search
Back to results

Preventing Post-Stroke Depression

Primary Purpose

Depression, Cerebrovascular Accident

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Problem Solving Therapy
Escitalopram
Placebo
Sponsored by
Robert G. Robinson
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Depression focused on measuring Stroke

Eligibility Criteria

31 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Chicago
  • University of Iowa Hospitals and Clinics
  • Burke Rehabilitation Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

1 Problem Solving Therapy

2. Escitalopram

3 Placebo

Arm Description

Participants will receive problem solving therapy.

Participants will receive escitalopram.

Participants will receive placebo.

Outcomes

Primary Outcome Measures

Incidence of depressive disorders in the study population

Secondary Outcome Measures

Functional Independence Measure
Stroke Impact Scale
Neurocognitive tests of executive functions and speed of information processing

Full Information

First Posted
October 29, 2003
Last Updated
August 31, 2017
Sponsor
Robert G. Robinson
Collaborators
National Institute of Mental Health (NIMH)
search

1. Study Identification

Unique Protocol Identification Number
NCT00071643
Brief Title
Preventing Post-Stroke Depression
Official Title
Prevention of Post-Stroke Depression - Treatment Strategy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Robert G. Robinson
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Cerebrovascular Accident
Keywords
Stroke

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
201 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1 Problem Solving Therapy
Arm Type
Experimental
Arm Description
Participants will receive problem solving therapy.
Arm Title
2. Escitalopram
Arm Type
Experimental
Arm Description
Participants will receive escitalopram.
Arm Title
3 Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo.
Intervention Type
Behavioral
Intervention Name(s)
Problem Solving Therapy
Intervention Description
Problem solving therapy aims to make patients aware of symptoms of problems and link those with behaviors associated with solving them.
Intervention Type
Drug
Intervention Name(s)
Escitalopram
Other Intervention Name(s)
Lexapro
Intervention Description
Participants will receive escitalopram, a selective serotonin reuptake inhibitor.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Participants will receive a placebo pill.
Primary Outcome Measure Information:
Title
Incidence of depressive disorders in the study population
Time Frame
Measured at baseline, Week 6, and Months 3, 6, 9, 12, and 18
Secondary Outcome Measure Information:
Title
Functional Independence Measure
Time Frame
Measured at baseline, at Week 6, and at Months 3, 6, 9, 12, and 18
Title
Stroke Impact Scale
Time Frame
Measured at baseline, Week 6, and Months 3, 6, 9, 12, and 18
Title
Neurocognitive tests of executive functions and speed of information processing
Time Frame
Measured at baseline and after 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
31 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242-1000
Country
United States
Facility Name
Burke Rehabilitation Hospital
City
White Plains
State/Province
New York
ZIP/Postal Code
10605
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21868736
Citation
Mikami K, Jorge RE, Moser DJ, Arndt S, Jang M, Solodkin A, Small SL, Fonzetti P, Hegel MT, Robinson RG. Increased frequency of first-episode poststroke depression after discontinuation of escitalopram. Stroke. 2011 Nov;42(11):3281-3. doi: 10.1161/STROKEAHA.111.626507. Epub 2011 Aug 25.
Results Reference
derived
PubMed Identifier
20124118
Citation
Jorge RE, Acion L, Moser D, Adams HP Jr, Robinson RG. Escitalopram and enhancement of cognitive recovery following stroke. Arch Gen Psychiatry. 2010 Feb;67(2):187-96. doi: 10.1001/archgenpsychiatry.2009.185.
Results Reference
derived
PubMed Identifier
18505948
Citation
Robinson RG, Jorge RE, Moser DJ, Acion L, Solodkin A, Small SL, Fonzetti P, Hegel M, Arndt S. Escitalopram and problem-solving therapy for prevention of poststroke depression: a randomized controlled trial. JAMA. 2008 May 28;299(20):2391-400. doi: 10.1001/jama.299.20.2391. Erratum In: JAMA. 2009 Mar 11;301(10):1024.
Results Reference
derived

Learn more about this trial

Preventing Post-Stroke Depression

We'll reach out to this number within 24 hrs