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NCT03287778 · ClinicalTrials.gov registry record · NA
Randomized Controlled Trial of Pyridoxine for Tardive Dyskinesia
A NA study, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- NA
- Development phase
- 17
- Enrollment target
NCT03287778 is a NA study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 17 participants.
The verdict
NCT03287778, a NA study, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- NA
- Development phase
- 17 participants
- Enrollment target
Study 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 will test the efficacy of pyridoxine (also known as vitamin B6) for TD. This will be an 8 week double-blind, placebo-controlled, randomized trial measuring the effect of pyridoxine 400 mg/day on the severity of involuntary muscle movements in people who meet Schooler-Kane criteria for TD. Participants: Approximately 50 subjects will be recruited from the UNC Schizophrenia Treatment and Evaluation Program (STEP) and other local psychiatric clinics. Procedures (methods): Symptoms of TD will be assessed using the Abnormal Involuntary Movement Scale (AIMS). Pharmacological Intervention: All participants who meet entry criteria will be randomized to one of two treatment groups: pyridoxine or placebo.
Interventions
- DIETARY_SUPPLEMENT Placebo
- DIETARY_SUPPLEMENT Pyridoxine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2017-12-01 |
| Est. Completion | 2022-12-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03287778
The ClinicalTrials.gov registry entry for NCT03287778 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03287778 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03287778 about?
NCT03287778 is a clinical study titled "Randomized Controlled Trial of Pyridoxine for Tardive Dyskinesia". 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 will test the efficacy of pyridoxine (also known as vitamin B6) for TD. This will be an 8 week double-...
What is the current status of trial NCT03287778?
This trial is currently completed. It is a NA study. The enrollment target is 17 participants. The study started on 2017-12-01. Estimated completion is 2022-12-30.
What interventions are being tested in trial NCT03287778?
The interventions under investigation include: Placebo (DIETARY_SUPPLEMENT), Pyridoxine (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT03287778?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
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