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

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.

Study Overview

• Status: Withdrawn
• Conditions: Tardive Dyskinesia
• Intervention / Treatment: Drug: Valbenazine

Detailed Description

This will be an Investigator-initiated, prospective, single center, interventional pilot study. This study will examine the feasibility of a larger study aimed at determining if there is an association between the improvement in tardive dyskinesia and the reduction in demoralization and subjective incompetence in patients with tardive dyskinesia after treatment with Valbenazine. Participants in that larger study will be treated with Valbenazine for a total of 7 weeks.

• Study Type: Interventional
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 26 years to 84 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Valbenazine; All participants will be treated with Valbenazine for 6 weeks.	Drug: Valbenazine; All participants will be treated with Valbenazine for 6 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in demoralization Scale	The change in symptoms of demoralization will be measured using the Demoralization Scale-II (DS-II). Scale scores range from 0 (minimum) to 32 (maximum), with higher scores indicating more demoralization (i.e., a worse outcome). Reduction of score to below 10 will be measured	Baseline, week 2, week 4, and week 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in subjective incompetence scale (SIS) score	The SIS consists of 12 items, each item has 4 response alternatives scored as 0, 1, 2, 3. The scores range from 0 to 36. Higher scores mean more severe subjective incompetence.	Baseline, week 2, week 4, and week 6

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: Neurocrine Biosciences
• Investigators: Principal Investigator: John De Figueiredo, MD, Clinical Professor of Psychiatry

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2024
• Primary Completion (Estimated): October 18, 2025
• Study Completion (Estimated): October 18, 2025

Study Registration Dates

• First Submitted: September 13, 2021
• First Submitted That Met QC Criteria: September 13, 2021
• First Posted (Actual): September 22, 2021

Study Record Updates

• Last Update Posted (Actual): July 11, 2025
• Last Update Submitted That Met QC Criteria: July 9, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Dyskinesia, Drug-Induced; Tardive Dyskinesia; Dyskinesias
• Other Study ID Numbers: 2000031423 (Yale); No NIH funding (Other Identifier: 11.09.23)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data will be shared after a reasonable request and after the project is completed. It will be shared with the sponsor and deposited .

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No