CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 201 enrolled
Drug / intervention
Sertraline +1 moredrug
Likely dose
Sertraline 50 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00946998
NCT00946998Phase 3Completed

Randomized Trial of Sertraline Treatment of Depression in Chronic Kidney Disease

VA Office of Research and Development·interventional·Posted Jul 27, 2009·Updated Mar 9, 2018

In Brief

A Phase 3 clinical trial evaluating Sertraline and placebo for Chronic Kidney Disease and Depression. Completed, enrolled 201 participants across 2 sites.

Detailed Summary

This is a randomized double-blinded placebo-controlled trial to see if treatment with sertraline as compared with placebo tablets will improve depression symptoms in patients with chronic kidney disease who have not yet started dialysis or received a kidney transplant. The investigators will also investigate whether sertraline treatment will improve quality of life and whether it is safe to use in patients with kidney disease. The study subject will be randomly assigned to take either sertraline or a placebo tablet for 12 weeks.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 27, 2009
Enrollment StartFeb 8, 2010
Primary CompletionNov 23, 2016
Study CompletionNov 1, 2017
TodayJul 2, 2026
Enrollment to primary: 6.8 yearsPosted 16.9 years ago

Interventions

Sertralinedrug

Sertraline is a serotonin-selective reuptake inhibitor (SSRI) used to treat major depression. Dosage will begin at 50 mg/d and will be escalated by 50 mg increments every 2 weeks to a maximum of 200 mg/d

placebodrug

Placebo tablet will be identical and matched to sertraline tablet.