Changes in Tardive Dyskinesia Symptoms in Elderly Patients Treated with Ganglioside GM1 or Placebo

Abstract

The unique role of ganglioside GM1 in neuronal plasticity led two centers, New York University and McLean Hospital, to study the effect of GM1 or placebo in patients with tardive dyskinesia. Results from the NYU cohort have already been published. We now present data from the entire cohort, allowing us to evaluate the effects of GM1 in the elderly compared to young adults. Subjects with tardive dyskinesia were randomly assigned to single-blind placebo injections for 1 week, followed by 1 month of double-blind intramuscular placebo or GM1100 mg. The final sample included 29 patients: 12 younger than 55 years of age and 17 older. There was no GM1-versus-placebo difference observed in either-age group, or in the total group. However, whether on placebo or GM1, repeated measures analysis of variance (RANOVA) found a significant difference in response between Abnormal Involuntary Movement Scale scores, taken baseline and week 4, in the elderly compared to young adults. Scores for the young adults show initial improvement then deterioration back to baseline, and those for the elderly show continuing improvement during the 4-week trial. The importance of the placebo effect in the elderly and its meaning for studies of GM1 in tardive dyskinesia are discussed.