Status:
UNKNOWN
Vitamin B6 and B12 in the Treatment of Movement Disorders Induced by Antipsychotics
Lead Sponsor:
Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara
Conditions:
Schizophrenia
Drug Induced Movement Disorder, Unspecified
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
PHASE3
Brief 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, dyskin...
Detailed Description
D2 dopaminergic receptor blockers, used to treat schizophrenia, can lead to the onset of drug-induced movement disorders, such as parkinsonism, dystonia, dyskinesia and akathisia. They seem to be asso...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 3 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 3 2021
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT03790345
Start Date
September 3 2019
End Date
November 3 2021
Last Update
December 18 2019
Active Locations (1)
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1
Núcleo de Pesquisa e Desenvolvimento de Medicamentos - UFC
Fortaleza, Ceará, Brazil, 60430-275