Sertraline for Preventing Post-stroke Depression and Improving Rehabilitation Outcomes

• Status: Terminated
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will determine the effectiveness of sertraline administration after a stroke in preventing the onset of post-stroke depression.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pittsburgh
• Collaborator: National Institute of Mental Health (NIMH)
• Treatments: Sertraline

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