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

NCT ID: NCT05053321

Last Updated: 2025-07-11

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-18
• Study Completion Date: 2025-10-18

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Valbenazine

All participants will be treated with Valbenazine for 6 weeks.

Group Type: EXPERIMENTAL

Valbenazine

Intervention Type: DRUG

All participants will be treated with Valbenazine for 6 weeks.

Interventions

Valbenazine

All participants will be treated with Valbenazine for 6 weeks.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 26 Years
• Maximum Eligible Age: 84 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Neurocrine Biosciences

INDUSTRY

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John De Figueiredo, MD

Role: PRINCIPAL_INVESTIGATOR

Clinical Professor of Psychiatry

Locations

Yale Church Street Research Unit.

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

No NIH funding

Identifier Type: OTHER

Identifier Source: secondary_id

2000031423

Identifier Type: -

Identifier Source: org_study_id