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

This study has been completed.
Sponsor:
Collaborator:
Stanley Medical Research Institute
Information provided by (Responsible Party):
Melbourne Health
ClinicalTrials.gov Identifier:
NCT00202280
First received: September 14, 2005
Last updated: May 28, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
First Episode Psychosis
Drug: Folic Acid 5mg, Vitamin B12 0.4mg and B6 50mg
Phase 2
Phase 3

Study Type: Interventional
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.

Resource links provided by NLM:


Further study details as provided by Melbourne Health:

Primary Outcome Measures:
  • Cognition (MATRICS and COGSTATE)at 3 months
  • Symptomatology at 3 months

Secondary Outcome Measures:
  • Safety at 3 months
  • Tolerability at 3 months

Enrollment: 120
Study Start Date: September 2004
Study Completion Date: June 2009
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   15 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00202280

Locations
Australia, Victoria
ORYGEN Youth Health
Melbourne, Victoria, Australia, 3052
Sponsors and Collaborators
Melbourne Health
Stanley Medical Research Institute
Investigators
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
  More Information

No publications provided

Responsible Party: Melbourne Health
ClinicalTrials.gov Identifier: NCT00202280     History of Changes
Other Study ID Numbers: BPREC 26/2004, 03T-472
Study First Received: September 14, 2005
Last Updated: May 28, 2013
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features
Folic Acid
Vitamin B Complex
Vitamin B 12
Hydroxocobalamin
Hematinics
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014