Randomized Controlled Trial of Pyridoxine for Tardive Dyskinesia

NCT03287778 | Completed

• 1 other identifier: 17-1500
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Tardive Dyskinesia; Antipsychotic Agents

Keywords

Pyridoxine; Vitamin B6; Neurologic Manifestations; Involuntary Movements; Movement Disorder; Dyskinesias; Physiological Effects of Drugs; Psychotic Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Signs and Symptoms

Outcome Measures

Primary Outcomes (1)

• Mean Difference in AIMS scores

  Mean difference in Abnormal Involuntary Movement Scale (AIMS) total scores in participants assigned to pyridoxine and participants assigned to placebo from baseline to Week 8. The severity of TD symptoms is assessed by the Abnormal Involuntary Movement Scale (AIMS) total score (sum of items 1 through 7). The AIMS total dyskinesia score rates a total of 7 items, rating involuntary movement from 0 (no dyskinesia) to 4 (severe dyskinesia). Items 1 through 7 include facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). The AIMS dyskinesia total score for Items 1-7 ranges from 0 to 28; a higher score reflects increased severity.

  Baseline, Week 8

Secondary Outcomes (2)

• Mean Difference in Barnes Akathisia Rating Scale Scores

  Baseline, Week 8

• Mean Difference in Simpson Angus Scale Scores

  Baseline, Week 8

Study Arms (2)

Pyridoxine

ACTIVE COMPARATOR

Pyridoxine will be administered in dosages of 200 mg with a maximum dose of 400 mg.

Dietary Supplement: Pyridoxine

Placebo

PLACEBO COMPARATOR

Matching placebos will be administered for each active drug.

Dietary Supplement: Placebo

Interventions

Pyridoxine DIETARY_SUPPLEMENT

Max dose of 400 mg QD PO

Also known as: Vitamin B6

Pyridoxine

Placebo DIETARY_SUPPLEMENT

Matching placebos will be administered.

Also known as: Sugar pill

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Foundation of Hope, North Carolina: collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (1)

• Lerner V, Miodownik C, Kaptsan A, Cohen H, Matar M, Loewenthal U, Kotler M. Vitamin B(6) in the treatment of tardive dyskinesia: a double-blind, placebo-controlled, crossover study. Am J Psychiatry. 2001 Sep;158(9):1511-4. doi: 10.1176/appi.ajp.158.9.1511.

  PMID: 11532741 BACKGROUND

MeSH Terms

Conditions

Tardive Dyskinesia; Neurologic Manifestations; Dyskinesias; Movement Disorders; Psychotic Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Signs and Symptoms

Interventions

Pyridoxine; Vitamin B 6; Sugars

Condition Hierarchy (Ancestors)

Dyskinesia, Drug-Induced; Central Nervous System Diseases; Nervous System Diseases; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Picolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbohydrates

Study Officials

• Lars F Jarskog, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2017
• First Posted: September 19, 2017
• Study Start: December 1, 2017
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: March 14, 2023

Record last verified: 2023-03

Locations

US (1)