Tardive DyskinesiaPhase 1NCT05053321
Reduction of Demoralization in Patients With Tardive Dyskinesia After Treatment With Valbenazine
A Phase 1 study testing Valbenazine in people with Tardive Dyskinesia, run by Yale University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 26 to 84 years
- Conditions the study is for
- Tardive Dyskinesia
- What is being tested?
- Valbenazine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Oct 2024to 18 Oct 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 26 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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"
Who cannot join
- The following classes of patients will be excluded:
- 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.
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- 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
- Patients with congenital long QT syndrome or arrhythmias associated with prolonged QT interval
- 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
- Patients tested positive for Coronavirus Covid-19
- Patients with impaired decision-making capacity
- Institutionalized individuals
- Prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale Church Street Research Unit.
New Haven, Connecticut, 06520
About this study
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.
- Conditions
- Tardive Dyskinesia
- Being tested
- Valbenazine
- Medical subject headings
- Tardive Dyskinesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ValbenazineDrug
All participants will be treated with Valbenazine for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Valbenazine | Experimental | All participants will be treated with Valbenazine for 6 weeks. Receives: Drug: Valbenazine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Baseline, week 2, week 4, and week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2021
- Study start18 Oct 2024
- Primary completion18 Oct 2025 (estimated)
- Study completion18 Oct 2025 (estimated)
Why it stopped: Lack of funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tardive DyskinesiaStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Neurocrine Biosciences
- Responsible party
- Sponsor
- Investigators
- John De Figueiredo, MD, Principal investigator, Clinical Professor of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05053321
- Sponsor's protocol ID
- 2000031423
- Other IDs
- No NIH funding
- Status last verified
- Jul 2025
- First submitted
- 13 Sep 2021
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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 .
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Demoralization in Patients With Tardive Dyskinesia After Treatment With Valbenazine
- ClinicalTrials.gov ID
- NCT05053321
- Acronym / sponsor ID
- 2000031423
- Conditions
- Tardive Dyskinesia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Neurocrine Biosciences
- Study start
- 18 Oct 2024 (actual)
- Primary completion
- 18 Oct 2025 (estimated)
- Study completion
- 18 Oct 2025 (estimated)
- First posted
- 22 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Valbenazine | Experimental | Drug: ValbenazineAll participants will be treated with Valbenazine for 6 weeks. |
Who may qualify
- Ages
- 26 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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"
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ValbenazineAll participants will be treated with Valbenazine for 6 weeks. | Drug | Valbenazine |
Primary outcome
Change in demoralization Scale
Time frame: Baseline, week 2, week 4, and week 6
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
1 secondary outcome
Change in subjective incompetence scale (SIS) score
Time frame: Baseline, week 2, week 4, and week 6
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
- Individual participant dataSharing planned: 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 .
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John De Figueiredo, MD principal investigator
Clinical Professor of Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Valbenazine in people with Tardive Dyskinesia, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in demoralization Scale (time frame: Baseline, week 2, week 4, and week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2025.