P100: Dual Role of Mirtazapine in Managing Depression & Nause in Cancer Patients on Chemotherapy: A prospective Observational Study
Poster Presenter
Meghana Karnaty
masters in regulatory affairs
Northeastern University United States
Objectives
To evaluate the efficacy, safety, and tolerability of mirtazapine in managing cancer-related depression and chemotherapy-induced nausea and vomiting, while also assessing its impact on appetite, sleep disturbances, and overall quality of life in patients undergoing chemotherapy.
Method
A prospective observational study was conducted at AIG Hospitals, Hyderabad, from December 2022 to May 2023 among 27 cancer patients receiving chemotherapy and mirtazapine. Depression and nausea were assessed using MADRS and CGI scales, with outcomes analyzed using paired t-tests.
Results
A total of 27 patients were enrolled in the study, and 25 completed the treatment and were included in the final analysis. The mean age of participants was 54.2 years, with 52% females and 48% males. Patients had various cancer diagnoses, with periampullary carcinoma being the most common (20%).
A statistically significant reduction in depressive symptoms was observed after mirtazapine treatment. The mean total MADRS score decreased from 26.9 at baseline to 7.7 post-treatment (p < 0.001), reflecting a shift from moderate depression to mild or normal range in most patients. Significant improvements were also seen across individual MADRS domains, including sadness, inner tension, concentration, appetite, sleep, and pessimistic thoughts.
Appetite improved in 23 of 25 patients, with mean appetite scores significantly reduced following treatment (p < 0.001). Sleep quality improved in 22 patients, demonstrating statistically significant changes in sleep-related scores (p < 0.001).
Chemotherapy-induced nausea and vomiting, assessed using the Clinical Global Impression (CGI) scale, showed a significant reduction in severity after mirtazapine administration (p < 0.001), indicating meaningful antiemetic benefit.
Regarding safety, 76% of patients reported no adverse effects. Mild sedation was the most common side effect (16%), while one patient (4%) experienced tremors. No clinically significant hepatic or renal function abnormalities were observed. Overall, 92% of participants tolerated the medication well.
These findings confirm the study hypothesis that mirtazapine significantly improves both psychological and gastrointestinal symptoms in cancer patients undergoing chemotherapy while maintaining a favorable safety profile.
Conclusion
This study demonstrates that mirtazapine is an effective and well-tolerated therapeutic option for cancer patients undergoing chemotherapy who experience coexisting depression and chemotherapy-induced nausea and vomiting. Significant improvements were observed in depressive symptoms, appetite, sleep quality, and gastrointestinal discomfort, supporting its dual mechanism of action as both an antidepressant and 5-HT3 receptor antagonist. The reduction in MADRS and CGI scores confirms clinically meaningful benefits in both psychological and physical symptom domains.
Importantly, the majority of patients tolerated mirtazapine well, with minimal and manageable adverse effects, primarily mild sedation. No significant hepatic or renal safety concerns were identified. The ability of mirtazapine to target multiple distressing symptoms simultaneously suggests a potential reduction in polypharmacy, improved treatment adherence, and enhanced overall quality of life in this vulnerable population.
Although the study was limited by its single-center design, small sample size, and lack of a control group, the findings provide promising preliminary evidence supporting the role of mirtazapine as adjunct supportive therapy in oncology care. Larger randomized controlled trials with longer follow-up are warranted to confirm these findings and establish optimal dosing strategies. Overall, mirtazapine represents a practical and clinically meaningful option for comprehensive symptom management in cancer patients receiving chemotherapy.
