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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00071643 |
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 Other: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Prevention of Post-Stroke Depression - Treatment Strategy |
Estimated Enrollment: | 201 |
Study Start Date: | September 2002 |
Estimated Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1 Problem Solving Therapy: Experimental
Participants will receive problem solving therapy.
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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.
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2. Escitalopram: Experimental
Participants will receive escitalopram.
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Drug: Escitalopram
Participants will receive escitalopram, a selective serotonin reuptake inhibitor.
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3 Placebo: Placebo Comparator
Participants will receive placebo.
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Other: Placebo
Participants will receive a placebo pill.
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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.
Ages Eligible for Study: | 31 Years to 89 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Illinois | |
University of Chicago | |
Chicago, Illinois, United States, 60637 | |
United States, Iowa | |
University of Iowa Hospitals and Clinics | |
Iowa City, Iowa, United States, 52242-1000 | |
United States, New York | |
Burke Rehabilitation Hospital | |
White Plains, New York, United States, 10605 |
Responsible Party: | University of Iowa ( Robert G. Robinson, MD ) |
Study ID Numbers: | R01 MH65134, DATR A4-GPX |
Study First Received: | October 29, 2003 |
Last Updated: | August 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00071643 |
Health Authority: | United States: Federal Government |
Stroke |
Depression Cerebral Infarction Stroke Vascular Diseases Central Nervous System Diseases Ischemia Depressive Disorder Brain Diseases Citalopram |
Cerebrovascular Disorders Serotonin Behavioral Symptoms Mental Disorders Mood Disorders Brain Ischemia Brain Infarction Dexetimide Infarction |
Parasympatholytics Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Cholinergic Antagonists Anti-Dyskinesia Agents Nervous System Diseases Physiological Effects of Drugs Psychotropic Drugs Antiparkinson Agents Cholinergic Agents |
Serotonin Uptake Inhibitors Pharmacologic Actions Muscarinic Antagonists Serotonin Agents Autonomic Agents Therapeutic Uses Cardiovascular Diseases Peripheral Nervous System Agents Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents |