Preventing Post-Stroke Depression - Tabular View

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Preventing Post-Stroke Depression

This study is ongoing, but not recruiting participants.

Study NCT00071643. Last updated on August 20, 2008. Information provided by National Institute of Mental Health (NIMH)

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields
Brief Title ^†	Preventing Post-Stroke Depression
Official Title ^†	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 ^†	Interventional
Study Design ^†	Prevention, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
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 ]
Secondary Outcome Measure ^†	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 ]
Condition ^†	Depression Cerebrovascular Accident
Intervention ^†	Behavioral: Problem Solving Therapy Drug: Escitalopram Other: Placebo
MEDLINE PMIDs
Links

Recruitment Information Fields
Recruitment Status ^†	Active, not recruiting
Enrollment ^†	201
Start Date ^†	September 2002
Completion Date
Eligibility Criteria ^†	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 ^††
Location Countries ^†	United States

Administrative Information Fields
NCT ID ^†	NCT00071643
Organization ID	R01 MH65134
Secondary IDs ^††	DATR A4-GPX
Study Sponsor ^†	National Institute of Mental Health (NIMH)
Collaborators ^††
Investigators ^†
Information Provided By	National Institute of Mental Health (NIMH)
Verification Date	August 2008
First Received Date ^†	October 29, 2003
Last Updated Date	August 20, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.