Clinical Trial: Preventing Post-Stroke Depression

This study is currently recruiting patients.

Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)

Purpose

The purpose of this study is to evaluate the effectiveness of both drug and nondrug treatments in preventing depression after a stroke.

Condition Treatment or Intervention Phase
Depression
Cerebrovascular Accident
 Behavior: Problem Solving Therapy
 Drug: Escitalopram
Phase III

MedlinePlus related topics:  Depression;   Stroke

Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Official Title: Prevention of Post-Stroke Depression - Treatment Strategy

Further Study Details: 

Expected Total Enrollment:  201

Study start: September 2002

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

Ages Eligible for Study:  31 Years   -   89 Years,  Genders Eligible for Study:  Both

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

Location and Contact Information


Illinois
      University of Chicago, Chicago,  Illinois,  60637,  United States; Recruiting
Ana Solodkin, MD  773-834-7706    solodkin@uchicago.edu 

Iowa
      University of Iowa Hospitals and Clinics, Iowa City,  Iowa,  52242-1000,  United States; Recruiting
Stephanie Rosazza, RAIII  319-353-5807    stephanie-rosazza@uiowa.edu 
Robert G. Robinson, MD,  Principal Investigator
Ricardo E. Jorge, MD,  Sub-Investigator

New York
      Burke Rehabilitation Hospital, White Plains,  New York,  10605,  United States; Recruiting
Mireya Montaban-Panzer  914-597-2827    mmontalv@burke.org 

More Information

Study ID Numbers:  65134-01A1
Record last reviewed:  March 2005
Last Updated:  March 24, 2005
Record first received:  October 29, 2003
ClinicalTrials.gov Identifier:  NCT00071643
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005