Efficacy of Treating First Episode Psychosis With Folic Acid,B12 and B6 in Addition to Antipsychotic Medication
Condition: First Episode Psychosis
MeSH terms: Psychotic Disorders; Mental Disorders
Study type: Interventional
Phase: Phase 2/Phase 3

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.
    

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.
    

Intervention name(s): Folic Acid 5mg, Vitamin B12 0.4mg and B6 50mg
Intervention type(s): Drug
Intervention MeSH terms: Folic Acid; Vitamin B 12; Hydroxocobalamin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment