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

Description

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.

Conditions

Tardive Dyskinesia

Study Overview

Study Details

Study overview

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.

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

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

Condition
Tardive Dyskinesia
Intervention / Treatment

-

Contacts and Locations

New Haven

Yale Church Street Research Unit., New Haven, Connecticut, United States, 06520

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 the DSM-5 criteria: "involuntary athetoid or choreiform movements lasting at least a few weeks, developing in association with the use of a neuroleptic medication for at least a few months, and persisting beyond 4-8 weeks"
  • 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 as having 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 according to 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 more items of the Simpson-Angus Scale, or a history of neuroleptic malignant syndrome.
  • 6. Patients previously treated with Valbenazine or any other medication specifically indicated 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 prolonged QT interval
  • 9. Patients with risk factors for prolonged QT such as electrolyte abnormalities (hypokalemia, hypocalcemia, hypomagnesemia), anorexia nervosa, diuretic use, certain heart 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

Ages Eligible for Study

26 Years to 84 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Yale University,

John De Figueiredo, MD, PRINCIPAL_INVESTIGATOR, Clinical Professor of Psychiatry

Study Record Dates

2025-10-18