A Phase 1 interventional study of Valbenazine in Tardive Dyskinesia, sponsored by Yale University. Withdrawn at 1 site in United States. Open to participants aged 26 Years to 84 Years. Per ClinicalTrials.gov, last updated 2025-07-11.
Sponsored by Yale University · Phase 1, Interventional, and Treatment
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.
58 studies on the registry are indexed under Tardive Dyskinesia; 9 are open to participants now.
Browse Tardive Dyskinesia studies →Yale University is the lead sponsor of 1,724 studies on the registry; 298 are open to participants now.
Of its 210 completed or terminated interventional studies of FDA-regulated products, 126 (60%) have results posted.
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Exclusion Criteria:
The following classes of patients will be excluded:
All participants will be treated with Valbenazine for 6 weeks.
Drug: Valbenazine
All participants will be treated with Valbenazine for 6 weeks.
Change in demoralization Scale
The change in symptoms of demoralization will be measured using the Demoralization Scale-II (DS-II). Scale scores range from 0 (minimum) to 32 (maximum), with higher scores indicating more demoralization (i.e., a worse outcome). Reduction of score to below 10 will be measured
Time frame: Baseline, week 2, week 4, and week 6
Change in subjective incompetence scale (SIS) score
The SIS consists of 12 items, each item has 4 response alternatives scored as 0, 1, 2, 3. The scores range from 0 to 36. Higher scores mean more severe subjective incompetence.
Time frame: Baseline, week 2, week 4, and week 6
Plan to share: Yes — De-identified data will be shared after a reasonable request and after the project is completed. It will be shared with the sponsor and deposited .
No publications or documents are linked to this record.
This study is withdrawn, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Yale University