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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


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 Performance

Cognitive 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


Minimum age: 65 Years. Maximum age: N/A. Gender(s): Both.


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

Page last updated: August 23, 2015

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