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

• Status: Terminated
• Trial end date: 2017-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Health Network, Toronto
• Collaborators: McMaster University; St. Michael's Hospital, Toronto; Unity Health Toronto; University of Toronto
• Treatments: Citalopram; Dexetimide; Serotonin Uptake Inhibitors

Criteria

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