Efficacy of Treating First Episode Psychosis With Folic Acid,B12 and B6 in Addition to Antipsychotic Medication

NCT00202280 ↗

Phase 2/3 Completed 120 enrolled Melbourne Health Stanley Medical Research Institute · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to determine whether Vitamin B12,B6 and Folic Acid are effective with antipsychotic medication in the treatment of First Episode Psychosis.The B-complex Vitamins' homocysteine lowering properties may have an effect on cognition and symptoms. We are examining changes in symptoms and cognition over a 3 month period.

Timeline

Start: 2004-09
Primary completion: 2006-09
Completion: 2009-06

Outcome

Missed primary endpoint

paper B-vitamin supplementation had no significant effects on Positive and Negative Syndrome Scale total (p = .749) PMID 30771856 ↗

paper or composite neurocognition (p = .785). PMID 30771856 ↗

Publications

Allott K, McGorry PD, Yuen HP, Firth J, Proffitt TM, Berger G, Maruff P, O'Regan MK, Papas A, Stephens TCB, O'Donnell CP. 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. Biol Psychiatry. 2019 Jul 1;86(1):35-44. doi: 10.1016/j.biopsych.2018.12.018. Epub 2019 Jan 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	B6	Other / unclassified	50 mg	—
Subject	Vitamin B12	Other / unclassified	0.4 mg	—
Subject	folic acid	Other / unclassified	5 mg	—