Sertraline shows no clear benefits in treating depressive symptoms in CKD
In patients with chronic kidney disease (CKD) and major depressive disorder (MDD), sertraline does not appear to be significantly better than placebo in treating depressive symptoms, a recent study suggests.
“To our knowledge, this is the largest randomized, double-blind, placebo-controlled trial to provide evidence about MDD treatment with a commonly used [selective serotonin reuptake inhibitor (SSRI)] in patients with nondialysis-dependent CKD,” said the researchers.
“These results provide evidence regarding the lack of efficacy of sertraline among patients with nondialysis-dependent CKD that would change clinical practice,” they added.
In the trial, 193 nondialysis dependent patients with stage 3, 4 or 5 CKD were randomized 1:1 to receive either 50 mg/d of sertraline (n=97; mean age 57.7±14.5 years; 76.3 percent male) or matching placebo (n=96; mean age 59.1±12.2 years; 69.8 percent male).
During follow-up visits, conducted every 2 weeks for the first 6 weeks, then every 3 weeks for the remaining 6 weeks, dose was escalated depending on tolerability and patients were observed for the primary study endpoint of improvements in depressive symptom severity scores.
At baseline, depressive symptoms severity was similar between the sertraline and placebo groups, with mean scores of 14.0±2.4 and 14.1±2.4, respectively. After 12 weeks, at study exit, the respective mean changes in scores were -4.1 and -4.2, corresponding to no significant difference in treatment efficacy (mean difference [MD], 0.1; 95 percent CI, -1.1 to 1.3; p=0.82). [JAMA 2017;doi:10.1001/jama.2017.17131]
Sertraline was also not significantly more effective in improving the depressive symptoms of the stage 3 (MD, 0.7; -1.2 to 2.6; p=0.47), 4 (MD, -0.5; -2.3 to 1.2; p=0.54) and 5 (MD, 0.1; -3.0 to 3.1; p=0.97) CKD patient subgroups.
According to researchers, “depression comorbid with chronic disease is a different clinical entity than psychiatric MDD among those without comorbidity and depression that is not responsive to SSRI medications.”
There were also no improvements in secondary outcomes. Rate of remission in the total cohort, for example, did not significantly vary between treatment groups, with 15.5 and 14.6 percent of the sertraline and placebo patients achieving remission (MD, 0.9; -9.2 to 11.0; p=0.86), respectively.
Quality of life likewise did not significantly differ between groups, with the mean change in patient-reported overall health being 0 in both sertraline and placebo groups (MD, 0; -10.0 to 0; p=0.61). Notably, sertraline patients reported having significantly better sleep than the placebo patients (MD, 5.0; 0 to 12.5; p=0.03).
Overall, researchers said that sertraline was comparable to placebo in terms of alleviating depressive symptoms in CKD patients with MDD. Moreover, “[a]lthough the risk of serious adverse events was not higher in patients receiving sertraline vs placebo, those treated with sertraline did experience a significantly higher incidence of gastrointestinal adverse effects.”
Thus, “[t]hese findings do not support the use of sertraline to treat MDD in patients with nondialysis-dependent CKD,” they added.