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Completed

NCT Number: NCT00177567

Treatment of Geriatric Bipolar Mood Disorders: A Pilot Study

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.

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Key information

Conditions

Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lithium Carbonate

Drug

Depakote-ER

Drug

Risperidone

Drug

Olanzapine

Drug

paroxetine

Drug

bupropion

Drug

Lamotrigine

Drug

Venlafaxine

Drug

Tranylcypromine

Drug

mirtazapine

Drug

Primary outcomes

  1. 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 outcomes

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

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Important dates

Study start
2001
Study completion
2004
First posted
Sep 15, 2005
Registry last updated
Sep 15, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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