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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
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

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:

  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:

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

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

    First Posted
    September 13, 2021
    Last Updated
    August 4, 2023
    Sponsor
    Yale University
    Collaborators
    Neurocrine Biosciences
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    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

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    Reduction of Demoralization After Treatment of TD With Valbenazine

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