Musselman, D.L., Lawson, D.H., Gumnick, J.F., Manatunga, A.K., Penna, S., Goodkin, R.S., . . . Miller, A.H. (2001). Paroxetine for the prevention of depression induced by high-dose interferon alfa. New England Journal of Medicine, 344, 961–966.

Patients with malignant melanoma received paroxetine or a placebo two weeks prior to initiation of interferon alfa, continuing for the first 12 weeks of therapy. Study tablets contained 10 mg paroxetine; both groups took one tablet daily for a week, followed by 2 tablets daily for a week. Two weeks after the initiation of interferon alfa (four weeks after beginning paroxetine or placebo), the dosage of the study medication could be increased up to four tablets per day at the discretion of the study psychiatrist. The average number of tablets at the maximal dose for each group was 3.1. Patients were evaluated at baseline and at regularly scheduled intervals for the first 12 weeks of therapy.

40 adult patients with malignant melanoma that had been resected but was estimated to have a greater than 50% chance of recurrence

Single site

Randomized, double-blind study

• Hamilton Rating Scale for Depression
• Carroll Rating Scale for Depression
• Hamilton Rating Scale for Anxiety
• Neurotoxicity Scale

• Major depression symptoms developed in 2 of 18 patients (11%) in the paroxetine group  and 9 of 20 (45%) in the placebo group.
• Paroxetine treatment significantly decreased the likelihood that interferon alfa therapy would have to be discontinued because of severe depression.

The sample size was small. One disease group and one site were involved in the study.