Status:
TERMINATED
Sertraline for Preventing Post-stroke Depression and Improving Rehabilitation Outcomes
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Cerebrovascular Accident
Depression
Eligibility:
All Genders
40+ years
Phase:
PHASE4
Brief Summary
This study will determine the effectiveness of sertraline administration after a stroke in preventing the onset of post-stroke depression.
Detailed Description
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 wit...
Eligibility Criteria
Inclusion
- Ischemic stroke within 3 months of study entry
- Admitted to a UPMC hospital for acute inpatient treatment or rehabilitation of stroke
- Speaks English
- Females willing to use an effective form of birth control throughout the study
Exclusion
- Meets DSM-IV-TR criteria for a major depressive episode
- History of any bipolar disorder
- Psychotic or history of a psychotic disorder
- Meets DMS-IV TR criteria for alcohol or substance abuse or dependence criteria within 3 months of study entry
- Current treatment with antidepressant medication for any reason (e.g., anxiety disorder, neuropathic pain)
- Primary hemorrhagic stroke
- Language impairment severe enough to prevent valid neuropsychiatric assessment
- History of another CNS disease other than prior stroke or psychiatric illness (e.g., head trauma, multiple sclerosis, HIV with CNS involvement)
- Pulse \<50 or \>100 beats per minute
- Significant hyponatremia (Na \<130meq)
- Current hypothyroid state
- Medically unstable including symptoms of delirium (determined by review of the subject's medical status with the treating (clinical) physician; standard blood chemistry lab work will be obtained if not checked within the preceding 30 days)
- History of sensitivity to sertraline
- Pregnant or breastfeeding
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2007
Estimated Enrollment :
154 Patients enrolled
Trial Details
Trial ID
NCT00177424
Start Date
July 1 2004
End Date
October 1 2007
Last Update
June 27 2014
Active Locations (1)
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1
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213