Reduction of Demoralization After Treatment of TD With Valbenazine

Tardive Dyskinesia Clinical Trial

Official title:

Reduction of Demoralization After Treatment of TD With Valbenazine

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05053321
• Other study ID #: 2000031135
• Secondary ID: No NIH funding
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: April 2024
• Est. completion date: July 2024

Study information

• Verified date: January 2024
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 will be treated with Valbenazine for a total of 7 weeks.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 26 Years to 84 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyskinesias
• Tardive Dyskinesia

Intervention

Drug:
• Valbenazine
All participants will be treated with Valbenazine for 7 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	Neurocrine Biosciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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