Reducing demoralization in patients with tardive dyskinesia using Valbenazine
Reduction of Demoralization in Patients With Tardive Dyskinesia After Treatment With Valbenazine
This study is testing if the medication Valbenazine can help reduce feelings of demoralization in people with tardive dyskinesia while also improving their movement symptoms.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 26 Years to 84 Years |
| Sex | All |
| Sponsor | Yale University Academic / other |
| Locations | 1 site (New Haven, Connecticut) |
| Trial ID | NCT05053321 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to evaluate the effects of Valbenazine on reducing demoralization in patients diagnosed with tardive dyskinesia. Participants will undergo assessments measuring demoralization, anxiety, depression, and feelings of incompetence at the start and every two weeks for six weeks following treatment. The study will also assess improvements in tardive dyskinesia symptoms and correlate these with changes in demoralization levels. The goal is to determine if Valbenazine can effectively alleviate both motor symptoms and associated psychological distress.
Who should consider this trial
Good fit: Ideal candidates are adults aged 26-84 diagnosed with tardive dyskinesia induced by dopamine receptor-blocking medications.
Not a fit: Patients with unstable psychiatric conditions, significant cognitive impairment, or current substance use disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from tardive dyskinesia by reducing both motor symptoms and psychological distress.
How similar studies have performed: While there have been studies on tardive dyskinesia treatments, this specific approach using Valbenazine to target demoralization is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
New Haven, Connecticut
- Yale Church Street Research Unit. — New Haven, Connecticut, United States (Recruiting)
Study contacts
- Principal investigator: John De Figueiredo, MD — Clinical Professor of Psychiatry
- Study coordinator: John M de Figueiredo,, MD, ScD
- Email: John.deFigueiredo@yale.edu
- Phone: 203-272-9628
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.