NCT00202280

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2004

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 14, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

November 20, 2015

Status Verified

November 1, 2015

Enrollment Period

2 years

First QC Date

September 14, 2005

Last Update Submit

November 18, 2015

Conditions

First Episode Psychosis

Outcome Measures

Primary Outcomes (2)

  • Cognition (MATRICS and COGSTATE)at 3 months

  • Symptomatology at 3 months

Secondary Outcomes (2)

  • Safety at 3 months

  • Tolerability at 3 months

Study Arms (2)

Placebo pill

PLACEBO COMPARATOR

Placebo pill daily for 3 months

Drug: Folic Acid 5mg, Vitamin B12 0.4mg and B6 50mg

5mg folic acid, 0.4mg B12, 50mg B6

EXPERIMENTAL

5mg folic acid, 0.4mg B12, 50mg B6 in one pill, daily for 3 months

Drug: Folic Acid 5mg, Vitamin B12 0.4mg and B6 50mg

Interventions

Folic Acid 5mg, Vitamin B12 0.4mg and B6 50mgDRUG
5mg folic acid, 0.4mg B12, 50mg B6Placebo pill

Eligibility Criteria

Age15 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Male and females
  • Between 15 and 25 years of age
  • First Episode Psychosis
  • months of treatment
  • Attending ORYGEN Youth Health, a geographical based catchment area service for young people aged between 15 and 25

You may not qualify if:

  • Untreated B12 deficiency or untreated pernicious anaemia
  • Patients on multi-vitamins, single B6, or folic acid, unless willing to discontinue and take study supplement
  • Chronic haemolytic states such as thalassaemia major or sickle-cell anaemia
  • Hypersensitivity to folic acid
  • Organic disorders presenting with a psychotic syndrome (e.g. brain tumour, temporal lobe epilepsy, HIV encephalopathy)
  • Mental retardation (unable and/or unlikely to give appropriate information of symptomatology or side-effects (IQ approximately lower than 70)
  • History of clinically significant physical illness (e.g. terminal cancer, renal dialysis)
  • History of brain surgery
  • History of brain infarction
  • Pregnant or lactating women, or women of childbearing potential not using an acceptable method of contraception

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ORYGEN Youth Health

Melbourne, Victoria, 3052, Australia

Location

Related Publications (1)

  • 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.

    PMID: 30771856DERIVED

MeSH Terms

Interventions

Folic AcidVitamin B 12

Intervention Hierarchy (Ancestors)

PterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsCorrinoidsTetrapyrrolesPyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds, 4 or More RingsMacrocyclic CompoundsPolycyclic Compounds

Study Officials

  • Dr Colin P O'Donnell, MB,MRCPsych

    ORYGEN Research Centre , ORYGEN Youth Health,Department of Psychiatry, University of Melbourne

    PRINCIPAL INVESTIGATOR

  • Prof Patrick D McGorry, PhD FRANZP

    ORYGEN Research Centre , ORYGEN Youth Health,Department of Psychiatry, University of Melbourne

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 20, 2005

Study Start

September 1, 2004

Primary Completion

September 1, 2006

Study Completion

June 1, 2009

Last Updated

November 20, 2015

Record last verified: 2015-11

Locations

AU(1)