Background: Several short-term, controlled trials have documented the effic
acy of vitamin E in treating tardive dyskinesia. However, the persistent na
ture of the disease prompted us to perform a multicenter, longer-term trial
of vitamin E.
Methods: The study was a prospective, randomized, 9-site trial of up to 2 y
ears of treatment with d-vitamin E (1600 IU/d) vs matching placebo. One hun
dred fifty-eight subjects with tardive dyskinesia who were receiving neurol
eptic medications were enrolled. The blinded assessments performed were cli
nical (Abnormal Involuntary Movements Scale, Barnes Akathisia Scale, and Mo
dified Simpson-Angus [for Extrapyramidal Symptoms] Scale) and electromechan
ical assessments of movement disorders, psychiatric status (Brief Psychiatr
ic Rating Scale), and functioning (Global Assessment of Functioning). There
were no significant differences in baseline demographic characteristics or
in study assessments between the group that received vitamin E and the gro
up that received placebo.
Results: Vitamin E was well tolerated and subject compliance with medicatio
n was good and similar between treatment groups. One hundred seven subjects
(70% of those receiving vitamin E and 66% of subjects receiving placebo) c
ompleted at least 1 year of treatment. There were no significant effects of
vitamin E on total scores or subscale scores for the AIMS, electromechanic
al measures of dyskinesia, or scores from the other + scales.
Conclusion: This long-term, randomized trial of vitamin E vs placebo found
no evidence for efficacy of vitamin E in the treatment of tardive dyskinesi
a.