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Biol Psychiatry. 2019 Jan 9. pii: S0006-3223(19)30001-0. doi: 10.1016/j.biopsych.2018.12.018. [Epub ahead of print]

The Vitamins in Psychosis Study: A Randomized, Double-Blind, Placebo-Controlled Trial of the Effects of Vitamins B12, B6, and Folic Acid on Symptoms and Neurocognition in First-Episode Psychosis.

Author information

1
Orygen, The National Centre of Excellence in Youth Mental Health, The University of Melbourne, Parkville, Victoria, Australia; Centre for Youth Mental Health, The University of Melbourne, Parkville, Victoria, Australia.
2
Orygen, The National Centre of Excellence in Youth Mental Health, The University of Melbourne, Parkville, Victoria, Australia; Centre for Youth Mental Health, The University of Melbourne, Parkville, Victoria, Australia; NICM Health Research Institute, Western Sydney University, Sydney, New South Wales, Australia.
3
Orygen, The National Centre of Excellence in Youth Mental Health, The University of Melbourne, Parkville, Victoria, Australia; Centre for Youth Mental Health, The University of Melbourne, Parkville, Victoria, Australia; School of Psychology, University of Waikato, Hamilton, Waikato, New Zealand.
4
Department of Child and Adolescent Psychiatry, Psychiatric University Clinic, Zurich, Switzerland.
5
Department of Anatomy and Neuroscience, The University of Melbourne, Parkville, Victoria, Australia.
6
Department of Psychiatry, Donegal Mental Health Service, Letterkenny University Hospital, Letterkenny, Donegal, Republic of Ireland. Electronic address: drcolinodonnell@yahoo.com.

Abstract

BACKGROUND:

Elevated homocysteine is observed in schizophrenia and associated with illness severity. The aim of this study was to determine whether vitamins B12, B6, and folic acid lower homocysteine and improve symptomatology and neurocognition in first-episode psychosis. Whether baseline homocysteine, genetic variation, sex, and diagnosis interact with B-vitamin treatment on outcomes was also examined.

METHODS:

A randomized, double-blind, placebo-controlled trial was used. A total of 120 patients with first-episode psychosis were randomized to an adjunctive B-vitamin supplement (containing folic acid [5 mg], B12 [0.4 mg], and B6 [50 mg]) or placebo, taken once daily for 12 weeks. Coprimary outcomes were change in total symptomatology (Positive and Negative Syndrome Scale) and composite neurocognition. Secondary outcomes included additional measures of symptoms, neurocognition, functioning, tolerability, and safety.

RESULTS:

B-vitamin supplementation reduced homocysteine levels (p = .003, effect size = -0.65). B-vitamin supplementation had no significant effects on Positive and Negative Syndrome Scale total (p = .749) or composite neurocognition (p = .785). There were no significant group differences in secondary symptom domains. A significant group difference in the attention/vigilance domain (p = .024, effect size = 0.49) showed that the B-vitamin group remained stable and the placebo group declined in performance. In addition, 14% of the sample had elevated baseline homocysteine levels, which was associated with greater improvements in one measure of attention/vigilance following B-vitamin supplementation. Being female and having affective psychosis was associated with improved neurocognition in select domains following B-vitamin supplementation. Genetic variation did not influence B-vitamin treatment response.

CONCLUSIONS:

While 12-week B-vitamin supplementation might not improve overall psychopathology and global neurocognition, it may have specific neuroprotective properties in attention/vigilance, particularly in patients with elevated homocysteine levels, patients with affective psychosis, and female patients. Results support a personalized medicine approach to vitamin supplementation in first-episode psychosis.

KEYWORDS:

Attention; B vitamins; Early psychosis; Folic acid; Genetics; Homocysteine

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