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WithdrawnNCT05053321Updated Jul 11, 2025

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

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 Withdrawn at 1 site in United States.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

Why this study was withdrawn
Lack of funding.
Phase
Phase 1
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
26 Years to 84 Years
Sex
All
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Study 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.

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Conditions studied

  • Tardive Dyskinesia

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03

In context

Tardive Dyskinesia

58 studies on the registry are indexed under Tardive Dyskinesia; 9 are open to participants now.

Browse Tardive Dyskinesia studies →

Lead sponsor

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.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
26 Years to 84 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Valbenazine

    All participants will be treated with Valbenazine for 6 weeks.

    Drug: Valbenazine

Interventions

  • DrugValbenazine

    All participants will be treated with Valbenazine for 6 weeks.

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What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

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Study locations

1 site
  • Yale Church Street Research Unit.
    New Haven, Connecticut 06520, United States
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References and documents

Individual participant data

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.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05053321
Lead sponsor
Yale University
Collaborators
Neurocrine Biosciences
Responsible party
Sponsor
First posted
Sep 22, 2021
Start date
Oct 18, 2024
Primary completion
Oct 18, 2025 (estimated)
Completion
Oct 18, 2025 (estimated)
Last update
Jul 11, 2025

Study contacts

John De Figueiredo, MD
principal investigator · Clinical Professor of Psychiatry

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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