Preventing Post-Stroke Depression

Sponsor

Robert G. Robinson (Other)

Overall Status

Completed

CT.gov ID

NCT00071643

Collaborator

National Institute of Mental Health (NIMH) (NIH)

201

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Depression Cerebrovascular Accident	Behavioral: Problem Solving Therapy Drug: Escitalopram Other: Placebo	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

201 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Prevention of Post-Stroke Depression - Treatment Strategy

Study Start Date :

Sep 1, 2002

Actual Primary Completion Date :

Nov 1, 2008

Actual Study Completion Date :

Nov 1, 2008

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Incidence of depressive disorders in the study population [Measured at baseline, Week 6, and Months 3, 6, 9, 12, and 18]

Secondary Outcome Measures

Functional Independence Measure [Measured at baseline, at Week 6, and at Months 3, 6, 9, 12, and 18]
Stroke Impact Scale [Measured at baseline, Week 6, and Months 3, 6, 9, 12, and 18]
Neurocognitive tests of executive functions and speed of information processing [Measured at baseline and after 12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

31 Years to 89 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Chicago	Chicago	Illinois	United States	60637
2	University of Iowa Hospitals and Clinics	Iowa City	Iowa	United States	52242-1000
3	Burke Rehabilitation Hospital	White Plains	New York	United States	10605

Sponsors and Collaborators

Robert G. Robinson
National Institute of Mental Health (NIMH)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Robert G. Robinson, Professor, University of Iowa

ClinicalTrials.gov Identifier:

NCT00071643

Other Study ID Numbers:

200207091
R01MH065134
DATR A4-GPX

First Posted:

Oct 30, 2003

Last Update Posted:

Sep 5, 2017

Last Verified:

Aug 1, 2017

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Robert G. Robinson, Professor, University of Iowa

Stroke

Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 5, 2017