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Preventing Post-Stroke Depression

This study is currently recruiting participants.
Verified by National Institute of Mental Health (NIMH), February 2007

Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00071643
  Purpose

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


Condition Intervention Phase
Depression
Cerebrovascular Accident
Behavioral: Problem Solving Therapy
Drug: Escitalopram
Phase III

Genetics Home Reference related topics:   Stroke  

MedlinePlus related topics:   Depression  

ChemIDplus related topics:   Escitalopram   Benzetimide   Citalopram   Citalopram hydrobromide   Dexetimide   Escitalopram oxalate  

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:   Prevention of Post-Stroke Depression - Treatment Strategy

Further study details as provided by National Institute of Mental Health (NIMH):

Estimated Enrollment:   201
Study Start Date:   September 2002

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.

  Eligibility
Ages Eligible for Study:   31 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Stroke within the last 120 days

Exclusion Criteria:

  • DSM 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00071643

Locations
United States, Illinois
University of Chicago     Active, not recruiting
      Chicago, Illinois, United States, 60637
United States, Iowa
University of Iowa Hospitals and Clinics     Recruiting
      Iowa City, Iowa, United States, 52242-1000
      Contact: Stephanie Rosazza, RAIII     319-353-5807     stephanie-rosazza@uiowa.edu    
      Principal Investigator: Robert G. Robinson, MD            
      Sub-Investigator: Ricardo E. Jorge, MD            
United States, New York
Burke Rehabilitation Hospital     Active, not recruiting
      White Plains, New York, United States, 10605

Sponsors and Collaborators
  More Information

Publications indexed to this study:

Study ID Numbers:   R01 MH65134, DATR A4-GPX
First Received:   October 29, 2003
Last Updated:   February 6, 2007
ClinicalTrials.gov Identifier:   NCT00071643
Health Authority:   United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Stroke  

Study placed in the following topic categories:
Depression
Cerebral Infarction
Stroke
Vascular Diseases
Central Nervous System Diseases
Ischemia
Depressive Disorder
Brain Diseases
Citalopram
Cerebrovascular Disorders
Serotonin
Mood Disorders
Brain Ischemia
Brain Infarction
Dexetimide
Infarction

Additional relevant MeSH terms:
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Nervous System Diseases
Psychotropic Drugs
Serotonin Uptake Inhibitors
Pharmacologic Actions
Behavioral Symptoms
Serotonin Agents
Mental Disorders
Therapeutic Uses
Cardiovascular Diseases
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on July 03, 2008




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