Status:
COMPLETED
Randomized Controlled Trial of Pyridoxine for Tardive Dyskinesia
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
Foundation of Hope, North Carolina
Conditions:
Tardive Dyskinesia
Antipsychotic Agents
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Purpose: Tardive dyskinesia (TD) is a involuntary movement disorder that can occur following long term treatment with antipsychotic medications and for which few treatment options exist. This study wi...
Detailed Description
Overview of Procedures: All procedures will be conducted at either the University of North Carolina Hospitals in Chapel Hill, or at the North Carolina Psychiatric Research Center (NCPRC), a specialize...
Eligibility Criteria
Inclusion
- Meet Schooler - Kane criteria for TD (at least one muscle group is rated at "moderate" severity or at least two muscle groups are rated at "mild" severity).
- Subjects must have \> or equal to 3 months of antipsychotic exposure.
- Other causes of involuntary movements have been ruled out.
- Psychiatrically stable as defined by outpatient status for \> or equal to 2 months.
- No change in dopamine antagonist agent or dose for \> or equal to 2 months or change in other prescribed medications for \> or equal to 1 month prior to enrollment
- Patients must be 18-80 years of age.
- Patients must demonstrate adequate decisional capacity to make a choice about participating in this research study and must provide written informed consent to participate.
- Women who can become pregnant must be using an adequate method of contraception to avoid pregnancy throughout the study. Acceptable methods include oral, injectable or implanted contraceptives, intrauterine devices or barrier methods such as condoms, diaphragm and spermicides. Women who can become pregnant must have a negative serum beta human chorionic gonadotropin (β-HCG) pregnancy test at the Screening Visit.
Exclusion
- Inpatient status
- Clinical Global Impression Severity (CGI-S) score \> or equal to 6.
- Evidence of any medical condition(s) that could confound the presence of TD.
- Currently taking more than 2 antipsychotic medications.
- Currently taking levodopa.
- Current or prior treatment with valbenazine or deutetrabenazine within the past 3 months.
- Current or prior treatment with pyridoxine within the past 3 months.
- Women who are pregnant or breastfeeding.
- Alcohol use disorder as determined by the SCID within the past month.
- Substance use disorder (except caffeine and nicotine) as determined by the SCID within the past month.
- No serious and unstable medical condition(s) in the judgment of the investigator.
- DSM-V diagnosis of intellectual disability, moderate or greater severity; or diagnosis of major neurocognitive disorder.
Key Trial Info
Start Date :
December 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2022
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT03287778
Start Date
December 1 2017
End Date
December 30 2022
Last Update
March 14 2023
Active Locations (1)
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1
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599