Reduction of Demoralization in Patients With Tardive Dyskinesia After Treatment With Valbenazine

Last updated: January 22, 2025
Sponsor: Yale University
Overall Status: Active - Recruiting

Phase

1

Condition

Tardive Dyskinesia

Dyskinesias

Treatment

Valbenazine

Clinical Study ID

NCT05053321
2000031423
No NIH funding
2000031423
  • Ages 26-84
  • All Genders

Study Summary

This will be an Investigator-initiated pilot study in which participants will be assessed with various scales to measure demoralization, anxiety, depression, and subjective incompetence at baseline and every two weeks after treatment with Valbenazine for a total of 6 weeks. Improvement in TD will be assessed as well and correlated with reduction in demoralization.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age: 26-84

  2. Sex: Both males and females will be included

  3. Diagnosis of dopamine receptor-blocker induced tardive dyskinesia according to theDSM-5 criteria: "involuntary athetoid or choreiform movements lasting at least a fewweeks, developing in association with the use of a neuroleptic medication for atleast a few months, and persisting beyond 4-8 weeks"

Exclusion

Exclusion Criteria:

The following classes of patients will be excluded:

  1. Patients with unstable psychiatric status defined as having a total score on BPRS of 50 or higher

  2. Patients who have suicidal or homicidal ideation, intent, or plan or viewed ashaving a significant risk of suicidal or violent behavior;

  3. Patients with cognitive impairment as defined by a score of 24 or less on the MMSE

  4. Patients with current diagnosis of alcohol or substance use disorder made accordingto DSM-5 criteria

  5. Patients with clinically significant unstable medical condition defined as follows:a comorbid abnormal movement disorder more prominent than tardive dyskinesia (e.g.,parkinsonism, akathisia, truncal dystonia), a score of greater than 2 on two or moreitems of the Simpson-Angus Scale, or a history of neuroleptic malignant syndrome.

  6. Patients previously treated with Valbenazine or any other medication specificallyindicated for tardive dyskinesia

  7. Patients currently taking strong CYP3A4 inducers, dopamine agonists, MAO inhibitors,stimulants, and/or VMAT2 inhibitors

  8. Patients with congenital long QT syndrome or arrhythmias associated with prolongedQT interval

  9. Patients with risk factors for prolonged QT such as electrolyte abnormalities (hypokalemia, hypocalcemia, hypomagnesemia), anorexia nervosa, diuretic use, certainheart conditions, and other medical conditions

  10. Patients tested positive for Coronavirus Covid-19

  11. Patients with impaired decision-making capacity

  12. Institutionalized individuals

  13. Prisoners

Study Design

Total Participants: 15
Treatment Group(s): 1
Primary Treatment: Valbenazine
Phase: 1
Study Start date:
October 18, 2024
Estimated Completion Date:
October 18, 2025

Connect with a study center

  • Yale Church Street Research Unit.

    New Haven, Connecticut 06520
    United States

    Active - Recruiting

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