Kim, S. W., Shin, I. S., Kim, J. M., Kim, Y. C., Kim, K. S., Kim, K. M., . . . Yoon, J. S. (2008).  Effectiveness of mirtazapine for nausea and insomnia in cancer patients with depression. Psychiatry and Clinical Neurosciences, 62, 75–83.

To study the effectiveness of mirtazapine on various cancer-related symptoms, such as nausea, sleep disturbance, pain, and depression.

Patients were treated at a starting dosage of 15 mg of mirtazapine in orally disintegrating tablets a day. The dosage was titrated between 15 and 45 mg per day based on clinical judgment. Mean treatment dosage was 19.6 mg per day in the total population and 22.9 mg in those who completed the study. Patients were administered serial assessments at baseline and on days 1, 3, 5, 7, 14, and 28.

• The sample was comprised of 42 patients (55% males, 45% females).
• Mean age was 57.5 years (standard deviation = 12 years; range 22–79 years).
• Patients had mixed cancers, 59% of which were lung, breast, gastrointestinal, hepatobiliary tract, or other. Of the patients, 61% had stage IV cancer.
• Patients had malignant cancer AND nausea or insomnia.

• Single site
• Inpatient (88%)
• Korea

The study used a prospective, open-label, repeated measure design.

• Clinical Global Impression (CGI) scale for nausea/vomiting 
• Chonnam National University Hospital–Leeds Sleep Evaluation Questionnaire (C-LSEQ)
• Montgomery–Åsberg Depression Rating Scale (MADRS) (two items):  reduced sleep and reduced appetite 
• MÅDRS total score:  10-item objective rating scale to assess depression
• Short Form Health Survey 36 (SF-36) (two bodily pain items)
• EuroQOL (EQ)-5D
• Udvalg for KliniskeUndersogelser (UKU) scale for sleepiness/sedation and dizziness

Nausea improved significantly from day 1 after administration of mirtazapine (p < 0.001). Improvement was sustained throughout the treatment and seemed to work best for patients actively receiving chemotherapy. In addition, anorexia improved. All sleep measures improved, many as early as day 1, but at least one measure (ease of wakening) did not improve until day 5 (p < 0.001). Mirtazapine increased sleepiness in one of three patients, but this resolved after several days on therapy. Reduction in pain scores (p < 0.5), improvement in depression score (p < 0.01), and overall quality of life (QOL) (p < 0.01) were noted as well.

Mirtazapine may be helpful in treating the cancer-related symptoms of nausea, sleep disturbance, anorexia, pain, and depression, as well as improving QOL.

• The study had a small sample size, with less than 100 patients.
• The mirtazapine dosage varied.
• The study had a high drop-out rate.
• The patients were a heterogeneous group as far as concomitant medications were concerned. These were not controlled for, and patients were allowed to continue preexisting medications for nausea, hypnotics, and analgesics.
• The percentage of inpatients was high.

Mirtazapine may be useful in treating chemotherapy-related symptoms, especially sleep disturbance and nausea, in patients with malignant cancers.