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Sertraline for Preventing Post-stroke Depression and Improving Rehabilitation Outcomes

NCT00177424 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 154

Last updated 2014-06-27

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

sertraline

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.

DRUG

Placebo

matching placebo tablets

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • University of Pittsburgh

    lead OTHER

Principal Investigators

  • Ellen M Whyte, MD · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-07-31
Primary Completion
2007-10-31
Completion
2007-10-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00177424 on ClinicalTrials.gov