Cerebrovascular Accident, Depression
Conditions
Keywords
Stroke
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.
Interventions
BEHAVIORALProblem Solving Therapy
Problem solving therapy aims to make patients aware of symptoms of problems and link those with behaviors associated with solving them.
DRUGEscitalopram
Participants will receive escitalopram, a selective serotonin reuptake inhibitor.
OTHERPlacebo
Participants will receive a placebo pill.
Sponsors
National Institute of Mental Health (NIMH)
Robert G. Robinson
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
31 Years to 89 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of depressive disorders in the study population | Measured at baseline, Week 6, and Months 3, 6, 9, 12, and 18 |
Secondary
| Measure | Time frame |
|---|---|
| Functional Independence Measure | Measured at baseline, at Week 6, and at Months 3, 6, 9, 12, and 18 |
| Stroke Impact Scale | Measured at baseline, Week 6, and Months 3, 6, 9, 12, and 18 |
| Neurocognitive tests of executive functions and speed of information processing | Measured at baseline and after 12 months |
Countries
United States
Outcome results
None listed