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 range26 Years – 84 Years
SexALL
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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;
✕. 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