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| Sponsors and Collaborators: |
National Institute of Mental Health (NIMH) University of Pittsburgh |
|---|---|
| Information provided by: | National Institute of Mental Health (NIMH) |
| ClinicalTrials.gov Identifier: | NCT00177671 |
Purpose
This study will determine the effectiveness of combining escitalopram, venlafaxine, or duloxetine with donepezil, a medication used in Alzheimer's disease, in improving memory, concentration, attention, and problem solving abilities, and reducing the risk of depressive relapse in older individuals with depression.
| Condition | Intervention | Phase |
|---|---|---|
|
Depression Dementia |
Drug: Escitalopram, duloxetine, or venlafaxine plus donepezil Drug: Antidepressant medication plus placebo |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study |
| Official Title: | Maintenance Therapies in Late-Life Depression: MTLD III |
| Estimated Enrollment: | 250 |
| Study Start Date: | December 2003 |
| Estimated Study Completion Date: | October 2009 |
| Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Participants will receive treatment with antidepressants (escitalopram, venlafaxine, duloxetine) plus donepezil
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Drug: Escitalopram, duloxetine, or venlafaxine plus donepezil
Dosage varies. Participant remains on an antidepressant throughout the study.
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2: Placebo Comparator
Participants will receive treatment with antidepressants (escitalopram, venlafaxine, duloxetine) plus placebo
|
Drug: Antidepressant medication plus placebo
Participant intially undergoes the same antidepressant treatment (escitalopram, venlafaxine, duloxetine) as the experimental group, but switches to placebo.
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The purpose of this research study is to learn if combining an antidepressant medication (escitalopram, venlafaxine, or duloxetine) with a medication used in Alzheimer's Disease (donepezil), in elderly patients age 65 and older with major depression, will help to 1) improve and/or maintain memory, concentration, attention, and problem solving abilities such as ability to balance a checkbook, pay bills, use the telephone, and 2) reduce the risk of depressive symptoms from returning. Study participation will last up to two years.
We aim to investigate pharmacologic strategies for improving and stabilizing cognitive functioning in late-life depression and minimizing progression of cognitive and associated functional impairment. Cognitive impairment in late-life depression has not been adequately addressed in previous intervention research, is a core feature of the illness, contributes markedly to disability and impaired quality of life, and is an overlooked but potentially critical target of intervention. Data from the MTLD II study suggest that treating depression does not normalize cognitive functions and may not prevent their progression. We will test a pharmacologic strategy involving the cholinesterase inhibitor donepezil, in combination with maintenance antidepressant pharmacotherapy (escitalopram, venlafaxine, or duloxetine), to improve and to maintain cognitive functioning and functional competence in elderly patients with major depression.
We hypothesize that maintenance antidepressant pharmacotherapy combined with donepezil will be superior to maintenance antidepressant pharmacotherapy combined with placebo/clinical management in (1) improving cognitive performance; and (2) slowing progression of cognitive impairment and decline in functional competence. We plan to recruit 200 patients aged 65 and above in current episodes of major depression. Those who respond to antidepressant pharmacotherapy with citalopram, venlafaxine, or duloxetine will then be randomly assigned on a double-blind basis to one of two 24-month treatments:
1)antidepressant pharmacotherapy plus donepezil/clinical management; or 2)antidepressant pharmacotherapy plus placebo/clinical management.
For information on related studies, please follow these links:
http://clinicaltrials.gov/show/NCT00000377
http://clinicaltrials.gov/show/NCT00178100
Eligibility| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Pennsylvania | |
| University of Pittsburgh Medical Center | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Principal Investigator: | Bruce G. Pollock, MD, PhD | University of Pittsburgh Professor of Psychiatry, Pharmacology, and Nursing |
More Information
| Responsible Party: | University of Pittsburgh ( Charles F. Reynolds III, MD ) |
| Study ID Numbers: | R01 MH043832-03, 0312018, DATR A4-GPS |
| Study First Received: | September 13, 2005 |
| Last Updated: | February 19, 2009 |
| ClinicalTrials.gov Identifier: | NCT00177671 History of Changes |
| Health Authority: | United States: Federal Government |
|
Depression Dementia Alzheimer's Disease Cognitive Donepezil |
Memory Function Elderly Late-Life |
|
Dopamine Uptake Inhibitors Neurotransmitter Agents Adrenergic Agents Cholinergic Antagonists Psychotropic Drugs Brain Diseases Cholinergic Agents Duloxetine Dopamine Mental Disorders Donepezil Venlafaxine Dexetimide Dementia Antidepressive Agents, Second-Generation |
Antidepressive Agents Delirium Nootropic Agents Depression Alzheimer Disease Central Nervous System Diseases Depressive Disorder Serotonin Uptake Inhibitors Citalopram Serotonin Cognition Disorders Behavioral Symptoms Muscarinic Antagonists Cholinesterase Inhibitors Delirium, Dementia, Amnestic, Cognitive Disorders |
|
Dopamine Uptake Inhibitors Parasympatholytics Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Adrenergic Agents Molecular Mechanisms of Pharmacological Action Cholinergic Antagonists Adrenergic Uptake Inhibitors Anti-Dyskinesia Agents Physiological Effects of Drugs Psychotropic Drugs Antiparkinson Agents Cholinergic Agents Brain Diseases Duloxetine |
Mental Disorders Therapeutic Uses Venlafaxine Donepezil Antidepressive Agents, Second-Generation Dementia Dexetimide Antidepressive Agents Nootropic Agents Depression Nervous System Diseases Central Nervous System Diseases Enzyme Inhibitors Depressive Disorder Serotonin Uptake Inhibitors |
