Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00202280
Status:
COMPLETED
Last Update Posted:
2015-11-20
First Post:
2005-09-14
Brief Title:
Efficacy of Treating First Episode Psychosis With Folic AcidB12 and B6 in Addition to Antipsychotic Medication
Sponsor:
Melbourne Health
Organization:
Melbourne Health
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2015-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether Vitamin B12B6 and Folic Acid are effective with antipsychotic medication in the treatment of First Episode PsychosisThe 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 04 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
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 04 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 03T-472 | OTHER_GRANT | Stanley Medical Research Institute | None |