Treatment of Geriatric Bipolar Mood Disorders: A Pilot Study - Full Text View

Sponsored by:	University of Pittsburgh
Information provided by:	University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00177567

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 IV

MedlinePlus related topics: Bipolar Disorder

Drug Information available for: Risperidone Paroxetine Paroxetine hydrochloride Paroxetine Mesylate Divalproex sodium Valproate Sodium Valproic acid Olanzapine Lamotrigine Bupropion hydrochloride Bupropion Mirtazapine Venlafaxine Venlafaxine hydrochloride Lithium carbonate Lithium citrate Tranylcypromine Tranylcypromine sulfate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title:	Treatment of Geriatric Bipolar Mood Disorders: A Pilot Study

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

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

An online resource for older individuals with mental health needs This link exits the ClinicalTrials.gov site

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

Keywords provided by University of Pittsburgh:

Bipolar Disorder
Manic Depression
Elderly
Late-Life

Study placed in the following topic categories:

Depression
Bipolar Disorder
Olanzapine
Risperidone
Lithium Carbonate
Mirtazapine
Tranylcypromine
Depressive Disorder
Paroxetine
Valproic Acid
Serotonin
Histamine

Calcium, Dietary
Affective Disorders, Psychotic
Dopamine
Mental Disorders
Venlafaxine
Bupropion
Mood Disorders
Lamotrigine
Histamine phosphate
Psychotic Disorders
Lithium

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Physiological Effects of Drugs
Psychotropic Drugs
Antiemetics
Calcium Channel Blockers
Membrane Transport Modulators
Serotonin Antagonists
Pathologic Processes
Therapeutic Uses
Monoamine Oxidase Inhibitors
Antidepressive Agents, Second-Generation
Antidepressive Agents

Tranquilizing Agents
Disease
Gastrointestinal Agents
Central Nervous System Depressants
Histamine Agents
Dopamine Antagonists
Enzyme Inhibitors
Cardiovascular Agents
Adrenergic alpha-Antagonists
Antimanic Agents
Antipsychotic Agents
Serotonin Uptake Inhibitors
Pharmacologic Actions
Antidepressive Agents, Tricyclic
Serotonin Agents

ClinicalTrials.gov processed this record on January 16, 2009