Preventing Post-Stroke Depression

Study Overview
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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.

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.

Official Title
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Prevention of Post-Stroke Depression - Treatment Strategy

Conditions
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Depression, Cerebrovascular Accident

Intervention / Treatment
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* Behavioral: Problem Solving Therapy
* Drug: Escitalopram
* Other: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 31 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1 Problem Solving Therapy<br>Participants will receive problem solving therapy. | Behavioral: Problem Solving Therapy<br>* Problem solving therapy aims to make patients aware of symptoms of problems and link those with behaviors associated with solving them.<br>|
| Experimental: 2. Escitalopram<br>Participants will receive escitalopram. | Drug: Escitalopram<br>* Participants will receive escitalopram, a selective serotonin reuptake inhibitor.<br>* Other names: Lexapro;|
| Placebo Comparator: 3 Placebo<br>Participants will receive placebo. | Other: Placebo<br>* Participants will receive a placebo pill.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of depressive disorders in the study population |  | Measured at baseline, Week 6, and Months 3, 6, 9, 12, and 18 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke