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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2013 by University of Iowa.
Recruitment status was  Active, not recruiting
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Robert G. Robinson, University of Iowa Identifier:
First received: October 29, 2003
Last updated: July 1, 2013
Last verified: July 2013
This study will evaluate the effectiveness of both drug and non-drug treatments in preventing depression after a stroke.

Condition Intervention Phase
Cerebrovascular Accident
Behavioral: Problem Solving Therapy
Drug: Escitalopram
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prevention of Post-Stroke Depression - Treatment Strategy

Resource links provided by NLM:

Further study details as provided by University of Iowa:

Primary Outcome Measures:
  • Incidence of depressive disorders in the study population [ Time Frame: Measured at baseline, Week 6, and Months 3, 6, 9, 12, and 18 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Functional Independence Measure [ Time Frame: Measured at baseline, at Week 6, and at Months 3, 6, 9, 12, and 18 ] [ Designated as safety issue: No ]
  • Stroke Impact Scale [ Time Frame: Measured at baseline, Week 6, and Months 3, 6, 9, 12, and 18 ] [ Designated as safety issue: No ]
  • Neurocognitive tests of executive functions and speed of information processing [ Time Frame: Measured at baseline and after 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 201
Study Start Date: September 2002
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.


Ages Eligible for Study:   31 Years to 89 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00071643

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
University of Iowa
National Institute of Mental Health (NIMH)
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Robert G. Robinson, Professor, University of Iowa Identifier: NCT00071643     History of Changes
Other Study ID Numbers: R01MH065134  DATR A4-GPX 
Study First Received: October 29, 2003
Last Updated: July 1, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Iowa:

Additional relevant MeSH terms:
Depressive Disorder
Behavioral Symptoms
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Mental Disorders
Mood Disorders
Nervous System Diseases
Vascular Diseases
Anti-Dyskinesia Agents
Antidepressive Agents
Antidepressive Agents, Second-Generation
Antiparkinson Agents
Autonomic Agents
Cholinergic Agents
Cholinergic Antagonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Physiological Effects of Drugs
Psychotropic Drugs processed this record on May 26, 2016