Sertraline for Preventing Post-stroke Depression and Improving Rehabilitation Outcomes

Terminated

Phase 4 Results N/A

Trial Description

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 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

Trial Stopped: Recruitment goals could not be met.

Conditions

Interventions

  • Sertraline (Zoloft)Drug
    Intervention Desc: Subjects will initially be started on either sertraline 12.5mg/d or placebo and will receive this dose for 3 days. Subjects will then be increased to 25mg/d for 4 days, then 50mg/d for 7 days, then increased to 75mg/d. Seventy-five mg per day is the target dose for the remainder of the subject's participation in the study. The study medication will not be titrated past 75mg/d.
    ARM 1: Kind: Experimental
    Label: 1
    Description: Sertraline
  • Placebo Drug
    Intervention Desc: matching placebo tablets
    ARM 1: Kind: Experimental
    Label: 2
    Description: matching placebo

Trial Design

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

Patient Involvement

Eligible patients will be randomized to receive either sertraline or placebo once daily for 6 months. Patients in the sertraline cohort will receive sertraline 25 mg/day for the first week, and sertraline 50 mg/day for the rest of the study. Follow-up visits are scheduled at 1, 3, and 6 months. Depressive symptoms, functional outcome, and cognitive performance will be measured at all three visits. Quality of life will be assessed at 3 and 6 months.

Outcomes

Type Measure Time Frame Safety Issue
Primary The primary outcome will be the incidence of Major Depression post-stroke.
Secondary Additional outcomes will include the severity of depressive symptoms post-stroke as measured by the Hamilton Depression Rating Scale, and the level of disability experienced by the two treatment groups, as measured by the Functional Independence Measure.

Sponsors