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The Routine Use of SSRI's at the Initiation of End-stage Renal Disease Treatment (RoSIE)

NCT02407821 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2018-10-11

No results posted yet for this study

Summary

In this study the investigators hypothesize that antidepressant therapy may improve the overall welling of patients with acute or chronic kidney disease when given around the time of starting chronic dialysis therapy. This study is a pilot, randomized controlled trial that aims to examine whether prescribing oral escitalopram to all incident dialysis patients is safe and feasible.

Conditions

Interventions

DRUG

Escitalopram

Dose will be initiated at 5 mg daily. At two weeks, a safety and tolerability assessment will be performed, and if tolerated, the dose will be increased to 10 mg daily. At 24 weeks, the medication will be titrated downwards to 5 mg daily for a further two weeks before discontinuation.

DRUG

Placebo

The matching placebo will be up-titrated and down-titrated at the same time intervals as the active medication.

Sponsors & Collaborators

  • McMaster University

    collaborator OTHER

  • Unity Health Toronto

    collaborator OTHER

  • University of Toronto

    collaborator OTHER

  • University Health Network, Toronto

    lead OTHER

Principal Investigators

  • Vanita Jassal, MD · University Health Network, Toronto

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2017-01-31
Completion
2017-01-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT02407821 on ClinicalTrials.gov