Preventing Post-Stroke Depression

Robert G. Robinson

Status: Completed

Conditions: Cerebrovascular Accident; Depression

Treatments: Other: Placebo; Drug: Escitalopram; Behavioral: Problem Solving Therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00071643

DATR A4-GPX

200207091

R01MH065134 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 201 patients

Sex: All

Ages: 31 to 89 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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201 participants in 3 patient groups, including a placebo group

1 Problem Solving Therapy

Experimental group

Description:

Participants will receive problem solving therapy.

Treatment:

Behavioral: Problem Solving Therapy

2. Escitalopram

Experimental group

Description:

Participants will receive escitalopram.

Treatment:

Drug: Escitalopram

3 Placebo

Placebo Comparator group

Description:

Participants will receive placebo.

Treatment:

Other: Placebo