Sertraline for Preventing Post-stroke Depression and Improving Rehabilitation Outcomes

Depression Clinical Trial

Official title: Intervention to Prevent Post-Stroke Major Depression.

Status Terminated

Clinical Trial Summary

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

Clinical Trial 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 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.

For information on a related study, please follow this link:

http://clinicaltrials.gov/show/NCT00781326 ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cerebrovascular Accident
• Depression
• Depressive Disorder
• Stroke

• NCT number: NCT00177424
• Study type: Interventional
• Source: University of Pittsburgh
• Status: Terminated
• Phase: Phase 4
• Start date: July 2004
• Completion date: October 2007