1. J Clin Psychiatry. 2007 Nov;68(11):1648-54.

Vitamin B6 treatment for tardive dyskinesia: a randomized, double-blind,
placebo-controlled, crossover study.

Lerner V, Miodownik C, Kaptsan A, Bersudsky Y, Libov I, Sela BA, Witztum E.

Division of Psychiatry, Ministry of Health Be'er Sheva Mental Health Center,
Faculty of Health Sciences, Ben-Gurion University of the Negev, Be'er-Sheva,
Israel. lernervld@yahoo.com

BACKGROUND: Tardive dyskinesia (TD) is a significant clinical problem. Vitamin
B(6) is a potent antioxidant and takes part in almost all of the possible
mechanisms that are suggested as being associated with appearance of TD. The aims
of this study were (1) to reexamine the efficacy and safety of higher doses of
vitamin B(6) versus placebo in a greater sample of patients for a longer time and
(2) to evaluate the carryover effect of vitamin B(6). METHOD: A 26-week,
double-blind, placebo-controlled trial was conducted in a university-based
research clinic from August 2002 to January 2005 on 50 inpatients with DSM-IV
diagnoses of schizophrenia or schizoaffective disorder and TD. In a double-blind
crossover paradigm, all study subjects were randomly assigned to start treatment
with either vitamin B(6) (daily dose of 1200 mg) or placebo. After 12 weeks of
treatment and then a 2-week washout, subjects were crossed over to receive the
other treatment for 12 weeks. The primary outcome measure was the change from
baseline in Extra-pyramidal Symptom Rating Scale (ESRS) scores. RESULTS: The mean
decrease in ESRS clinical global impression scores from baseline to endpoint was
2.4 points in patients treated with vitamin B(6) and 0.2 points in patients
treated with placebo (p < .0001). The mean decrease in the parkinsonism subscale
score was 18.5 points and 1.4 points, respectively (p < .00001), and the mean
decrease in the dyskinesia subscale score was 5.2 points and -0.8 points,
respectively (p < .0001). CONCLUSION: Vitamin B(6) appears to be effective in
reducing symptoms of TD. The specific mechanisms by which vitamin B(6) attenuates
symptoms of TD are not clear.

PMID: 18052557 [PubMed - indexed for MEDLINE]