Vitamin B6 and B12 in the Treatment of Movement Disorders Induced by Antipsychotics
Status:
Unknown status
Trial end date:
2021-11-03
Target enrollment:
Participant gender:
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.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara
Treatments:
Antipsychotic Agents Hydroxocobalamin Pyridoxal Pyridoxine Vitamin B 12 Vitamin B 6 Vitamin B Complex Vitamins