Sertraline for Preventing Post-stroke Depression and Improving Rehabilitation Outcomes

Stopped early · Phase 4 · Has a placebo group

Conditions studied: Cerebrovascular Accident, Depression

In brief

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

Key facts

Study ID

NCT00177424

Run by

University of Pittsburgh

People needed

154

Starts

2004-07-01

Expected to finish

2007-10-01

Last updated by the study team

2014-06-27

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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