This trial is active, not recruiting.

Conditions depression, cerebrovascular accident
Treatments problem solving therapy, escitalopram, placebo
Phase phase 3
Sponsor University of Iowa
Collaborator National Institute of Mental Health (NIMH)
Start date September 2002
End date November 2008
Trial size 201 participants
Trial identifier NCT00071643, DATR A4-GPX, R01 MH65134, R01MH065134


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, outcomes assessor)
Primary purpose prevention
Participants will receive problem solving therapy.
problem solving therapy
Problem solving therapy aims to make patients aware of symptoms of problems and link those with behaviors associated with solving them.
Participants will receive escitalopram.
escitalopram Lexapro
Participants will receive escitalopram, a selective serotonin reuptake inhibitor.
(Placebo Comparator)
Participants will receive placebo.
Participants will receive a placebo pill.

Primary Outcomes

Incidence of depressive disorders in the study population
time frame: Measured at baseline, Week 6, and Months 3, 6, 9, 12, and 18

Secondary Outcomes

Functional Independence Measure
time frame: Measured at baseline, at Week 6, and at Months 3, 6, 9, 12, and 18
Stroke Impact Scale
time frame: Measured at baseline, Week 6, and Months 3, 6, 9, 12, and 18
Neurocognitive tests of executive functions and speed of information processing
time frame: Measured at baseline and after 12 months

Eligibility Criteria

Male or female participants from 31 years up to 89 years old.

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

Additional Information

Official title Prevention of Post-Stroke Depression - Treatment Strategy
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2013.
Information provided to ClinicalTrials.gov by University of Iowa.