Reduction of Demoralization in Patients With Tardive Dyskinesia After Treatment With Valbenazine (NCT05053321) | Clinical Trial Compass
WithdrawnPhase 1
Reduction of Demoralization in Patients With Tardive Dyskinesia After Treatment With Valbenazine
Stopped: Lack of funding.
United States0Started 2024-10-18
Plain-language 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.
Who can participate
Age range
26 Years – 84 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age: 26-84
. Sex: Both males and females will be included
. 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
. Patients with unstable psychiatric status defined as having a total score on BPRS of 50 or higher
. Patients who have suicidal or homicidal ideation, intent, or plan or viewed as having a significant risk of suicidal or violent behavior;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Patients with cognitive impairment as defined by a score of 24 or less on the MMSE
. Patients with current diagnosis of alcohol or substance use disorder made according to DSM-5 criteria
. 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.
. Patients previously treated with Valbenazine or any other medication specifically indicated for tardive dyskinesia
. Patients currently taking strong CYP3A4 inducers, dopamine agonists, MAO inhibitors, stimulants, and/or VMAT2 inhibitors
. Patients with congenital long QT syndrome or arrhythmias associated with prolonged QT interval