WITHDRAWN

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-10-18

Study Completion:2025-10-18

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:WITHDRAWN

Study ID

NCT05053321

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:26 Years to 84 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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"	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

Inclusion Criteria

Exclusion 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"

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

Contacts and Locations

Principal Investigator

John De Figueiredo, MD

PRINCIPAL_INVESTIGATOR

Clinical Professor of Psychiatry

Study Locations (Sites)

Yale Church Street Research Unit.

New Haven, Connecticut, 06520

United States

Collaborators and Investigators

Sponsor: Yale University

John De Figueiredo, MD, PRINCIPAL_INVESTIGATOR, Clinical Professor of Psychiatry

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-18

Study Completion Date2025-10-18

Study Record Updates

Study Start Date2024-10-18

Study Completion Date2025-10-18

Terms related to this study

Additional Relevant MeSH Terms

Tardive Dyskinesia