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

NCT03790345 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2019-12-18

No results posted yet for this study

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.

Conditions

  • Schizophrenia
  • Drug Induced Movement Disorder, Unspecified
  • Oxidative Stress

Interventions

DRUG

Pyridoxine

Adjuvant daily treatment with 200mg of pyridoxine

DRUG

Cobalamin

Adjuvant daily treatment with 2mg of cobalamin

DRUG

Placebo Oral Tablet

Adjuvant daily treatment with placebo

Sponsors & Collaborators

  • Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara

    lead OTHER

Principal Investigators

  • Lia LO Sanders, MD, PhD · Núcleo de Pesquisa e Desenvolvimento de Medicamentos

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03790345 on ClinicalTrials.gov