Status:
COMPLETED
Efficacy of Treating First Episode Psychosis With Folic Acid,B12 and B6 in Addition to Antipsychotic Medication
Lead Sponsor:
Melbourne Health
Collaborating Sponsors:
Stanley Medical Research Institute
Conditions:
First Episode Psychosis
Eligibility:
All Genders
15-25 years
Phase:
PHASE2
PHASE3
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' homocyst...
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 f...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00202280
Start Date
September 1 2004
End Date
June 1 2009
Last Update
November 20 2015
Active Locations (1)
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1
ORYGEN Youth Health
Melbourne, Victoria, Australia, 3052