CHAPEL HILL, N.C. - It’s no surprise that a cancer diagnosis can cause depression or make existing depression worse. But, despite numerous national and international trials of anti-depressant medicines in medically healthy patients, physicians do not know for sure which, if any, medications work for cancer patients with depression. A pilot clinical trial at UNC will test two standard antidepressants to determine whether or not the drugs can alleviate symptoms in these patients.
“To date, evidence of efficacy for antidepressant drugs has been modest,” says Ryan Raddin, MD, hematology oncology fellow, and principal investigator of the trial. “In this pilot study, we will explore whether the medications, citalopram and mirtazapine, are efficacious in cancer patients. Additionally, our unique study design will seek to mirror clinical practice by tailoring the medication to individual symptoms.”
“Studying depression in patients with cancer is particularly important,” explains Donald Rosenstein, MD, trial co-principal investigator, professor of psychiatry and director of the UNC Lineberger Comprehensive Cancer Support Program. “Some studies have shown that as many as 40 percent of cancer patients have major depressive disorder. Depression can be detected by a symptom inventory or screening tests. Poorly controlled depression affects both quality of life and adherence to cancer treatment.”
Study scientists will recruit 52 cancer patients being treated at UNC for the nine-week trial. All study participants will receive standard psychosocial support and will receive mirtazapine, citalopram or placebo, based on their presenting symptom profile and random assignment. The study is a double-blind trial, meaning that neither the patients nor the trial leaders will know to which arm of the study a patient has been assigned until the conclusion of the trial.
“This is the first investigator-initiated interventional trial of the Supportive Care Program at UNC,” says, Stephen Bernard, MD, professor of medicine, co-director of the UNC Palliative Care Program and the physician in charge of the UNC Supportive Care Consultation Service and Clinic. “An interdisciplinary team of experts from oncology, supportive care, pharmacy, psychiatry, nursing and biostatistics is conducting the trial. “
Funding for this pilot study is provided in part by a grant from the University Cancer Research Fund. “If this pilot study proves efficacy for these drugs, we hope to develop a larger study involving more patients and more institutions,” says Raddin.
For more information about this trial, email the research coordinator or call 919- 966-2044.