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Reduction of Demoralization After Treatment of TD With Valbenazine

Primary Purpose

Tardive Dyskinesia

Status

Not yet recruiting

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

Valbenazine

About this trial

This is an interventional treatment trial for Tardive Dyskinesia

Eligibility Criteria

26 Years - 84 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Valbenazine

Arm Description

All participants will be treated with Valbenazine for 7 weeks.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT05053321

First Posted

September 13, 2021

Last Updated

August 4, 2023

Sponsor

Yale University

Collaborators

Neurocrine Biosciences

1. Study Identification

Unique Protocol Identification Number

NCT05053321

Brief Title

Reduction of Demoralization After Treatment of TD With Valbenazine

Official Title

Reduction of Demoralization After Treatment of TD With Valbenazine

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

September 2023 (Anticipated)

Primary Completion Date

January 2024 (Anticipated)

Study Completion Date

January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yale University

Collaborators

Neurocrine Biosciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this research project is to determine the feasibility of a larger study aimed at demonstrating that treatment of tardive dyskinesia with Valbenazine is associated with reduction of demoralization

Detailed Description

This will be an Investigator-initiated, prospective, single center, interventional pilot study. This study will examine the feasibility of a larger study aimed at determining if there is an association between the improvement in tardive dyskinesia and the reduction in demoralization and subjective incompetence in patients with tardive dyskinesia after treatment with Valbenazine. Participants will be treated with Valbenazine for a total of 7 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tardive Dyskinesia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Valbenazine

Arm Type

Experimental

Arm Description

All participants will be treated with Valbenazine for 7 weeks.

Intervention Type

Drug

Intervention Name(s)

Valbenazine

Intervention Description

All participants will be treated with Valbenazine for 7 weeks.

Primary Outcome Measure Information:

Title

Change in demoralization Scale

Description

Time Frame

Baseline, week 2, week 4, and week 6

Secondary Outcome Measure Information:

Title

Change in subjective incompetence scale (SIS) score

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

26 Years

Maximum Age & Unit of Time

84 Years

Accepts Healthy Volunteers

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

12. IPD Sharing Statement

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Reduction of Demoralization After Treatment of TD With Valbenazine

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