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
Sponsored by
About this trial
This is an interventional treatment trial for Tardive Dyskinesia
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
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
No
Product Manufactured in and Exported from the U.S.
No
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
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 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
No
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
Learn more about this trial
Reduction of Demoralization After Treatment of TD With Valbenazine
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