Treatment of Geriatric Bipolar Mood Disorders: A Pilot Study
Information source: University of Pittsburgh
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bipolar Disorder
Intervention: lithium carbonate (Drug); Depakote-ER (Drug); risperidone (Drug); olanzapine (Drug); paroxetine (Drug); bupropion (Drug); lamotrigine (Drug); venlafaxine (Drug); tranylcypromine (Drug); mirtazapine (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: University of Pittsburgh Official(s) and/or principal investigator(s):
Charles F Reynolds III, MD, Principal Investigator, Affiliation: University of Pittsburgh
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.
Clinical Details
Official title: Treatment of Geriatric Bipolar Mood Disorders: A Pilot Study
Study design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Primary outcome: 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 of affective symptoms, functional status, side effects, and cognition tracked over acute, continuation, and maintenance phases of treatment.
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
Minimum age: 60 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania 15213, United States
University of Pittsubrgh Medical Center, Pittsburgh, Pennsylvania 15213, United States
Additional Information
An online resource for older individuals with mental health needs
Starting date: July 2001
Ending date: January 2004
Last updated: September 13, 2005
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