Ersoy, M.A., Noyan, A.M., & Elbi, H. (2008). An open-label long-term naturalistic study of mirtazapine treatment for depression in cancer patients. Clinical Drug Investigation, 28, 113–120.

To evaluate the risk-benefit profile of the use of mirtazapine for the treatment of depression in patients with cancer

Patients were enrolled who presented for psychiatric evaluation and treatment of depression and met DSM-IV criteria for major depression (HAM-D-17 score > 18). Patients started a drug therapy of mirtazapine, 15 mg/day day orally; the dose was increased to 30 mg/day in the fourth week of therapy if patients were not responding and had no adverse effects. All patients continued receiving the minimum dose for 24 weeks, but the use of other medications was not controlled. Patients were assessed at the initial visit and at the end of weeks 4, 12, and 24. Adverse effects were noted during routine assessments.

• A total of 19 patients completed 24 weeks of follow-up and evaluation for treatment efficacy.
• The mean age was 55.47 (SD = 11.04; range = 22–69 years).
• 12 patients were female and 7 were male.
• Various types of cancer were represented, including breast, brain, gynecologic, liver, hematologic, and larynx/nasopharynx.
• The study states that most had advanced cancer, but stages were not reported.
• Most patients were receiving some form of cancer treatment (e.g., chemotherapy, radiation therapy, tamoxifen). Five patients were not receiving any cancer treatment during the study period.

• Unspecified but assumed to be outpatient
• Turkey

Active treatment

Open-label (no blinding) longitudinal study

• 17-item Hamilton Rating Scale for Depression (HAM-D-17)
• Clinical interview by psychiatrist
• Routine blood tests (heme panel and biochemistry) performed weekly during the first 12 weeks of therapy, then monthly

Clinical efficacy was defined as a greater than 50% reduction in HAM-D-17 scores (defined as a positive treatment response). Patients with HAM-D-17 scores of 8–18 were defined as partial responders. Patients with HAM-D-17 scores less than 8 and a period of at least two months without significant symptoms of depression met the criteria for remission. All patients obtained at least a 50% reduction in HAM-D-17 scores, which improved from baseline to one month and were maintained for the duration of the study (24 weeks) (p < 0.001). HAM-D-17 scores significantly decreased from baseline to one month (p < 0.001). The drug was well tolerated, and no one required discontinuation of therapy. Minimal adverse effects were reported, including mild to moderate hand tremor, fatigue, weight gain, and restless leg syndrome.

The study provides preliminary evidence that (open-label) the drug mirtazapine is safe, efficacious, and tolerated.

• The sample was small, containing fewer than 30 participants.
• The study was open-label, with no placebo control.
• The potential for selection bias existed.
• The findings could be confounded by the lack of control over the type of cancer therapy and the time lapse since cancer treatment.

This particular agent may have antiemetic effects, which may be desirable in this patient population, and it had a minimal side-effect profile. Future research should include a randomized, controlled trial examining mirtazapine versus selective serotonin reuptake inhibitors in this patient population.