Clinical Trial: Treatment for Post-Stroke Depression

This study is currently recruiting patients.

Sponsored by: National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by: National Institute of Neurological Disorders and Stroke (NINDS)

Purpose

The purpose of this study is to evaluate a program of education, medicine, and monitoring for the treatment of depression after a stroke.

Condition Treatment or Intervention Phase
Stroke
Depression
 Drug: antidepressants
Phase III

MedlinePlus related topics:  Depression;   Stroke

Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind

Further Study Details: 

Expected Total Enrollment:  780

This trial will compare outcomes in depressed patients receiving the Activate-Initiate-Monitor (AIM) intervention vs. those receiving usual care, and will also compare outcomes in depressed and non-depressed stroke survivors. Patients are screened for depression 1 to 2 months post-stroke. Patients with depression are then randomized to the AIM intervention or control group. Patients without depression are also enrolled at the same time and are matched by hospital site to the depressed patients. The AIM intervention is a 3-part program consisting of activating or educating the patient and his/her family about post-stroke depression, instituting treatment for depression, and monitoring antidepressant treatments for side effects, efficacy, and compliance. Control patients are evaluated and treated with usual care by their physicians. Patients without depression do not receive the intervention but complete the same assessments on the same schedule as the patients with depression.

Eligibility

Genders Eligible for Study:  Both

Criteria

  • No severe language or cognitive deficits,
  • life expectancy of at least 9 months, and
  • willingness to participate.

Location and Contact Information

Laurie Plue, M.S.      317-554-0000  Ext. 2351 

Indiana
      Roudebush VA Medical Center, Health Services Research and Development 11H, 1481 W. 10th Street, Indianapolis,  Indiana,  46202,  United States; Recruiting
Laurie Plue, M.S.  317-554-0000  Ext. 2351 
Linda Williams, M.D.,  Principal Investigator

      Indiana University Hospital, 550 N. University Blvd., Indianapolis,  Indiana,  46202,  United States; Recruiting
Laurie Plue, M.S.  317-554-0000  Ext. 2351 
Linda Williams, M.D.,  Principal Investigator

      Methodist Hospital of Indiana, 1601 N. Capitol, Indianapolis,  Indiana,  46202,  United States; Recruiting
Laurie Plue, M.S.  317-554-0000  Ext. 2351 
Linda Williams, M.D.,  Principal Investigator

      Wishard Memorial Hospital, 1001 W. 10th Street, Indianapolis,  Indiana,  46202,  United States; Recruiting
Laurie Plue, M.S.  317-554-0000  Ext. 2351 
Linda Williams, M.D.,  Principal Investigator

Study chairs or principal investigators

Linda Williams, M.D.,  Principal Investigator,  Roudebush VA Medical Center Health Services Research and Development 11H   

More Information

Study ID Numbers:  R01NS39571
Record last reviewed:  October 2004
Last Updated:  October 14, 2004
Record first received:  January 8, 2002
ClinicalTrials.gov Identifier:  NCT00029172
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


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