Reduction of Demoralization After Treatment of TD With Valbenazine

• Status: Not yet recruiting
• Trial end date: 2022-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this research project is to determine the feasibility of a larger study aimed at demonstrating that treatment of tardive dyskinesia with Valbenazine is associated with reduction of demoralization

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Collaborator: Neurocrine Biosciences

Criteria

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 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"

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 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