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

Launched by YALE UNIVERSITY · Sep 13, 2021

Keywords

ClinConnect Summary

This clinical trial, titled "Psychological Adjustment to Tardive Dyskinesia," is exploring whether a medication called Valbenazine can help reduce feelings of demoralization in people suffering from tardive dyskinesia. Tardive dyskinesia is a condition that causes involuntary movements and can occur after taking certain psychiatric medications. The goal of this study is to see if it makes sense to conduct a larger study to further investigate this treatment.

To participate, individuals must be between the ages of 26 and 84 and have a diagnosis of tardive dyskinesia caused by the use of neuroleptic medications. However, certain people will not be eligible, such as those with significant psychiatric issues, substance use disorders, or certain medical conditions. Participants can expect to undergo assessments and possibly receive Valbenazine, while contributing to important research that could lead to better treatment options for tardive dyskinesia. The study is currently recruiting participants, so if you or someone you know meets the criteria and is interested, this could be an opportunity to help in the fight against this challenging condition.

Gender

ALL

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