Reduction of Demoralization in Patients With Tardive Dysk... | NCT05053321

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

NCT05053321

Sponsor

Yale University

Status

Withdrawn

Last Update Posted

Jul 11, 2025Actual

Enrollment

0Actual

Phase

Phase 1

Conditions

Tardive Dyskinesia

Interventions

Valbenazine

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
No NIH funding	Other Identifier	11.09.23

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Lack of funding.

Expanded Access Info

Start Date

Oct 18, 2024Actual

Primary Completion Date

Oct 18, 2025Estimated

Completion Date

Oct 18, 2025Estimated

First Submitted Date

Sep 13, 2021

First Submission Date that Met QC Criteria

Sep 13, 2021

First Posted Date

Sep 22, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 9, 2025

Last Update Posted Date

Jul 11, 2025Actual

Name	Class
Neurocrine Biosciences	INDUSTRY

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Label	Type	Description	Intervention Names
Valbenazine	Experimental	All participants will be treated with Valbenazine for 6 weeks.	Drug: Valbenazine

Name	Type	Description	Arm Group Labels	Other Names
Valbenazine	Drug	All participants will be treated with Valbenazine for 6 weeks.	Valbenazine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	Baseline, week 2, week 4, and week 6

Secondary Outcomes

Measure	Description	Time Frame
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.	Baseline, week 2, week 4, and week 6

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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:

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.
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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

26 Years

Maximum Age

84 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
John De Figueiredo, MD	Clinical Professor of Psychiatry	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Yale Church Street Research Unit.		New Haven	Connecticut	06520	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

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 .

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D004409	Dyskinesia, Drug-Induced
D020820	Dyskinesias
D009069	Movement Disorders
D002493	Central Nervous System Diseases