| Trial ID: | L0765 |
| Source ID: | NCT02407821
|
| Associated Drug: |
Escitalopram
|
| Title: |
The Routine Use of SSRI's at the Initiation of End-stage Renal Disease Treatment (RoSIE)
|
| Acronym: |
RoSIE
|
| Status: |
TERMINATED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
End Stage Renal Disease
|
| Interventions: |
DRUG: Escitalopram|DRUG: Placebo
|
| Outcome Measures: |
Primary: 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80% of doses taken, 12 months | Secondary: Serious adverse events, 12 months|Number of patients withdrawn from the study drug due to QTc prolongation, 12 months|Completion rate for all secondary outcome measures (KDQoL, HUI-III, PHQ-9, Handgrip and 2-Minute Walk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
|
| Sponsor/Collaborators: |
Sponsor: University Health Network, Toronto | Collaborators: McMaster University|Unity Health Toronto|University of Toronto
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
25
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2015-03
|
| Completion Date: |
2017-01
|
| Results First Posted: |
|
| Last Update Posted: |
2018-10-11
|
| Locations: |
St. Joseph's Healthcare Hamilton, Hamilton, Ontario, L8N 4A6, Canada|St. Michael's Hospital, Toronto, Ontario, M5B 1W8, Canada|University Health Network, Toronto, Ontario, M6G 2K8, Canada
|
| URL: |
https://clinicaltrials.gov/show/NCT02407821
|
