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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: | NCT00177424 |
This study will determine the effectiveness of sertraline administration after a stroke in preventing the onset of post-stroke depression.
Condition | Intervention | Phase |
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Cerebrovascular Accident Depression |
Drug: sertraline Drug: Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Intervention to Prevent Post-Stroke Major Depression. |
Estimated Enrollment: | 154 |
Study Start Date: | July 2004 |
Study Completion Date: | October 2007 |
Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Sertraline
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Drug: sertraline
Subjects will initially be started on either sertraline 12.5mg/d or placebo and will receive this dose for 3 days. Subjects will then be increased to 25mg/d for 4 days, then 50mg/d for 7 days, then increased to 75mg/d. Seventy-five mg per day is the target dose for the remainder of the subject's participation in the study. The study medication will not be titrated past 75mg/d.
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2: Placebo Comparator
matching placebo
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Drug: Placebo
matching placebo tablets
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Persons who suffer from a stroke are at high risk for developing post-stroke major depression (PSMD), an illness that has a negative impact on post-stroke physical rehabilitation and is associated with increased morbidity and mortality. Unfortunately, early detection and successful treatment of post-stroke major depression improves, but does not normalize, stroke rehabilitation outcomes compared to stroke survivors who never developed post-stroke depression. Therefore, preventing the onset of PSMD and its associated disability is an attractive possibility. This study is a placebo controlled, 10-month double-blind trial of sertraline in the prevention of PSMD in stroke survivors, with a 2-month naturalistic continuation phase. The primary outcome will be the incidence of Major Depression post-stroke. Additional outcomes will include the severity of depressive symptoms post-stroke and the level of disability experienced by the two treatment groups. An exploratory analysis will also be conducted to elucidate participant characteristics that may be moderators of the participants' response to the preventive intervention, thereby refining the profile of disabled stroke survivors most likely to benefit from the preventive intervention.
Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Pennsylvania | |
University of Pittsburgh Medical Center | |
Pittsburgh, Pennsylvania, United States, 15213 |
Principal Investigator: | Ellen M Whyte, MD | University of Pittsburgh |
Responsible Party: | University of Pittsburgh ( Ellen Whyte, MD ) |
Study ID Numbers: | K23 MH67710, 0310068, DATR AK-TNGP1 |
Study First Received: | September 12, 2005 |
Last Updated: | October 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00177424 |
Health Authority: | United States: Federal Government |
Rehabilitation |
Depression Cerebral Infarction Stroke Vascular Diseases Central Nervous System Diseases Depressive Disorder, Major Ischemia Brain Diseases Depressive Disorder |
Cerebrovascular Disorders Serotonin Behavioral Symptoms Mental Disorders Mood Disorders Sertraline Brain Ischemia Brain Infarction Infarction |
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Nervous System Diseases Physiological Effects of Drugs Psychotropic Drugs Serotonin Uptake Inhibitors |
Pharmacologic Actions Serotonin Agents Therapeutic Uses Cardiovascular Diseases Central Nervous System Agents Antidepressive Agents |