Efficacy of Treating First Episode Psychosis With Folic Acid,B12 and B6 in Addition to Antipsychotic Medication

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Melbourne Health
• Collaborator: Stanley Medical Research Institute
• Treatments: Folic Acid; Hydroxocobalamin; Vitamin B 12; Vitamin B Complex; Vitamins

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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