• tranylcypromine

• mirtazapine

Locations

Country	Name	City	State
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	University of Pittsubrgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Measures of affective symptoms, functional status, side effects, and cognition tracked over acute, continuation, and maintenance phases of treatment.