First Episode PsychosisPhase 2/3NCT00202280
Efficacy of Treating First Episode Psychosis With Folic Acid,B12 and B6 in Addition to Antipsychotic Medication
A Phase 2/3 study testing Folic Acid 5mg, Vitamin B12 0.4mg and B6 50mg in people with First Episode Psychosis, run by Melbourne Health at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 25 years
- Conditions the study is for
- First Episode Psychosis
- What is being tested?
- Folic Acid 5mg, Vitamin B12 0.4mg and B6 50mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteAustralia
- Study dates
- Sep 2004to Jun 2009
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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.
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.
Read the detailed description
The core rationale of this study will be to prospectively investigate whether Vitamin B12, B6 and Folic Acid and the associated lowering of homocysteine levels will improve and /or protect cognitive functioning in a cohort of 120 first episode psychosis patients.
This is a randomized, double blind placebo controlled add on standard therapy trial with vitamin B12, B6 and folic acid, in young patients between 15-25 presenting to ORYGEN Youth Health with a first psychotic episode . Vitamins (B12 , B6 and Folate) will be compared with placebo added to standard treatment for a period of 12 weeks in a double blind fashion. Primary outcome measures will be psychopathology and cognition (CogState and MATRICS). Secondary outcome measures will be tolerability and safety measures (drop-out rates, general side effect scale (UKU).
Patients who give informed consent will be randomised to receive treatment with vitamin (5 mg folic acid, 0.4 mg B12, and 50 mg B6) daily or placebo for 12 weeks.
Patients will be randomised by a dynamic randomisation method called minimization which allocates patients to treatment group by checking the allocation of similar patients already randomised, and allocating the next treatment group "live" to best balance the treatment groups across all stratification variables. The minimization will be carried out by the NHMRC clinical trials centre in Sydney , and the patient will be randomized to either placebo or vitamin. Each patient will collect their tablets from the clinical trials pharmacy. The Clinical Trials Pharmacy will dispense either vitamin or placebo. All study personnel and participants will be blinded to treatment assignment for the duration of the study. To enhance the quality of measurement (and increase the power of the study by avoiding dilution of effect) adherence to medication will be measured electronically with electronic pill caps (Medication Event Monitoring System VI, ARRDEX Ltd). This will allow us to assess actual pharmacological exposure in an objective manner.
- Conditions
- First Episode Psychosis
- Being tested
- Folic Acid 5mg, Vitamin B12 0.4mg and B6 50mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Folic Acid 5mg, Vitamin B12 0.4mg and B6 50mgDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo pill | Placebo comparator | Placebo pill daily for 3 months Receives: 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 Receives: Drug: Folic Acid 5mg, Vitamin B12 0.4mg and B6 50mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognition (MATRICS and COGSTATE)at 3 months
Symptomatology at 3 months
Secondary outcomes (2)
Safety at 3 months
Tolerability at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startSep 2004
- Primary completionSep 2006
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for First Episode PsychosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Melbourne Health
- Sponsor type
- University, hospital or other
- Collaborators
- Stanley Medical Research Institute
- Responsible party
- Sponsor
- Investigators
- Dr Colin P O'Donnell, MB,MRCPsych, Principal investigator, ORYGEN Research Centre , ORYGEN Youth Health,Department of Psychiatry, University of MelbourneProf Patrick D McGorry, PhD FRANZP, Study director, ORYGEN Research Centre , ORYGEN Youth Health,Department of Psychiatry, University of Melbourne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00202280
- Sponsor's protocol ID
- BPREC 26/2004
- Other IDs
- 03T-472
- Status last verified
- Nov 2015
- First submitted
- 14 Sep 2005
- Last updated
- 20 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 30771856
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT00202280
- Acronym / sponsor ID
- BPREC 26/2004
- Conditions
- First Episode Psychosis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Melbourne HealthUniversity, hospital or other
- Collaborators
- Stanley Medical Research Institute
- Study start
- Sep 2004
- Primary completion
- Sep 2006 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The core rationale of this study will be to prospectively investigate whether Vitamin B12, B6 and Folic Acid and the associated lowering of homocysteine levels will improve and /or protect cognitive functioning in a cohort of 120 first episode psychosis patients.
This is a randomized, double blind placebo controlled add on standard therapy trial with vitamin B12, B6 and folic acid, in young patients between 15-25 presenting to ORYGEN Youth Health with a first psychotic episode . Vitamins (B12 , B6 and Folate) will be compared with placebo added to standard treatment for a period of 12 weeks in a double blind fashion. Primary outcome measures will be psychopathology and cognition (CogState and MATRICS). Secondary outcome measures will be tolerability and safety measures (drop-out rates, general side effect scale (UKU).
Patients who give informed consent will be randomised to receive treatment with vitamin (5 mg folic acid, 0.4 mg B12, and 50 mg B6) daily or placebo for 12 weeks.
Patients will be randomised by a dynamic randomisation method called minimization which allocates patients to treatment group by checking the allocation of similar patients already randomised, and allocating the next treatment group "live" to best balance the treatment groups across all stratification variables. The minimization will be carried out by the NHMRC clinical trials centre in Sydney , and the patient will be randomized to either placebo or vitamin. Each patient will collect their tablets from the clinical trials pharmacy. The Clinical Trials Pharmacy will dispense either vitamin or placebo. All study personnel and participants will be blinded to treatment assignment for the duration of the study. To enhance the quality of measurement (and increase the power of the study by avoiding dilution of effect) adherence to medication will be measured electronically with electronic pill caps (Medication Event Monitoring System VI, ARRDEX Ltd). This will allow us to assess actual pharmacological exposure in an objective manner.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo pill | Placebo comparator | Drug: Folic Acid 5mg, Vitamin B12 0.4mg and B6 50mgPlacebo pill daily for 3 months |
| 5mg folic acid, 0.4mg B12, 50mg B6 | Experimental | Drug: Folic Acid 5mg, Vitamin B12 0.4mg and B6 50mg5mg folic acid, 0.4mg B12, 50mg B6 in one pill, daily for 3 months |
Who may qualify
- Ages
- 15 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Folic Acid 5mg, Vitamin B12 0.4mg and B6 50mg | Drug | 5mg folic acid, 0.4mg B12, 50mg B6, Placebo pill |
Primary outcome
Cognition (MATRICS and COGSTATE)at 3 months
Symptomatology at 3 months
2 secondary outcomes
Safety at 3 months
Tolerability at 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2015.
- Derived from this study: PubMed 30771856Allott 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Colin P O'Donnell, MB,MRCPsych principal investigator
ORYGEN Research Centre , ORYGEN Youth Health,Department of Psychiatry, University of Melbourne
Prof Patrick D McGorry, PhD FRANZP study director
ORYGEN Research Centre , ORYGEN Youth Health,Department of Psychiatry, University of Melbourne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Folic Acid 5mg, Vitamin B12 0.4mg and B6 50mg in people with First Episode Psychosis, run by Melbourne Health at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognition (MATRICS and COGSTATE)at 3 months. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00202280, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2015.