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

What Was Tested

This registered phase 2, phase 3 trial tested Cyanocobalamin (Vitamin B12).

The researchers are examining changes in symptoms and cognition over a 3 month period.

It had two arms (groups): Placebo pill (placebo comparator) and one (experimental).

Placebo pill daily for 3 months.

The registry classes the interventions as drug.

More on the Plan

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 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.

Who Took Part

120 actual participants took part.

It was open to people of any sex aged from 15 years up to 25 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Male and females. Between 15 and 25 years of age. First Episode Psychosis. 3 months of treatment.

The full record lists 5 inclusion and 10 exclusion criteria; among the exclusions: 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.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

The participants were allocated by chance, so the Cyanocobalamin (Vitamin B12) group and the comparison group should start out alike.

The Cyanocobalamin (Vitamin B12) group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Cyanocobalamin (Vitamin B12), so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2004-09 with completion listed for 2006-09.

It ran at 1 site in Australia.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Cognition (MATRICS and COGSTATE)at 3 months. Symptomatology at 3 months.

It also tracked 2 secondary outcomes, for example Safety at 3 months and Tolerability at 3 months.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Cyanocobalamin (Vitamin B12) in 120 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Cyanocobalamin (Vitamin B12) compound page, all human trials.