Stockler, M. R., O’Connell, R., Nowak, A. K., Goldstein, D., Turner, J., Wilcken, N. R., Zoloft's Effects on Symptoms and survival Time Trial Group. (2007). Effect of sertraline on symptoms and survival in patients with advanced cancer, but without major depression: a placebo-controlled double-blind randomised trial. Lancet Oncology, 8, 603–612.
The sertraline intervention required patients to take 50 mg/day of the study drug or a matched placebo for the study period. Patients who developed symptoms of major depression were referred to a psychiatrist coinvestigator at the institution. If there was a definite indication for antidepressants or if patients decided to stop the study due to adverse events, the drug was discontinued gradually by reducing the dose to 25 mg/day for one week before stopping. Patient outcomes were assessed at baseline and 4, 8, 12, 16, 26, 39, and 52 weeks.
This was a multicenter trial conducted in the oncology clinics of several Australian hospitals.
Patients were undergoing the active treatment phase of care.
The study was a double-blind, placebo-controlled, centrally randomized trial that was stratified for institution, sex, anticipated future cytotoxic treatment, and Performance Score:
Sertraline had no significant effect in improving fatigue compared to placebo. Outcomes were compared on the basis of scores at baseline and four and eight weeks.