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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02407821
Recruitment Status : Terminated (Poor enrolment)
First Posted : April 3, 2015
Last Update Posted : October 11, 2018
McMaster University
St. Michael's Hospital, Toronto
University of Toronto
Information provided by (Responsible Party):
University Health Network, Toronto

Brief 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.

Condition or disease Intervention/treatment Phase
End Stage Renal Disease Drug: Escitalopram Drug: Placebo Phase 2

Detailed Description:

Over 120,000 people with kidney disease start chronic dialysis therapy across North America each year. In addition to high mortality, studies uniformly report high rates of depression, pain and non-specific symptoms after dialysis is started. Suicide rates are high, particularly early in the treatment history, and withdrawal from dialysis is increasingly common in recent years, suggesting a high burden of depressive symptoms. While various treatments appear to be effective, there are multiple barriers preventing patients from getting or accepting appropriate care for depression. The investigators hypothesize that antidepressant therapy may improve morbidity and mortality when prescribed to patients with acute or chronic kidney disease (CKD) around the time of starting chronic dialysis therapy.

This is a phase II, multi-centre, double blind, randomized controlled trial to compare the safety and feasibility of oral escitalopram to placebo in incident dialysis patients. Those who have started chronic dialysis therapy within 12 weeks of being identified will be eligible for the study. Participants will randomized 1:1 to receive either escitalopram or placebo daily for 26 weeks.

The primary outcome is feasibility in terms of recruitment rates and protocol compliance. The secondary outcomes include estimates of safety (adverse events) and efficacy (hospitalization days, mortality, and changes in depression and quality of life scores). This pilot trial is intended to guide and inform the design of a full scale study to evaluate whether the routine use of escitalopram can improve the quality of life and hospital free days in patients on dialysis, as compared to placebo.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Pilot Study to Evaluate the Feasibility and Safety of Performing a Double Blind, Placebo-controlled, Randomized Controlled Trial of the Routine Use of SSRI's at the Initiation of End-stage Renal Disease Treatment
Study Start Date : March 2015
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Escitalopram 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.

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

Primary Outcome Measures :
  1. Proportion of consecutive incident dialysis patients that are eligible [ Time Frame: 12 months ]
  2. Proportion of eligible patients that will consent to randomization [ Time Frame: 12 months ]
  3. Proportion of randomized patients that comply with their group assignment [ Time Frame: 12 months ]
    Compliance defined as >80% of doses taken

Secondary Outcome Measures :
  1. Serious adverse events [ Time Frame: 12 months ]
  2. Number of patients withdrawn from the study drug due to QTc prolongation [ Time Frame: 12 months ]
  3. Completion rate for all secondary outcome measures (KDQoL, HUI-III, PHQ-9, Handgrip and 2-Minute Walk Test) [ Time Frame: 3 months and 6 months ]
  4. Death [ Time Frame: 12 months ]
  5. Hospital-free days [ Time Frame: 12 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Male or Female aged ≥ 25 years
  2. Patient or substitute decision maker willing and able to give informed consent
  3. Incident to dialysis defined as within a 12-week window from the first dialysis treatment (1 week prior to, to 11 weeks after). Patients on all forms of dialysis except CRRT (including peritoneal dialysis, home hemodialysis, in-centre intermittent hemodialysis and nocturnal dialysis) will be eligible. Patients returning to dialysis after transplant graft loss will be eligible.

Exclusion Criteria:

  1. Past history of allergy to, or intolerance of, escitalopram
  2. Known severe hepatic dysfunction
  3. Recent history of active bleeding within the past 3 months (e.g. gastrointestinal bleeding requiring hospitalization) or known bleeding disorder
  4. Current use of class I anti-arrhythmic medications; SSRI or SNRI antidepressants; pimozide, MAO inhibitors, reserpine, guanethidine, cimetidine or methyldopa, omeprazole; tri-cyclic and tetra-cyclic anti-depressants, neuroleptics or anti-convulsants, triptans, tramadol, linezolid, tryptophan, and St. John's Wort; but not gabapentin
  5. Past treatment failure for depression with escitalopram or with ≥ 2 antidepressant treatments of at least 6 weeks duration each
  6. Initiation of psychotherapy for depression in the 3 months prior to study entry
  7. Alcohol or substance abuse or dependence that requires acute detoxification at study entry
  8. Present or past psychosis or bipolar disorder, schizophrenia or any other psychotic disorder documented in medical records
  9. Suicidal ideation defined as the patient is at significant risk of suicide on the Columbia Suicide Scale71 or has attempted suicide within 6 months prior to the Screening Visit
  10. Clinically-identified major depressive disorder that, in the opinion of the clinical team, requires treatment
  11. Pregnancy, lactation and women of childbearing potential not using adequate contraception
  12. Abnormal QTc at baseline: QTcF interval >600 ms (based on the Fredericia correction where QTcF = QT/RR0.33)66
  13. Lactose intolerance (as placebo contains lactose)
  14. Known uncontrolled glaucoma
  15. Patients requiring treatment with continuous renal replacement therapy (CRRT)
  16. Documented history of brain tumour

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02407821

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Canada, Ontario
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada, L8N 4A6
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
University Health Network
Toronto, Ontario, Canada, M6G 2K8
Sponsors and Collaborators
University Health Network, Toronto
McMaster University
St. Michael's Hospital, Toronto
University of Toronto
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Principal Investigator: Vanita Jassal, MD University Health Network, Toronto
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Responsible Party: University Health Network, Toronto Identifier: NCT02407821    
Other Study ID Numbers: 01
First Posted: April 3, 2015    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: September 2018
Keywords provided by University Health Network, Toronto:
Controlled Clinical Trials, Randomized
Kidney Failure
Renal Insufficiency, Chronic
Dialysis, Renal
Peritoneal Dialysis
Depressive Symptoms
Selective Serotonin Reuptake Inhibitors
Additional relevant MeSH terms:
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Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs