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

NCT05053321 | Withdrawn Phase 1 DMC FDA Drug

• 2 other identifiers: 2000031423No NIH funding
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tardive Dyskinesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in subjective incompetence scale (SIS) score

  Baseline, week 2, week 4, and week 6

Study Arms (1)

Valbenazine

EXPERIMENTAL

All participants will be treated with Valbenazine for 6 weeks.

Drug: Valbenazine

Interventions

Valbenazine DRUG

All participants will be treated with Valbenazine for 6 weeks.

Valbenazine

Eligibility Criteria

• Age: 26 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 26-84
• Sex: Both males and females will be included
• 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"

You may not qualify if:

• The following classes of patients will be excluded:
• Patients with unstable psychiatric status defined as having a total score on BPRS of 50 or higher
• Patients who have suicidal or homicidal ideation, intent, or plan or viewed as having a significant risk of suicidal or violent behavior;
• Patients with cognitive impairment as defined by a score of 24 or less on the MMSE
• Patients with current diagnosis of alcohol or substance use disorder made according to DSM-5 criteria
• 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.
• Patients previously treated with Valbenazine or any other medication specifically indicated for tardive dyskinesia
• Patients currently taking strong CYP3A4 inducers, dopamine agonists, MAO inhibitors, stimulants, and/or VMAT2 inhibitors
• Patients with congenital long QT syndrome or arrhythmias associated with prolonged QT interval
• 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
• Patients tested positive for Coronavirus Covid-19
• Patients with impaired decision-making capacity
• Institutionalized individuals
• Prisoners

Sponsors & Collaborators

• Yale University: lead
• Neurocrine Biosciences: collaborator

Study Sites (1)

Yale Church Street Research Unit.

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

Tardive Dyskinesia

Interventions

valbenazine

Condition Hierarchy (Ancestors)

Dyskinesia, Drug-Induced; Dyskinesias; Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• John De Figueiredo, MD

  Clinical Professor of Psychiatry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2021
• First Posted: September 22, 2021
• Study Start: October 18, 2024
• Primary Completion: October 18, 2025
• Study Completion: October 18, 2025
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)