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Treatment of Geriatric Bipolar Mood Disorders: A Pilot Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00177567
First Posted: September 15, 2005
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Pittsburgh
  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
Intervention Model: Single Group Assignment
Masking: None (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

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00177567     History of Changes
Other Study ID Numbers: 010614
First Submitted: September 13, 2005
First Posted: September 15, 2005
Last Update Posted: December 9, 2005
Last Verified: September 2005

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

Additional relevant MeSH terms:
Disease
Bipolar Disorder
Mood Disorders
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders
Risperidone
Olanzapine
Valproic Acid
Lithium Carbonate
Tranylcypromine
Bupropion
Paroxetine
Lamotrigine
Venlafaxine Hydrochloride
Mirtazapine
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Dopamine Uptake Inhibitors