ADVERSE REACTIONS TO ASPARTAME - DOUBLE-BLIND CHALLENGE IN PATIENTS FROM A VULNERABLE POPULATION

This study was designed to ascertain whether individuals with mood dis orders are particularly vulnerable to adverse effects of aspartame. Al though the protocol required the recruitment of 40 patients with unipo lar depression and a similar number of individuals without a psychiatr ic history, the project was halted by the Institutional Review Board a fter a total of 13 individuals had completed the study because of the severity of reactions within the group of patients with a history of d epression. In a crossover design, subjects received aspartame 30 mg/kg /day or placebo for 7 days. Despite the small n, there was a significa nt difference between aspartame and placebo in number and severity of symptoms for patients with a history of depression, whereas for indivi duals without such a history there was not. We conclude that individua ls with mood disorders a'' particularly sensitive to this artificial s weetener and its use in this population should be discouraged.