Preventing Post-Stroke Depression

Not Applicable

Completed

• Conditions: Depression; Cerebrovascular Accident
• Interventions: Behavioral: Problem Solving Therapy; Other: Placebo; Drug: Escitalopram

• Registration Number: NCT00071643
• Lead Sponsor: Robert G. Robinson

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2002-09
• Study First Submitted: 2003-10-29
• Study First Submitted QC: 2003-10-29
• Study First Posted: 2003-10-30
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-31
• Last Update Posted: 2017-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 201

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1 Problem Solving Therapy	Problem Solving Therapy	Participants will receive problem solving therapy.
3 Placebo	Placebo	Participants will receive placebo.
2. Escitalopram	Escitalopram	Participants will receive escitalopram.

Primary Outcome Measures

Name	Time	Method
Incidence of depressive disorders in the study population	Measured at baseline, Week 6, and Months 3, 6, 9, 12, and 18

Secondary Outcome Measures

Name	Time	Method
Functional Independence Measure	Measured at baseline, at Week 6, and at Months 3, 6, 9, 12, and 18
Stroke Impact Scale	Measured at baseline, Week 6, and Months 3, 6, 9, 12, and 18
Neurocognitive tests of executive functions and speed of information processing	Measured at baseline and after 12 months

Trial Locations

Locations (3)

University of Iowa Hospitals and Clinics; 🇺🇸 Iowa City, Iowa, United States

Burke Rehabilitation Hospital; 🇺🇸 White Plains, New York, United States

University of Chicago; 🇺🇸 Chicago, Illinois, United States