Tardive Dyskinesia
Conditions
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.
Interventions
DRUGValbenazine
All participants will be treated with Valbenazine for 6 weeks.
Sponsors
Neurocrine Biosciences
Yale University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
26 Years to 84 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in demoralization Scale | Baseline, week 2, week 4, and week 6 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in subjective incompetence scale (SIS) score | Baseline, week 2, week 4, and week 6 | 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. |
Countries
United States
Outcome results
None listed