OBJECTIVE: To test the safety and efficacy of fluoxetine in patients with renal failure on dialysis. METHOD:Fourteen patients with major depression and endstage renal disease on hemodialysis were randomized into two groups for an eight-week study. Subjects as well as investigators were blinded as to which subject received fluoxetine and which placebo. Patients were carefully monitored concerning adverse events, serum fluoxetine and norfluoxetine levels, and psychological measurements of degree of depression. RESULTS: No patients discontinued treatment because of adverse events, all of which were minor. All psychological tests showed improvement in depression at the four-week and eight-weeks point, although statistical significance could only be demonstrated at the fourth week of this study. All patients in the active group had serum plasma concentrations of fluoxetine andnorfluoxetine less than 250 ng/ml at eight weeks, similar to levels in patients with normal renal function in a previous open label study. CONCLUSIONS: This study confirms the relative safety of fluoxetine in depressed patients in renal failure on hemodialysis. It also suggests that fluoxetine may be efficacious in depressed patients on dialysis.
RCT Entities:
OBJECTIVE: To test the safety and efficacy of fluoxetine in patients with renal failure on dialysis. METHOD: Fourteen patients with major depression and end stage renal disease on hemodialysis were randomized into two groups for an eight-week study. Subjects as well as investigators were blinded as to which subject received fluoxetine and which placebo. Patients were carefully monitored concerning adverse events, serum fluoxetine and norfluoxetine levels, and psychological measurements of degree of depression. RESULTS: No patients discontinued treatment because of adverse events, all of which were minor. All psychological tests showed improvement in depression at the four-week and eight-weeks point, although statistical significance could only be demonstrated at the fourth week of this study. All patients in the active group had serum plasma concentrations of fluoxetine and norfluoxetine less than 250 ng/ml at eight weeks, similar to levels in patients with normal renal function in a previous open label study. CONCLUSIONS: This study confirms the relative safety of fluoxetine in depressedpatients in renal failure on hemodialysis. It also suggests that fluoxetine may be efficacious in depressedpatients on dialysis.
Authors: Winfried Rief; Yvonne Nestoriuc; Anna von Lilienfeld-Toal; Imis Dogan; Franziska Schreiber; Stefan G Hofmann; Arthur J Barsky; Jerry Avorn Journal: Drug Saf Date: 2009 Impact factor: 5.606
Authors: Daniel Cukor; Nisha Ver Halen; Deborah Rosenthal Asher; Jeremy D Coplan; Jeremy Weedon; Katarzyna E Wyka; Subodh J Saggi; Paul L Kimmel Journal: J Am Soc Nephrol Date: 2013-10-10 Impact factor: 10.121
Authors: Mark L Unruh; Brett Larive; Glenn M Chertow; Paul W Eggers; Amit X Garg; Jennifer Gassman; Maria Tarallo; Fredric O Finkelstein; Paul L Kimmel Journal: Am J Kidney Dis Date: 2013-01-15 Impact factor: 8.860