Clinical trial NCT00071643: Preventing Post-Stroke Depression
Official title: Prevention of Post-Stroke Depression - Treatment Strategy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Cerebrovascular Accident
Keywords: Stroke
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2003-10-30
Enrollment: 201
Sex: ALL
Minimum age (years): 31
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of depressive disorders in the study population
timeFrame: Measured at baseline, Week 6, and Months 3, 6, 9, 12, and 18
Secondary outcomes:
measure: Functional Independence Measure
timeFrame: Measured at baseline, at Week 6, and at Months 3, 6, 9, 12, and 18
measure: Stroke Impact Scale
timeFrame: Measured at baseline, Week 6, and Months 3, 6, 9, 12, and 18
measure: Neurocognitive tests of executive functions and speed of information processing
timeFrame: Measured at baseline and after 12 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: White Plains
country: United States
facility: Burke Rehabilitation Hospital
state: New York
Study officials:
References:
citation: Mikami K, Jorge RE, Moser DJ, Arndt S, Jang M, Solodkin A, Small SL, Fonzetti P, Hegel MT, Robinson RG. Increased frequency of first-episode poststroke depression after discontinuation of escitalopram. Stroke. 2011 Nov;42(11):3281-3. doi: 10.1161/STROKEAHA.111.626507. Epub 2011 Aug 25.
citation: Jorge RE, Acion L, Moser D, Adams HP Jr, Robinson RG. Escitalopram and enhancement of cognitive recovery following stroke. Arch Gen Psychiatry. 2010 Feb;67(2):187-96. doi: 10.1001/archgenpsychiatry.2009.185.
citation: 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. doi: 10.1001/jama.299.20.2391.