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Trial details imported from

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Registration number
Ethics application status
Date submitted
Date registered
Date last updated

Titles & IDs
Public title
Efficacy of Treating First Episode Psychosis With Folic Acid,B12 and B6 in Addition to Antipsychotic Medication
Scientific title
VIP (Vitamins In Psychosis) Study. A Randomized Double Blind Placebo Controlled Trial of the Effects of Vitamin B12, B6 and Folic Acid Augmentation on Cognition and Symptoms in Early Psychosis.
Secondary ID [1] 0 0
Secondary ID [2] 0 0
BPREC 26/2004
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
First Episode Psychosis 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Psychosis and personality disorders

Study type
Description of intervention(s) / exposure
Treatment: Drugs - Folic Acid 5mg, Vitamin B12 0.4mg and B6 50mg

Placebo Comparator: Placebo pill - Placebo pill daily for 3 months

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

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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Primary outcome [1] 0 0
Cognition (MATRICS and COGSTATE)at 3 months
Timepoint [1] 0 0
Primary outcome [2] 0 0
Symptomatology at 3 months
Timepoint [2] 0 0
Secondary outcome [1] 0 0
Safety at 3 months
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Tolerability at 3 months
Timepoint [2] 0 0

Key inclusion criteria
- Male and females

- Between 15 and 25 years of age

- First Episode Psychosis

- 3 months of treatment

- Attending ORYGEN Youth Health, a geographical based catchment area service for young
people aged between 15 and 25
Minimum age
15 Years
Maximum age
25 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
- 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

- History of brain surgery

- History of brain infarction

- Pregnant or lactating women, or women of childbearing potential not using an
acceptable method of contraception

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase 2/Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
ORYGEN Youth Health - Melbourne
Recruitment postcode(s) [1] 0 0
3052 - Melbourne

Funding & Sponsors
Primary sponsor type
Melbourne Health
Other collaborator category [1] 0 0
Name [1] 0 0
Stanley Medical Research Institute
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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 website
Trial related presentations / publications
Public notes

Principal investigator
Name 0 0
Dr Colin P O'Donnell, MB,MRCPsych
Address 0 0
ORYGEN Research Centre , ORYGEN Youth Health,Department of Psychiatry, University of Melbourne
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications