Biological Psychiatry
Volume 34, Issue 1 , Pages 13-17, 1 July 1993

Adverse reactions to aspartame: Double-blind challenge in patients from a vulnerable population

  • Ralph G. Walton

      Affiliations

    • Corresponding Author InformationAddress reprint requests to Ralph G. Walton, MD, Department of Psychiatry, Western Reserve Care System, 500 Gypsy Lane, Youngstown, OH 44501 USA.
    • Department of Psychiatry, Northeastern Ohio Universities College of Medicine and Department of Psychiatry, Youngstown, OH, USA
  • ,
  • Robert Hudak

      Affiliations

    • Department of Psychiatry, University Hospital of Cleveland, Cleveland, OH, USA
  • ,
  • Ruth J. Green-Waite

      Affiliations

    • Director of Research Western Reserve Care System, Youngstown, OH, USA

Received 3 October 1992; received in revised form 31 March 1993

Abstract 

This study was designed to ascertain whether individuals with mood disorders are particularly vulnerable to adverse effects of aspartame. Although the protocol required the recruitment of 40 patients with unipolar depression and a similar number of individuals without a psychiatric history, the project was halted by the Institutional Review Board after a total of 13 individuals had completed the study because of the severity of reactions within the group of patients with a history of depression.

In a crossover design, subjects received aspartame 30 mg/kg/day or placebo for 7 days. Despite the small n, there was a significant difference between aspartame and placebo in number and severity of symptoms for patients with a history of depression, whereas for individuals without such a history there was not. We conclude that individuals with mood disorders are particularly sensitive to this artificial sweetener and its use in this population should be discouraged.

Keywords:  Aspartame, depression, double-blind study, adverse reactions

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PII: 0006-3223(93)90251-8

Biological Psychiatry
Volume 34, Issue 1 , Pages 13-17, 1 July 1993