Clinical trial NCT05053321: Reduction of Demoralization in Patients With Tardive Dyskinesia After Treatment With Valbenazine
Official title: Reduction of Demoralization in Patients With Tardive Dyskinesia After Treatment With Valbenazine
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Tardive Dyskinesia
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Neurocrine Biosciences
First posted: 2021-09-22
Enrollment: 15
Sex: ALL
Minimum age (years): 26
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in demoralization Scale
timeFrame: Baseline, week 2, week 4, and week 6
Secondary outcomes:
measure: Change in subjective incompetence scale (SIS) score
timeFrame: Baseline, week 2, week 4, and week 6
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Church Street Research Unit.
state: Connecticut
Study officials:
affiliation: Clinical Professor of Psychiatry
name: John De Figueiredo, MD
role: PRINCIPAL_INVESTIGATOR
References: