Efficacy of Treating First Episode Psychosis With Folic Acid,B12 and B6 in Addition to Antipsychotic Medication
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.
First Episode Psychosis
Drug: Folic Acid 5mg, Vitamin B12 0.4mg and B6 50mg
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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.|
- Cognition (MATRICS and COGSTATE)at 3 months
- Symptomatology at 3 months
- Safety at 3 months
- Tolerability at 3 months
|Study Start Date:||September 2004|
|Study Completion Date:||June 2009|
|Primary Completion Date:||September 2006 (Final data collection date for primary outcome measure)|
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
|Drug: Folic Acid 5mg, Vitamin B12 0.4mg and B6 50mg|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00202280
|ORYGEN Youth Health|
|Melbourne, Victoria, Australia, 3052|
|Principal Investigator:||Dr Colin P O'Donnell, MB,MRCPsych||ORYGEN Research Centre , ORYGEN Youth Health,Department of Psychiatry, University of Melbourne|
|Study Director:||Prof Patrick D McGorry, PhD FRANZP||ORYGEN Research Centre , ORYGEN Youth Health,Department of Psychiatry, University of Melbourne|