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Completed

NCT Number: NCT00071643

Preventing Post-Stroke Depression

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

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Key information

Conditions

Depression Behavior Behavioral Symptoms Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Accident Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

31 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Chicago, Chicago, Illinois, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Problem solving therapy

Behavioral

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

Escitalopram

Drug

Participants will receive escitalopram, a selective serotonin reuptake inhibitor.

Other names: Lexapro

Placebo

Other

Participants will receive a placebo pill.

Primary outcomes

  1. 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

  1. Functional Independence Measure

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

  2. Stroke Impact Scale

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

  3. Neurocognitive tests of executive functions and speed of information processing

    Time frame: Measured at baseline and after 12 months

Sponsors and collaborators

Lead sponsor

Robert G. Robinson

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Prevention of Post-Stroke Depression - Treatment Strategy

Important dates

Study start
2002
Primary completion
2008
Study completion
2008
First posted
Oct 30, 2003
Registry last updated
Sep 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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