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Trial record 1 of 1 for:    NCT00071643
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Preventing Post-Stroke Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00071643
Recruitment Status : Completed
First Posted : October 30, 2003
Last Update Posted : September 5, 2017
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Robert G. Robinson, University of Iowa

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

Condition or disease Intervention/treatment Phase
Depression Cerebrovascular Accident Behavioral: Problem Solving Therapy Drug: Escitalopram Other: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 201 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prevention of Post-Stroke Depression - Treatment Strategy
Study Start Date : September 2002
Actual Primary Completion Date : November 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1 Problem Solving Therapy
Participants will receive problem solving therapy.
Behavioral: Problem Solving Therapy
Problem solving therapy aims to make patients aware of symptoms of problems and link those with behaviors associated with solving them.

Experimental: 2. Escitalopram
Participants will receive escitalopram.
Drug: Escitalopram
Participants will receive escitalopram, a selective serotonin reuptake inhibitor.
Other Name: Lexapro

Placebo Comparator: 3 Placebo
Participants will receive placebo.
Other: Placebo
Participants will receive a placebo pill.

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   31 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00071643

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United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242-1000
United States, New York
Burke Rehabilitation Hospital
White Plains, New York, United States, 10605
Sponsors and Collaborators
Robert G. Robinson
National Institute of Mental Health (NIMH)
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Robert G. Robinson, Professor, University of Iowa Identifier: NCT00071643    
Other Study ID Numbers: 200207091
R01MH065134 ( U.S. NIH Grant/Contract )
First Posted: October 30, 2003    Key Record Dates
Last Update Posted: September 5, 2017
Last Verified: August 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Robert G. Robinson, University of Iowa:
Additional relevant MeSH terms:
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Depressive Disorder
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Behavioral Symptoms
Mood Disorders
Mental Disorders
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs