Antidepressant Medication Plus Donepezil for Treating Late-life Depression
Information source: University of Pittsburgh
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Depression; Dementia
Intervention: Escitalopram (Drug); Donepezil (Drug); Venlafaxine (Drug); Placebo (Drug); Duloxetine (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: University of Pittsburgh Official(s) and/or principal investigator(s): Bruce G. Pollock, MD, PhD, Principal Investigator, Affiliation: University of Pittsburgh Professor of Psychiatry, Pharmacology, and Nursing
Summary
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.
Clinical Details
Official title: Maintenance Therapies in Late-Life Depression: MTLD III
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Global Cognitive PerformanceCognitive Instrumental Activities of Daily Living (IADL) Number of Participants With Recurrence of Major Depression
Detailed description:
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
Minimum age: 65 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Current episode of major depression
- HRS-D 17-item score of 15 or higher
- Must be able to speak English
- Willing to discontinue other psychotropics
- Availability of family member/caregiver
- Hearing capacity adequate to respond to raised conversational voice
- Must have no formal diagnosis of dementia
Exclusion Criteria:
- Meets DSM-IV criteria for bipolar disorder, schizophrenia, schizoaffective disorder,
or a psychotic disorders
- Alcohol/drug abuse within 12 months of study entry
- History of treatment non-adherence in other clinic protocols
- History of non-response to citalopram in other clinic protocols
- History of non-tolerance to SSRI therapy
Locations and Contacts
University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania 15213, United States
Additional Information
An online resource for older individuals with mental health problems and their families.
Related publications: Reynolds CF 3rd, Butters MA, Lopez O, Pollock BG, Dew MA, Mulsant BH, Lenze EJ, Holm M, Rogers JC, Mazumdar S, Houck PR, Begley A, Anderson S, Karp JF, Miller MD, Whyte EM, Stack J, Gildengers A, Szanto K, Bensasi S, Kaufer DI, Kamboh MI, DeKosky ST. Maintenance treatment of depression in old age: a randomized, double-blind, placebo-controlled evaluation of the efficacy and safety of donepezil combined with antidepressant pharmacotherapy. Arch Gen Psychiatry. 2011 Jan;68(1):51-60. doi: 10.1001/archgenpsychiatry.2010.184.
Starting date: December 2003
Last updated: January 31, 2013
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