Preventing Post-Stroke Depression

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

201 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-09-30

Study Completion Date

2008-11-30

Brief Summary

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This study will evaluate the effectiveness of both drug and non-drug treatments in preventing depression after a stroke.

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Detailed Description

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The development of depression after a stroke is a serious condition that can have negative effects on thought, emotions, and overall daily functioning, particularly in the first year following the stroke. Evidence suggests that antidepressants may be used to prevent post-stroke depression. This study will treat nondepressed stroke patients with antidepressants or problem solving therapy (PST) to determine the most effective treatments for preventing depression.

Participants in this study will be randomly assigned to receive PST, escitalopram, or placebo (an inactive pill) for 12 months. Participants who display depressive symptoms for 2 weeks or more will be removed from the study. After 12 months, treatment will be discontinued and participants will be monitored for an additional 6 months.

Conditions

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Depression Cerebrovascular Accident

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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1 Problem Solving Therapy

Participants will receive problem solving therapy.

Group Type EXPERIMENTAL

Problem Solving Therapy

Intervention Type BEHAVIORAL

Problem solving therapy aims to make patients aware of symptoms of problems and link those with behaviors associated with solving them.

2. Escitalopram

Participants will receive escitalopram.

Group Type EXPERIMENTAL

Escitalopram

Intervention Type DRUG

Participants will receive escitalopram, a selective serotonin reuptake inhibitor.

3 Placebo

Participants will receive placebo.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Participants will receive a placebo pill.

Interventions

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Problem Solving Therapy

Problem solving therapy aims to make patients aware of symptoms of problems and link those with behaviors associated with solving them.

Intervention Type BEHAVIORAL

Escitalopram

Participants will receive escitalopram, a selective serotonin reuptake inhibitor.

Intervention Type DRUG

Placebo

Participants will receive a placebo pill.

Intervention Type OTHER

Other Intervention Names

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Lexapro

Eligibility Criteria

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Inclusion Criteria

* Stroke within the last 120 days

Exclusion Criteria

* DSM (Diagnostic and Statistical Manual) IV criteria for major or minor depressive disorder
* Heart, respiratory, kidney, or liver failure; severely disabling musculoskeletal disorder; or cancer
* Diagnosis of neurodegenerative disorders such as Parkinson's disease, Alzheimer's disease, Multiple System Atrophy, or Huntington's disease
* Pre-existing dementia or aphasia with severe language comprehension deficits
* Alcohol or substance abuse or dependence within the last 12 months
* Recurrent unipolar or bipolar disorder prior to the stroke

Minimum Eligible Age

31 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No