Preventing Post-Stroke Depression

Depression Clinical Trial

Official title:

Prevention of Post-Stroke Depression - Treatment Strategy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00071643
• Other study ID #: 200207091
• Secondary ID: R01MH065134DATR
• Status: Completed
• Phase: N/A
• First received: October 29, 2003
• Last updated: August 31, 2017
• Start date: September 2002
• Est. completion date: November 2008

Study information

• Verified date: August 2017
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 31 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebrovascular Accident
• Depression
• Depressive Disorder
• Stroke

Intervention

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.

Drug:
• Escitalopram
Participants will receive escitalopram, a selective serotonin reuptake inhibitor.

Other:
• Placebo
Participants will receive a placebo pill.

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	Burke Rehabilitation Hospital	White Plains	New York

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of depressive disorders in the study population		Measured at baseline, Week 6, and Months 3, 6, 9, 12, and 18
Secondary	Functional Independence Measure		Measured at baseline, at Week 6, and at Months 3, 6, 9, 12, and 18
Secondary	Stroke Impact Scale		Measured at baseline, Week 6, and Months 3, 6, 9, 12, and 18
Secondary	Neurocognitive tests of executive functions and speed of information processing		Measured at baseline and after 12 months