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

NCT02407821 | Terminated Phase 2 DMC

• 1 other identifier: 01
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• Proportion of consecutive incident dialysis patients that are eligible

  12 months

• Proportion of eligible patients that will consent to randomization

  12 months

• Proportion of randomized patients that comply with their group assignment

  Compliance defined as \>80% of doses taken

  12 months

Secondary Outcomes (5)

• Serious adverse events

  12 months

• Number of patients withdrawn from the study drug due to QTc prolongation

  12 months

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

  3 months and 6 months

• Death

  12 months

• Hospital-free days

  12 months

Study Arms (2)

Escitalopram

ACTIVE COMPARATOR

Drug: Escitalopram

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Escitalopram DRUG

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.

Escitalopram

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Health Network, Toronto: lead
• McMaster University: collaborator
• Unity Health Toronto: collaborator
• University of Toronto: collaborator

Study Sites (3)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

University Health Network

Toronto, Ontario, M6G 2K8, Canada

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Renal Insufficiency; Renal Insufficiency, Chronic; Depression

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Vanita Jassal, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2015
• First Posted: April 3, 2015
• Study Start: March 1, 2015
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: October 11, 2018

Record last verified: 2018-09

Locations

CA (3)