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Preventing Post-Stroke Depression

This study is ongoing, but not recruiting participants.
Study NCT00071643.   Last updated on August 20, 2008.   Information provided by National Institute of Mental Health (NIMH)

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Descriptive Information Fields
Brief Title  Preventing Post-Stroke Depression
Official Title  Prevention of Post-Stroke Depression - Treatment Strategy
Brief Summary

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

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.

Study Phase Phase III
Study Type  Interventional
Study Design  Prevention, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Primary Outcome Measure  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 Measure  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 ]
Condition  Depression
Cerebrovascular Accident
Intervention  Behavioral: Problem Solving Therapy
Drug: Escitalopram
Other: Placebo
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Active, not recruiting
Enrollment  201
Start Date  September 2002
Completion Date
Eligibility 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
Gender Both
Ages 31 Years to 89 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00071643
Organization ID R01 MH65134
Secondary IDs †† DATR A4-GPX
Study Sponsor  National Institute of Mental Health (NIMH)
Collaborators ††
Investigators 
Information Provided By National Institute of Mental Health (NIMH)
Verification Date August 2008
First Received Date  October 29, 2003
Last Updated Date August 20, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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