The Routine Use of SSRI's at the Initiation of End-stage Renal Disease Treatment (RoSIE) (RoSIE)
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|ClinicalTrials.gov Identifier: NCT02407821|
Recruitment Status : Terminated (Poor enrolment)
First Posted : April 3, 2015
Last Update Posted : October 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|End Stage Renal Disease||Drug: Escitalopram Drug: Placebo||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Active Comparator: 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||
The matching placebo will be up-titrated and down-titrated at the same time intervals as the active medication.
- Proportion of consecutive incident dialysis patients that are eligible [ Time Frame: 12 months ]
- Proportion of eligible patients that will consent to randomization [ Time Frame: 12 months ]
- Proportion of randomized patients that comply with their group assignment [ Time Frame: 12 months ]Compliance defined as >80% of doses taken
- Serious adverse events [ Time Frame: 12 months ]
- Number of patients withdrawn from the study drug due to QTc prolongation [ Time Frame: 12 months ]
- 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 ]
- Death [ Time Frame: 12 months ]
- Hospital-free days [ Time Frame: 12 months ]
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 ClinicalTrials.gov identifier (NCT number): NCT02407821
|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|
|Principal Investigator:||Vanita Jassal, MD||University Health Network, Toronto|