Antidepressant Medication Plus Donepezil for Treating Late-life Depression

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-12-31

Study Completion Date

2009-09-30

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Depression Dementia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1

escitalopram plus donepezil (DNP)in the experimental maintenance phase of the study.

For subjects failing to respond to escitalopram during the initial open phase of acute treatment we allowed the use of duloxetine or venlafaxine to bring about remission and establish eligibility for randomized assignment to maintenance treatment with augmentation donepezil.

Participants remained on the same antidepressant medication and dosage throughout the 2 year maintenance phase of the study. In the event of a recurrence of major depression during maintenance treatment, dosages of antidepressant medication were raised, or the antidepressant was switched to venlafaxine or duloxetine.

For subjects failing to respond to escitalopram during the initial open phase of acute treatment, we allowed the use of duloxetine to bring about remission and establish eligibility for randomized assignment to maintenance treatment with augmentation placebo.

Group Type EXPERIMENTAL

Escitalopram

Intervention Type DRUG

Escitalopram, 10mg to 20mg daily.

Donepezil

Intervention Type DRUG

Donepezil, 5mg to 10mg daily.

Venlafaxine

Intervention Type DRUG

Venlafaxine, 150mg to 300mg daily.

Duloxetine

Intervention Type DRUG

2

escitalopram plus placebo (PBO) in the experimental maintenance phase of the study.

For subjects failing to respond to escitalopram during the initial open phase of acute treatment, we allowed the use of duloxetine or venlafaxine to bring about remission and establish eligibility for randomized assignment to maintenance treatment with augmentation placebo.

Participants remained on the same antidepressant medication and dosage throughout the 2 year maintenance phase of the study. In the event of a recurrence of major depression during maintenance treatment, dosages of antidepressant medication were raised, or the antidepressant was switched to venlafaxine or duloxetine.

For subjects failing to respond to escitalopram during the initial open phase of acute treatment, we allowed the use of venlafaxine or duloxetine to bring about remission and establish eligibility for randomized assignment to maintenance treatment with augmentation placebo.

Group Type PLACEBO_COMPARATOR

Escitalopram

Intervention Type DRUG

Escitalopram, 10mg to 20mg daily.

Venlafaxine

Intervention Type DRUG

Venlafaxine, 150mg to 300mg daily.

Placebo

Intervention Type DRUG

Duloxetine

Intervention Type DRUG

Interventions

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Escitalopram

Escitalopram, 10mg to 20mg daily.

Intervention Type DRUG

Donepezil

Donepezil, 5mg to 10mg daily.

Intervention Type DRUG

Venlafaxine

Venlafaxine, 150mg to 300mg daily.

Intervention Type DRUG

Placebo

Intervention Type DRUG

Duloxetine

Intervention Type DRUG

Other Intervention Names

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Lexapro aricept effexor XR cymbalta

Eligibility Criteria

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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

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes