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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00202280




Registration number
NCT00202280
Ethics application status
Date submitted
14/09/2005
Date registered
20/09/2005
Date last updated
20/11/2015

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
03T-472
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

Intervention/exposure
Study type
Interventional
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

Outcomes
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

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
No
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
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

Study design
Purpose of the study
Treatment
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
Parallel
Other design features
Phase
Phase 2/Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2009
Sample size
Target
Accrual to date
Final
120
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
ORYGEN Youth Health - Melbourne
Recruitment postcode(s) [1] 0 0
3052 - Melbourne

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

Ethics approval
Ethics application status

Summary
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
https://clinicaltrials.gov/ct2/show/NCT00202280
Trial related presentations / publications
Public notes

Contacts
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