Treatment of Geriatric Bipolar Mood Disorders: A Pilot Study
This study has been completed.
Sponsor:
University of Pittsburgh
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
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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:
Drug Information available for:
Valproic acid
Lithium carbonate
Valproate sodium
Lithium citrate
Tranylcypromine sulfate
Bupropion hydrochloride
Bupropion
Paroxetine
Divalproex sodium
Paroxetine hydrochloride
Lamotrigine
Mirtazapine
Venlafaxine
Venlafaxine hydrochloride
Risperidone
Paroxetine hydrochloride hemihydrate
Olanzapine
Paroxetine Mesylate
Olanzapine pamoate
U.S. FDA Resources
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 |
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
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 Affective Disorders, Psychotic Mental Disorders Lamotrigine Valproic Acid Lithium Carbonate Tranylcypromine Lithium Mirtazapine Paroxetine Risperidone Venlafaxine Bupropion Olanzapine |
Anticonvulsants Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action GABA Agents Neurotransmitter Agents Physiological Effects of Drugs Antimanic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Antipsychotic Agents Antidepressive Agents |
ClinicalTrials.gov processed this record on June 18, 2013