Cankurtaran, E. S., Ozalp, E., Soygur, H., Akbiyik, D. I., Turhan, L., & Alkis, N. (2008). Mirtazapine improves sleep and lowers anxiety and depression in cancer patients: superiority over imipramine. Supportive Care in Cancer, 16, 1291–1298.

To compare the effectiveness of two psychotropic medications, mirtazapine and imipramine, on distressing somatic symptoms (i.e., pain, nausea, vomiting, decreased appetite, and sleep disturbance) of cancer as well as symptoms of depression and anxiety.

Patients self-selected to receive psychotropic medication and supportive psychotherapy (intervention group) or supportive psychotherapy only. Those who elected to take medication were randomly enrolled to receive mirtazapine or imipramine. Mean dosage of mirtazapine ranged from 5 to 30 mg/day, depending on the visit. Mean dosage of imipramine ranged from 5 to 100 mg/day, depending on the visit. Each group was then assessed at three visits:  baseline and three and six weeks after therapy had begun.

• The sample was comprised of 53 patients with cancer (35%–38.5% male, 61.5%–65% female).
• Median age was 43 to 47.5 years (range 26–56).
• All cancer types were included; no information about cancer stage was provided. 
• In each group, median time since diagnosis ranged from 6.5 to 8 months.
• All patients had an additional psychiatric diagnosis. All had cancer; were undergoing chemotherapy; and had been diagnosed with major depressive disorder, adjustment disorder, and/or anxiety disorder.

• Single site
• Outpatient
• Large oncology research and training hospital in Turkey

Patients were undergoing the active treatment phase of care.

The study used a prospective, repeated measures design.

• Patient sociodemographic information    
• Pain, nausea, and vomiting (evaluated by single-symptom scale)
• Weight
• Appetite (evaluated by single item)
• Hamilton Rating Scale for Depression (HRSD) (three items to assess sleep disturbance)
• Hospital Anxiety and Depression Scale (HADS), Turkish version

• Among the three visits, no significant differences were observed with regard to the degree of pain, nausea, vomiting, or appetite in the mirtazapine, imipramine, and control groups, and nor did differences exist in terms of the scores relating to the degree of pain, nausea, vomiting, appetite, weight, or insomnia, among the mirtazapine, imipramine, and control groups.
• In the mirtazapine group, the initial, middle, and late insomnia scores improved between the first and second and first and third visits. In the control and imipramine groups, no significant change occurred in insomnia scores between visits.
• In the imipramine group, a significant difference was seen in weight at the three visits. Median weight decreased from the second to third visit.
• In the mirtazapine group, statistically significant differences were noted in the mean total, anxiety, and depression HADS scores at each visit. Especially notable were score changes between the first and second visit. In the imipramine and control groups, no differences were found in the total, anxiety, and depression HADS scores across visits. 

Mirtazapine is effective in resolving insomnia and in reducing the symptoms of anxiety and depression in patients with cancer who have depression, anxiety, or adjustment disorders.

• The study had a small, heterogeneous sample, with less than 100 patients.
• The study had a high drop-out rate; by six weeks, 10 of 20 patients had dropped out of the control group, 4 of 20 had dropped out of the mirtazapine group, and 4 of 13 had dropped out of the imipramine group.
• The study had no control group or random assignment and presented no information about confounding factors. 
• Patients were not controlled for use of concomitant medications to treat the somatic symptoms being evaluated.

Mirtazapine may be useful in treating anxiety, depression, and insomnia in patients undergoing chemotherapy for cancer who have clinically relevant anxiety or depression. More systematic research, such as placebo-controlled studies, is required.