Treatment of Geriatric Bipolar Mood Disorders: A Pilot Study

This study has been completed.
Sponsor:
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00177567
First received: September 13, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Geriatric Bipolar Mood Disorders: A Pilot Study

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

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.

Estimated Enrollment: 60
Study Start Date: July 2001
Estimated Study Completion Date: January 2004
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.
  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00177567

Locations
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
University of Pittsubrgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Charles F Reynolds III, MD University of Pittsburgh
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00177567     History of Changes
Other Study ID Numbers: 010614
Study First Received: September 13, 2005
Last Updated: September 13, 2005
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Bipolar Disorder
Manic Depression
Elderly
Late-Life

Additional relevant MeSH terms:
Bipolar Disorder
Mood Disorders
Disease
Affective Disorders, Psychotic
Mental Disorders
Pathologic Processes
Lithium Carbonate
Tranylcypromine
Lithium
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Antipsychotic Agents
Monoamine Oxidase Inhibitors
Anti-Anxiety Agents

ClinicalTrials.gov processed this record on September 22, 2014