Treatment of Geriatric Bipolar Mood Disorders: A Pilot Study

NCT00177567 | Completed Phase 4

• 1 other identifier: 010614
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Bipolar Disorder

Keywords

Bipolar Disorder; Manic Depression; Elderly; Late-Life

Outcome Measures

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.

Interventions

lithium carbonate DRUG

Depakote-ER DRUG

risperidone DRUG

olanzapine DRUG

paroxetine DRUG

bupropion DRUG

lamotrigine DRUG

venlafaxine DRUG

tranylcypromine DRUG

mirtazapine DRUG

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• DSM-IV diagnosis of Bipolar Disorder
• Folstein Mini-Mental Status Exam score of 18 or higher

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (2)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Pittsubrgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Lithium Carbonate; Valproic Acid; Risperidone; Olanzapine; Paroxetine; Bupropion; Lamotrigine; Venlafaxine Hydrochloride; Tranylcypromine; Mirtazapine

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Carbonates; Alkalies; Inorganic Chemicals; Carbonic Acid; Carbon Compounds, Inorganic; Lithium Compounds; Pentanoic Acids; Valerates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Piperidines; Propiophenones; Ketones; Triazines; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Phenethylamines; Ethylamines; Amines; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Propylamines; Dibenzazepines; Heterocyclic Compounds, 3-Ring

Study Officials

• Charles F Reynolds III, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 15, 2005
• Study Start: July 1, 2001
• Study Completion: January 1, 2004
• Last Updated: September 15, 2005

Record last verified: 2005-09

Locations

US (2)