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

Primary Purpose

End Stage Renal Disease

Status

Terminated

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

Escitalopram

Placebo

About this trial

This is an interventional treatment trial for End Stage Renal Disease focused on measuring Controlled Clinical Trials, Randomized, Kidney Failure, Renal Insufficiency, Chronic, Dialysis, Renal, Peritoneal Dialysis, Hemodialysis, Depressive Symptoms, Selective Serotonin Reuptake Inhibitors, Antidepressants, Escitalopram

Eligibility Criteria

25 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or Female aged ≥ 25 years
Patient or substitute decision maker willing and able to give informed consent
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:

Past history of allergy to, or intolerance of, escitalopram
Known severe hepatic dysfunction
Recent history of active bleeding within the past 3 months (e.g. gastrointestinal bleeding requiring hospitalization) or known bleeding disorder
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
Past treatment failure for depression with escitalopram or with ≥ 2 antidepressant treatments of at least 6 weeks duration each
Initiation of psychotherapy for depression in the 3 months prior to study entry
Alcohol or substance abuse or dependence that requires acute detoxification at study entry
Present or past psychosis or bipolar disorder, schizophrenia or any other psychotic disorder documented in medical records
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
Clinically-identified major depressive disorder that, in the opinion of the clinical team, requires treatment
Pregnancy, lactation and women of childbearing potential not using adequate contraception
Abnormal QTc at baseline: QTcF interval >600 ms (based on the Fredericia correction where QTcF = QT/RR0.33)66
Lactose intolerance (as placebo contains lactose)
Known uncontrolled glaucoma
Patients requiring treatment with continuous renal replacement therapy (CRRT)
Documented history of brain tumour

Sites / Locations

St. Joseph's Healthcare Hamilton
St. Michael's Hospital
University Health Network

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Escitalopram

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Proportion of consecutive incident dialysis patients that are eligible

Proportion of eligible patients that will consent to randomization

Proportion of randomized patients that comply with their group assignment

Compliance defined as >80% of doses taken

Secondary Outcome Measures

Serious adverse events

Number of patients withdrawn from the study drug due to QTc prolongation

Completion rate for all secondary outcome measures (KDQoL, HUI-III, PHQ-9, Handgrip and 2-Minute Walk Test)

Death

Hospital-free days

Full Information

NCT ID

NCT02407821

First Posted

March 16, 2015

Last Updated

October 9, 2018

Sponsor

University Health Network, Toronto

Collaborators

McMaster University, Unity Health Toronto, University of Toronto

1. Study Identification

Unique Protocol Identification Number

NCT02407821

Brief Title

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

Acronym

RoSIE

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 Type

Interventional

2. Study Status

Record Verification Date

September 2018

Overall Recruitment Status

Terminated

Why Stopped

Poor enrolment

Study Start Date

March 2015 (undefined)

Primary Completion Date

January 2017 (Actual)

Study Completion Date

January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Health Network, Toronto

Collaborators

McMaster University, Unity Health Toronto, University of Toronto

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

End Stage Renal Disease

Keywords

Controlled Clinical Trials, Randomized, Kidney Failure, Renal Insufficiency, Chronic, Dialysis, Renal, Peritoneal Dialysis, Hemodialysis, Depressive Symptoms, Selective Serotonin Reuptake Inhibitors, Antidepressants, Escitalopram

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Escitalopram

Arm Type

Active Comparator

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Escitalopram

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Proportion of consecutive incident dialysis patients that are eligible

Time Frame

12 months

Title

Proportion of eligible patients that will consent to randomization

Time Frame

12 months

Title

Proportion of randomized patients that comply with their group assignment

Description

Compliance defined as >80% of doses taken

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Serious adverse events

Time Frame

12 months

Title

Number of patients withdrawn from the study drug due to QTc prolongation

Time Frame

12 months

Title

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

Title

Death

Time Frame

12 months

Title

Hospital-free days

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or Female aged ≥ 25 years Patient or substitute decision maker willing and able to give informed consent 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: Past history of allergy to, or intolerance of, escitalopram Known severe hepatic dysfunction Recent history of active bleeding within the past 3 months (e.g. gastrointestinal bleeding requiring hospitalization) or known bleeding disorder 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 Past treatment failure for depression with escitalopram or with ≥ 2 antidepressant treatments of at least 6 weeks duration each Initiation of psychotherapy for depression in the 3 months prior to study entry Alcohol or substance abuse or dependence that requires acute detoxification at study entry Present or past psychosis or bipolar disorder, schizophrenia or any other psychotic disorder documented in medical records 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 Clinically-identified major depressive disorder that, in the opinion of the clinical team, requires treatment Pregnancy, lactation and women of childbearing potential not using adequate contraception Abnormal QTc at baseline: QTcF interval >600 ms (based on the Fredericia correction where QTcF = QT/RR0.33)66 Lactose intolerance (as placebo contains lactose) Known uncontrolled glaucoma Patients requiring treatment with continuous renal replacement therapy (CRRT) Documented history of brain tumour

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Vanita Jassal, MD

Organizational Affiliation

University Health Network, Toronto

Official's Role

Principal Investigator

Facility Information:

Facility Name

St. Joseph's Healthcare Hamilton

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8N 4A6

Country

Canada

Facility Name

St. Michael's Hospital

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5B 1W8

Country

Canada

Facility Name

University Health Network

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M6G 2K8

Country

Canada

12. IPD Sharing Statement

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

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