Vitamin B₆ Treatment for Tardive Dyskinesia: A Randomized, Double-Blind, Placebo-Controlled, Crossover Study

Vladimir Lerner, M.D., Ph.D.; Chanoch Miodownik, M.D.; Alexander Kaptsan, M.D.; Yuly Bersudsky, M.D., Ph.D.; Igor Libov, M.D.; Ben-Ami Sela, Ph.D.; and Eliezer Witztum, M.D.

Background: Tardive dyskinesia (TD) is a significant clinical problem. Vitamin B₆ 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 B₆ versus placebo in a greater sample of patients for a longer time and (2) to evaluate the carryover effect of vitamin B₆.

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 B₆ (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 Extrapyramidal 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 B₆ 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 B₆ appears to be effective in reducing symptoms of TD. The specific mechanisms by which vitamin B₆ attenuates symptoms of TD are not clear.

(J Clin Psychiatry 2007;68:1648-1654)

Received Jan. 4, 2007; accepted Feb. 21, 2007. From the 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 (Drs. Lerner, Miodownik, Kaptsan, Bersudsky, Libov, and Witztum); and the Institute of Chemical Pathology, Sheba Medical Center, Tel Ha-Shomer, and Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv (Dr. Sela), Israel.

The study was supported by a Clinical Trials Grant from the Stanley Medical Research Institute, Bethesda, Md. (As principal investigator, Dr. Lerner had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.)

The authors report no additional financial or other relationship relevant to the subject of this article.

Corresponding author and reprints: Vladimir Lerner, M.D., Ph.D., Be'er-Sheva Mental Health Center, P.O. Box 4600, Be'er-Sheva, 84170, Israel (e-mail: lernervld@yahoo.com).