A Phase 2/3 interventional study of Folic Acid 5mg, Vitamin B12 0.4mg and B6 50mg in First Episode Psychosis, sponsored by Melbourne Health. Completed at 1 site in Australia. Open to participants aged 15 Years to 25 Years. Per ClinicalTrials.gov, last updated 2015-11-20.
Sponsored by Melbourne Health · Phase 2/3, Interventional, and Treatment
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.
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.
1,626 studies on the registry are indexed under Psychotic Disorders; 293 are open to participants now.
This study's enrollment of 120 is above the median of 70 across 1,333 interventional studies indexed under Psychotic Disorders.
Browse Psychotic Disorders studies →Melbourne Health is the lead sponsor of 59 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
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 in one pill, daily for 3 months
Drug: Folic Acid 5mg, Vitamin B12 0.4mg and B6 50mg
Cognition (MATRICS and COGSTATE)at 3 months
Symptomatology at 3 months
Safety at 3 months
Tolerability at 3 months
This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
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