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Preventing Post-Stroke Depression
This study is ongoing, but not recruiting participants.
Study NCT00071643   Information provided by National Institute of Mental Health (NIMH)
First Received: October 29, 2003   Last Updated: August 20, 2008   History of Changes

October 29, 2003
August 20, 2008
September 2002
November 2008   (final data collection date for 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 ]
Same as current
Complete list of historical versions of study NCT00071643 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
 
Preventing Post-Stroke Depression
Prevention of Post-Stroke Depression - Treatment Strategy

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

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.

Phase III
Interventional
Prevention, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
  • Depression
  • Cerebrovascular Accident
  • Behavioral: Problem Solving Therapy
  • Drug: Escitalopram
  • Other: Placebo
  • Experimental: Participants will receive problem solving therapy.
  • Experimental: Participants will receive escitalopram.
  • Placebo Comparator: Participants will receive placebo.
Robinson RG, Jorge RE, Moser DJ, Acion L, Solodkin A, Small SL, Fonzetti P, Hegel M, Arndt S. Escitalopram and problem-solving therapy for prevention of poststroke depression: a randomized controlled trial. JAMA. 2008 May 28;299(20):2391-400.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
201
 
November 2008   (final data collection date for primary outcome measure)

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
Both
31 Years to 89 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00071643
Robert G. Robinson, MD, University of Iowa
R01 MH65134, DATR A4-GPX
National Institute of Mental Health (NIMH)
 
 
National Institute of Mental Health (NIMH)
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP