Sertraline for Preventing Post-stroke Depression and Improving Rehabilitation Outcomes


Phase 4 Results N/A

Eligibility Criteria

Inclusion Criteria

- 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 Criteria

- 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