Randomized Controlled Trial of Pyridoxine for Tardive Dyskinesia

Learn more about:
Related Clinical Trial
Efficacy Study of Panax Ginseng to Boost Antipsychotics Effects in Schizophrenia The Potential for Clinical Dependence and Withdrawal Symptoms Associated With Valbenazine Dysport for the Treatment of OMD Validation of the Implantation of a New Electrode for the Treatment of Dystonia Smoking Cessation With Varenicline in Schizophrenia: Antipsychotic-Induced Neurological Symptoms as Correlates Safety and Tolerability Study of NBI-98854 for the Treatment of Tardive Dyskinesia Randomized Controlled Trial of Pyridoxine for Tardive Dyskinesia D-Serine Treatment For Tardive Dyskinesia Deep Brain Stimulation for Patients With Tardive Dyskinesia and or Dystonia Persistence of Effect and Safety of Valbenazine for the Treatment of Tardive Dyskinesia Levetiracetam Treatment of Tardive Dyskinesia The Assessment of Movement Disorders Utilizing Live Two-Way Video Real‐World Evaluation Screening Study and Registry of Dyskinesia in Patients Taking Antipsychotic Agents Xenazine in Late Dyskinetic Syndrome With Neuroleptics Safety and Efficacy of Propranolol in the Treatment of Tardive Dyskinesia Effect of tDCS on Cognition, Symptoms in Chronic Schizophrenia Patients With Tardive Dyskinesia Melatonin Treatment for Tardive Dyskinesia in Schizophrenia Extract of Ginkgo Biloba and Tardive Dyskinesia Aim to Reduce Movements in Tardive Dyskinesia Reducing Involuntary Movements in Tardive Dyskinesia A Phase 3 Study of NBI-98854 for the Treatment of Tardive Dyskinesia NBI-98854 Dose Titration Study for the Treatment of Tardive Dyskinesia Pyridoxal Kinase Activity in Tardive Dyskinesia Rollover Study for Continuing Valbenazine (NBI-98854) Administration for the Treatment of Tardive Dyskinesia NBI-98854 for the Treatment of Tardive Dyskinesia in Subjects With Schizophrenia or Schizoaffective Disorder (KINECT Study) NBI-98854 for the Treatment of Tardive Dyskinesia in Subjects With Schizophrenia or Schizoaffective Disorder Repetitive Transcranial Magnetic Stimulation for the Treatment of the Tardive Dyskinesia. Efficacy and Safety of NBI-98854 in Subjects With Tardive Dyskinesia Efficacy and Safety of MT-5199 in Subjects With Tardive Dyskinesia Piracetam for Treatment Tardive Dyskinesia Treatment of Tardive Dyskinesia With Galantamine Tardive Dyskinesia and Cognitive Function Safety and Efficacy of Pyridoxal 5′ -Phosphate in the Treatment of Tardive Dyskinesia Addressing Involuntary Movements in Tardive Dyskinesia Efficacy of Docosahexaenoic Acid on Tardive Dyskinesia

Brief Title

Randomized Controlled Trial of Pyridoxine for Tardive Dyskinesia

Official Title

Randomized Controlled Trial of Pyridoxine for Tardive Dyskinesia

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.
    

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 specialized program of the University of North Carolina Center for Excellence in
      Community Mental Health, in Raleigh.

      Screening: During the initial clinic visit and after providing written informed consent,
      prospective subjects' psychiatric and medical histories will be reviewed, physical exams
      conducted, demographics and vital signs obtained, and blood and urine collected. The
      Structured Clinical Interview for DSM-V, the Columbia Suicide Severity Rating Scale (C-SSRS),
      and the Clinical Global Impressions-Severity (CGI-S) will be used to evaluate
      psychopathology. Involuntary muscle movements will be assessed using the Abnormal Involuntary
      Movement Scale (AIMS). The AIMS exam will be video recorded. Other neurological side effects
      of antipsychotic medications will be assessed using the Barnes Akathisia Scale (BARS) and
      Simpson-Angus Scale (SAS).

      The baseline visit will be scheduled within 28 days of the screening visit. Vital signs and
      weight will be measured. A blood test to measure baseline pyridoxine level will be collected.
      A battery of assessments will be administered including the Clinical Global
      Impressions-Severity (CGI-S), the Alcohol Use Scale, Substance Use Scale, Brief Psychiatric
      Rating Scale (BPRS), Columbia Suicide Severity Rating Scale (C-SSRS), AIMS (video recorded),
      BARS, and SAS.

      At the completion of the baseline visit, subjects who continue to meet study inclusion
      criteria will be randomized to one of two treatment groups (pyridoxine or placebo). Subjects
      assigned to the pyridoxine group will receive 200 mg per day for one week and then 400 mg per
      day, as tolerated, for the remainder of the study. Subjects assigned to the placebo group
      will receive matching placebo capsules.

      After study enrollment, subjects will be scheduled for Week 1 and Week 2 study visits. The
      purpose of these visits will be to assess medication management (i.e., adverse events/side
      effects, adherence), collect vital signs, assess current psychiatric status, and assess
      neurological symptoms using the AIMS (video recorded), BARS, and SAS. The CGI-S will be
      performed at both Week 1 and Week 2, however, the C-SSRS will be completed at Week 2 only.

      Study visit at Week 4 and end-of-study visit at Week 8 will be similar to Week 2, with the
      addition of the BPRS, Substance Use Scale and Alcohol Use Questionnaire. A blood test to
      measure pyridoxine levels will also be collected during these visits. Study drug is
      discontinued at the Week 8 visit.

      A follow-up visit at Week 10, two weeks after stopping the treatment, will consist of
      assessing for adverse events/side effects, collecting vital signs, administrating the CGI-S
      and C-SSRS, and performing the AIMS (video recorded), BARS, and SAS. The follow-up visit will
      help determine whether the potential benefits of pyridoxine for TD may continue after
      treatment is discontinued.

      Vital signs, adverse events, and side effects will be obtained at all in-person study visits.
      Blood collection and laboratory testing will be done at Screening, Baseline, Week 4, and Week
      8 .
    


Study Type

Interventional


Primary Outcome

Mean Difference in AIMS scores

Secondary Outcome

 Mean Difference in Barnes Akathisia Rating Scale Scores

Condition

Tardive Dyskinesia

Intervention

Pyridoxine

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Dietary Supplement

Estimated Enrollment

50

Start Date

December 1, 2017

Completion Date

June 30, 2021

Primary Completion Date

June 1, 2021

Eligibility Criteria

        Inclusion Criteria:

          -  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 Criteria:

          -  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.
      

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Lars F Jarskog, MD, 919-843-7683, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03287778

Organization ID

17-1500


Responsible Party

Sponsor

Study Sponsor

University of North Carolina, Chapel Hill

Collaborators

 Foundation of Hope, North Carolina

Study Sponsor

Lars F Jarskog, MD, Principal Investigator, University of North Carolina, Chapel Hill


Verification Date

March 2021