drugset / Trial / NCT03790345

Vitamin B6 and B12 in the Treatment of Movement Disorders Induced by Antipsychotics

NCT03790345

RandomizedParallel-groupQuadruple-blindTreatment

Summary

D2 dopaminergic receptor blockers, used to treat schizophrenia, can lead to the onset of movement disorders. Drug-induced movement disorders encompass several syndromes. Parkinsonism, dystonia, dyskinesia and akathisia are the most prevalent. All of them lead to poor adherence to the treatment instituted, decrease in the quality of life, relapses and hospitalizations. The pathophysiology of drug-induced movement disorders is complex and poorly understood, but seems to be associated with oxidative stress, as a result of an increase in free radicals generated from dopamine metabolism. Treatment strategies following the onset of drug-induced movement disorders include neuroleptic discontinuation, use of atypical antipsychotics and anticholinergics. A pre-clinical study showed that the antioxidant properties of vitamins B6 and B12, alone or in combination, prevented the development of orofacial dyskinesia induced by haloperidol. This clinical trial aims to evaluate the effects of vitamins B6 and B12 on the treatment of patients diagnosed with schizophrenia, schizoaffective or bipolar disorder who present with tardive dyskinesia, dystonia and parkinsonism.

Timeline

Start
2019-09-03
Primary completion
2020-06-03
Completion
2021-11-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Cobalamin Small molecule 2 mg
Subject Pyridoxine Unknown 200 mg