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| Sponsored by: |
National Institute of Mental Health (NIMH) |
| Information provided by: | National Institute of Mental Health (NIMH) |
| ClinicalTrials.gov Identifier: | NCT00071643 |
Purpose
This study will evaluate the effectiveness of both drug and non-drug treatments in preventing depression after a stroke.
| Condition | Intervention | Phase |
|
Depression Cerebrovascular Accident |
Behavioral: Problem Solving Therapy Drug: Escitalopram |
Phase III |
| Genetics Home Reference related topics: | Stroke |
| MedlinePlus related topics: | Depression |
| ChemIDplus related topics: | Escitalopram Benzetimide Citalopram Citalopram hydrobromide Dexetimide Escitalopram oxalate |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Prevention of Post-Stroke Depression - Treatment Strategy |
| Estimated Enrollment: | 201 |
| Study Start Date: | September 2002 |
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.
Eligibility
| Ages Eligible for Study: | 31 Years to 89 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Illinois | |||||
| University of Chicago | Active, not recruiting | ||||
| Chicago, Illinois, United States, 60637 | |||||
| United States, Iowa | |||||
| University of Iowa Hospitals and Clinics | Recruiting | ||||
| Iowa City, Iowa, United States, 52242-1000 | |||||
| Contact: Stephanie Rosazza, RAIII 319-353-5807 stephanie-rosazza@uiowa.edu | |||||
| Principal Investigator: Robert G. Robinson, MD | |||||
| Sub-Investigator: Ricardo E. Jorge, MD | |||||
| United States, New York | |||||
| Burke Rehabilitation Hospital | Active, not recruiting | ||||
| White Plains, New York, United States, 10605 | |||||
More Information
| Study ID Numbers: | R01 MH65134, DATR A4-GPX |
| First Received: | October 29, 2003 |
| Last Updated: | February 6, 2007 |
| ClinicalTrials.gov Identifier: | NCT00071643 |
| Health Authority: | United States: Federal Government |
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