T44. A RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF THE EFFECTS OF VITAMIN B12, B6 AND FOLIC ACID ON COGNITION AND SYMPTOMS IN FIRST-EPISODE PSYCHOSIS: THE VITAMINS IN PSYCHOSIS STUDY

Abstract

Vitamin B12, vitamin B6 and folic acid are homocysteine-reducing agents. Supplementation in chronic schizophrenia has shown that folate plus vitamin B12 can improve cognition and clinical symptoms. This study investigated whether adjunctive vitamin B12, B6 and folic acid lowers homocysteine and improves symptomatology and cognition in first-episode psychosis (FEP). This was a randomised, doubleblind, placebo-controlled trial conducted at the Early Psychosis Prevention and Intervention Centre, Melbourne, Australia. One hundred FEP patients aged 15-26 were randomised to receive folic acid 5mg, vitamin B12 0.4mg, and vitamin B6 50mg (N = 52) or placebo (N = 48), taken once-daily for 12 weeks, adjunct to anti-psychotics. Coprimary outcomes were change in composite cognition measured via a battery of 11 tests and total symptomatology (PANSS) over 12 weeks. Secondary outcomes included additional cognitive, symptom, functioning, tolerability and safety measures. Vitamin supplementation reduced homocysteine levels in the vitamin group over 12 weeks. The homocysteine lowering effects of the vitamins did not confer a major advantage over placebo therapy in improving the coprimary PANSS (p = .75) or composite cognition (p = 0.79). There was no significant group difference in secondary symptom domains. There was a significant group difference in the attention/vigilance domain (p = .024), whereby the vitamin group remained stable in their performance, whereas the placebo group declined. Vitamin supplementation appears well tolerated and safe and lowers homocysteine levels in in FEP. While supplementation may not offer extra benefits with respect to psychopathology and global cognition, folic acid, B12 and B6 may benefit the cognitive domain of attention/vigilance in people with FEP.