Preventing Post-Stroke Depression

August 31, 2017 updated by: Robert G. Robinson

Prevention of Post-Stroke Depression - Treatment Strategy

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

201

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago
    • Iowa
      • Iowa City, Iowa, United States, 52242-1000
        • University Of Iowa Hospitals And Clinics
    • New York
      • White Plains, New York, United States, 10605
        • Burke Rehabilitation Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

31 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1 Problem Solving Therapy
Participants will receive problem solving therapy.
Behavioral: Problem Solving Therapy
Problem solving therapy aims to make patients aware of symptoms of problems and link those with behaviors associated with solving them.
Experimental: 2. Escitalopram
Participants will receive escitalopram.
Drug: Escitalopram
Participants will receive escitalopram, a selective serotonin reuptake inhibitor.
Other Names:
  • Lexapro
Placebo Comparator: 3 Placebo
Participants will receive placebo.
Other: Placebo
Participants will receive a placebo pill.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of depressive disorders in the study population
Time Frame: Measured at baseline, Week 6, and Months 3, 6, 9, 12, and 18
Measured at baseline, Week 6, and Months 3, 6, 9, 12, and 18

Secondary Outcome Measures

Outcome Measure
Time Frame
Functional Independence Measure
Time Frame: Measured at baseline, at Week 6, and at Months 3, 6, 9, 12, and 18
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
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
Measured at baseline and after 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Robert G. Robinson

Collaborators

National Institute of Mental Health (NIMH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2002

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

October 29, 2003

First Submitted That Met QC Criteria

October 29, 2003

First Posted (Estimate)

October 30, 2003

Study Record Updates

Last Update Posted (Actual)

September 5, 2017

Last Update Submitted That Met QC Criteria

August 31, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200207091
  • DATR A4-GPX
  • R01MH065134 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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