Preventing Post-Stroke Depression

Robert G. Robinson201 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

201

Conditions

Depression Cerebrovascular Accident

Interventions

Problem Solving TherapyBEHAVIORAL

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

EscitalopramDRUG

Participants will receive escitalopram, a selective serotonin reuptake inhibitor.

PlaceboOTHER

Participants will receive a placebo pill.

Eligibility

Sex: ALLMin age: 31 YearsMax age: 89 Years

Medical Language ↔ Plain English

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

Locations (3)

University of Chicago

Chicago, Illinois, United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Burke Rehabilitation Hospital

White Plains, New York, United States

Outcomes

Primary Outcomes

Incidence of depressive disorders in the study population

Time frame: Measured at baseline, Week 6, and Months 3, 6, 9, 12, and 18

Secondary Outcomes

Functional Independence Measure

Time frame: Measured at baseline, at Week 6, and at Months 3, 6, 9, 12, and 18

Stroke Impact Scale

Time frame: Measured at baseline, Week 6, and Months 3, 6, 9, 12, and 18

Neurocognitive tests of executive functions and speed of information processing

Time frame: Measured at baseline and after 12 months

Data from ClinicalTrials.gov

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