Directly Observed Weekly Fluoxetine for Major Depressive Disorder Among Hemodialysis Patients: A Single-Arm Feasibility Trial

RATIONALE & OBJECTIVE: Major depressive disorder (MDD) is common among hemodialysis patients, but treatment can add to their pill burden and may be limited by nonadherence. We sought to investigate the value of directly observed, once-weekly fluoxetine dosing in MDD. STUDY DESIGN: Feasibility trial of adult hemodialysis patients with untreated MDD. The diagnosis of MDD was determined using the Mini International Neuropsychiatric Interview. SETTING & PARTICIPANTS: 16 patients at 15 hemodialysis facilities in Northeast Ohio. INTERVENTION: Patients were initially prescribed 20 mg of fluoxetine once daily for 2 weeks to assess their tolerance. The patients took this daily fluoxetine unobserved at home. They were then transitioned to 90 mg of fluoxetine once weekly for 10 weeks. The patients took this weekly fluoxetine during hemodialysis treatment and were observed by the study staff. The dose was increased to 180 mg once weekly among patients with an inadequate response based on the judgment of the prescribing clinician. OUTCOMES: Mini International Neuropsychiatric Interview diagnosis of MDD at the end of the trial and changes in the Patient Health Questionnaire (PHQ-9) scores over 12 weeks. RESULTS: One patient withdrew from active treatment after 2 daily doses of 20 mg of fluoxetine because of side effects of stomach cramping, vomiting, dizziness, and lightheadedness but completed the baseline and final assessments. The remaining 15 patients received all scheduled weekly fluoxetine doses during the trial. At 12 weeks, 14 of 16 patients (87.5%) no longer met the criteria for MDD (P < 0.001). Among all participants, the mean PHQ-9 scores decreased from 11.3 to 6.6 (P = 0.002). LIMITATIONS: Small sample size, modestly elevated baseline PHQ-9 scores, no comparison group, and short treatment duration. CONCLUSIONS: Directly observed, once-weekly fluoxetine may be an effective and well-tolerated treatment option for hemodialysis patients. Future research should investigate longer-term health outcomes of weekly fluoxetine in this population and explore the feasibility of implementing this depression treatment model in routine clinical practice. TRIAL REGISTRATION: This trial was registered at clinicaltrials.gov as NCT03390933.