Torta, R., Leombruni, P., Borio, R., & Castelli, L. (2011). Duloxetine for the treatment of mood disorder in cancer patients: A 12-week case-control clinical trial. Human Psychopharmacology, 26, 291–299.

To investigate the efficacy and tolerability of duloxetine in patients with cancer with mood disorder

Consecutive patients with diagnosed mood disorder started a regimen of duloxetine. They received an initial dose of 30 mg/day for one week, then 60 mg daily. If response was poor after one month, the dose was increased to 120 mg. Benzodiazepines were allowed as needed during the first two weeks. Study assessments were done at baseline, week 4, and week 12. Analysis compared results pertaining to those who had cancer and to those who did not.

• The study reported on a sample of 37 patients, 23 with cancer.
• Mean patient age was 63.6 years (SD = 10.9 years).
• The sample was 44.7% male and 45.3% female.
• Cancer types were not reported.

• Single site
• Outpatient setting
• Italy

Prospective observational design

• Hospital Anxiety and Depression Scale (HADS)
• State-Trait Anxiety Inventory
• EORTC questionnaire

Overall, 20% of patients dropped out of the study. Of the patients with cancer, 15% dropped out due to agitation, insomnia, or tachycardia. Analysis showed similar response over time of those with and without cancer diagnoses. Depression and anxiety by all measures declined at all follow-up times (p < 0.001).

Duloxetine was effective in reducing anxiety and depression in patients with and without cancer. The majority of patients tolerated the medication well.

• The study had small sample sizes, with samples of fewer than 30 and fewer than 100, respectively.
• The study had risks of bias due to no control group, no blinding, and no random assignment.
• Participant withdrawals were ≥ 10%.

Findings suggest that antidepressant use by patients with cancer who also have clinically relevant mood disorders can improve symptoms of anxiety and depression. Note: Most antidepressant studies that show a positive impact involve use by patients who have clinically relevant mood disorders at baseline.