Effect of High-Dose B-Complex Vitamins on the Symptoms of Schizophrenia

What Was Tested

The trial (not phased) is built around Cyanocobalamin (Vitamin B12).

It had two arms (groups): A (experimental) and B (placebo comparator).

Vitamin capsule.

Placebo capsule.

The registry classes the interventions as dietary supplement and other.

More on the Plan

Individuals with schizophrenia often experience disturbing residual symptoms, even with the best available current treatments.

Homocysteine, normally found in the body, can interfere with NMDA-glutamate receptor function, and this might be responsible for some of the symptoms of schizophrenia.

Who Took Part

The registry lists 50 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Clinical diagnosis of Schizophrenia or Schizoaffective Disorder. Ages 18-65, male or female. Treatment regimen includes a new-generation antipsychotic (clozapine, olanzapine,risperidone, quetiapine, ziprasidone or aripiprazole). Stable medication for 4 weeks prior to screening visit.

The full record lists 4 inclusion and 6 exclusion criteria; among the exclusions: diagnosis of active substance use disorder within the last month; pregnant or breastfeeding; seizure disorder.

How the Study Was Run

The set-up was randomized, parallel-group and triple-blind.

Random assignment meant chance, not the researchers, decided who got Cyanocobalamin (Vitamin B12) and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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, investigator and outcomes assessor.

It started in 2004-07 with completion listed for 2007-07.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): blood homocysteine levels (time frame: 12 weeks after baseline).

It also tracked 6 secondary outcomes, for example CDSS (Calgary Depression Scale for Schizophrenia), WAIS-II Memory Scale (Immediate and Delayed), WAIS Digit Symbol-Coding, Wisconsin Card Sorting Test and WAIS-II Letter-Number Sequencing Subtest.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Cyanocobalamin (Vitamin B12) in 50 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.