Completed

Prevention of Post-Stroke Depression - Treatment Strategy

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Problem Solving Therapy

+ Escitalopram

+ Placebo

BehavioralDrugOther
Who is being recruted

Mental Disorders+9

+ Behavioral Symptoms

+ Brain Diseases

From 31 to 89 Years
See all eligibility criteria
How is the trial designed

Prevention Study

Placebo-Controlled
Interventional
Study Start: September 2002
See protocol details

Summary

Principal SponsorRobert G. Robinson
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2002

Actual date on which the first participant was enrolled.

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.

Official TitlePrevention of Post-Stroke Depression - Treatment Strategy 
NCT00071643
Principal SponsorRobert G. Robinson
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

201 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 31 to 89 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Mental DisordersBehavioral SymptomsBrain DiseasesCardiovascular DiseasesCentral Nervous System DiseasesCerebrovascular DisordersDepressionDepressive DisorderNervous System DiseasesVascular DiseasesMood DisordersStroke

Criteria

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 Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Participants will receive problem solving therapy.

Group II

Experimental
Participants will receive escitalopram.

Group III

Placebo
Participants will receive placebo.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

Suspended

University of Chicago

Chicago, United StatesSee the location
Suspended

University of Iowa Hospitals and Clinics

Iowa City, United States
Suspended

Burke Rehabilitation Hospital

White Plains, United States
Completed3 Study Centers