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

• Status: Unknown status
• Trial end date: 2021-11-03
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

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

Criteria

Inclusion Criteria:

• Capacity to provide informed consent;

• Schizophrenia diagnosis (confirmed by Structured Clinical Interview (SCID);

• Movement disorders induced by psychotropic drugs of at least moderate severity;

• Exposure to psychotropic medication for at least three months prior of the appearance of movement disorders;.

• Disorders of movement for at least one year;

• Stable psychotropic regimen for at least one month prior to study entry.

Exclusion Criteria:

• 6-month history of any drug or alcohol abuse or dependence;

• Changes in psychotropic medications within the last 4 weeks;

• General medical illness including autoimmune disorders, known chronic infections such as HIV or hepatitis C, and liver or renal failure that could adversely impact on patient outcome;

• Women who are planning to become pregnant, are pregnant, or are breastfeeding.