Preventing Post-Stroke Depression - Tabular View

Tracking Information
First Received Date ^ICMJE	October 29, 2003
Last Updated Date	August 20, 2008
Start Date ^ICMJE	September 2002
Estimated Primary Completion Date	November 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 20, 2008)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00071643 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: August 20, 2008)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Preventing Post-Stroke Depression
Official Title ^ICMJE	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 ^ICMJE	Interventional
Study Design ^ICMJE	Prevention, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Condition ^ICMJE	Depression Cerebrovascular Accident
Intervention ^ICMJE	Behavioral: Problem Solving Therapy Drug: Escitalopram Other: Placebo
Study Arms / Comparison Groups	Experimental: Participants will receive problem solving therapy. Experimental: Participants will receive escitalopram. Placebo Comparator: Participants will receive placebo.
Publications *	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.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	201
Completion Date
Estimated Primary Completion Date	November 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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 ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00071643
Responsible Party	Robert G. Robinson, MD, University of Iowa
Study ID Numbers ^ICMJE	R01 MH65134, DATR A4-GPX
Study Sponsor ^ICMJE	National Institute of Mental Health (NIMH)
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	National Institute of Mental Health (NIMH)
Verification Date	August 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP