Back to resultsDuration and Efficacy of Azstarys on Adult ADHD Symptoms and Executive Function in Early Evening
Primary Purpose
Adult Attention Deficit Hyperactivity Disorder
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Serdexmethylphenidate/dexmethylphenidate
Sponsored by
About this trial
This is an interventional treatment trial for Adult Attention Deficit Hyperactivity Disorder
Eligibility Criteria
Inclusion Criteria: Adults ages 18-60 years, inclusive at the time of consent Able to provide signed informed consent Any gender Subjects with a current primary DSM-5 diagnosis of ADHD of predominantly inattentive presentation, or combined presentations) as confirmed by the ACDS Version 1.2.5, Subjects who are not receiving any pharmacological treatment for ADHD must have an AISRS 18 item total score of AISRS expanded of ≥ 28 at screening. Subjects who were previously receiving pharmacological treatment for ADHD at screening must have a minimum total AISRS 18 item of AISRS EXPANDED score of ≥ 22 at screening Dysthymia and anxiety disorders in remission but stable on psychiatric medication for three weeks or more at the discretion of principal investigator will be allowed- medication for these disorders to remain constant for the duration of the protocol. Subjects who are stimulant naïve. Exclusion Criteria: Known hypersensitivity to serdexmethylphenidate, methylphenidate, or product components. Concurrent treatment with a monoamine oxidase inhibitor (MAOI), or use of an MAOI within the preceding 14 days. Lifetime bipolar disorder, psychotic disorders, autism, intellectual disability except mood disorders accepted under the inclusion criteria at the discretion of the principal investigator. Active suicidality within past year, or history of suicide attempt in past 2 years Any history of severe past drug dependence determined by the MINI (i.e., a focus of clinical attention or a cause of substantial social or occupational difficulty) Concurrent substance abuse and/or history of substance use within 6 months Use of any prescribed benzodiazepine Any unstable medical or neurological condition; clinically significant medical abnormalities such as cardiovascular abnormalities, and any chronic condition of the central nervous system. Any psychotropic medication usage Known nonresponse to MPH treatment History of allergic reaction or sensitivity to MPH Female of childbearing age, who are breastfeeding, pregnant, planning to be pregnant or men planning to make a woman pregnant during the study or for one-month post study PI/clinician discretion
Sites / Locations
- NYU Langone HealthRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Adult ADHD Patients
Arm Description
Enrolled participants will begin with a two-week observation stabilization before starting treatment with Azstarys. Participants found to have ≥30% change in their total Adult ADHD Investigator Symptom Rating Scale (AISRS) scores during the two-week observation stabilization period treatment will be discontinued from the study. Remaining participants will be dispensed a three-week supply of Azstarys on a weekly basis.
Outcomes
Primary Outcome Measures
Change in Expanded Adult ADHD Investigator Symptom Rating Scale (AISRS) Score from Baseline to Week 2
The expanded AISRS is an 18-item questionnaire assessing symptoms of adult ADHD. Items are ranked on a 4-point Likert scale ranging from 0 (none) to 3 (severe). The total score is the sum of responses and ranges from 0 to 54; higher scores indicate more severe symptoms of ADHD.
Change in Expanded AISRS Score from Baseline to Week 5
The expanded AISRS is an 18-item questionnaire assessing symptoms of adult ADHD. Items are ranked on a 4-point Likert scale ranging from 0 (none) to 3 (severe). The total score is the sum of responses and ranges from 0 to 54; higher scores indicate more severe symptoms of ADHD.
Secondary Outcome Measures
Change in Expanded AISRS - Overall Inattentive (IA) Subscale Score
9-item subscale of the AISRS assessing inattentive symptoms of ADHD. Items are ranked on a 4-point Likert scale ranging from 0 (none) to 3 (severe). The total score is the sum of responses and ranges from 0 to 27; higher scores indicate greater overall inattentive symptoms.
Change in Expanded AISRS - Overall Inattentive (IA) Subscale Score
9-item subscale of the AISRS assessing inattentive symptoms of ADHD. Items are ranked on a 4-point Likert scale ranging from 0 (none) to 3 (severe). The total score is the sum of responses and ranges from 0 to 27; higher scores indicate greater overall inattentive symptoms.
Change in Expanded AISRS - Hyperactive/Impulsive (HI) Subscale Score
9-item subscale of the AISRS assessing hyperactive/impulsive symptoms of ADHD. Items are ranked on a 4-point Likert scale ranging from 0 (none) to 3 (severe). The total score is the sum of responses and ranges from 0 to 27; higher scores indicate greater hyperactive/impulsive symptoms.
Change in Expanded AISRS - Hyperactive/Impulsive (HI) Subscale Score
9-item subscale of the AISRS assessing hyperactive/impulsive symptoms of ADHD. Items are ranked on a 4-point Likert scale ranging from 0 (none) to 3 (severe). The total score is the sum of responses and ranges from 0 to 27; higher scores indicate greater hyperactive/impulsive symptoms.
1-Hour Post-Dose TASS Score at Visit 3
18-item assessment of ADHD symptoms. Each item is rated on a 4-point Likert scale from 0 (not at all) to 3 (severe). The total score is the sum of responses and ranges from 0 to 54; higher scores indicate greater severity of symptoms.
1-Hour Post-Dose TASS Score at Visit 4
18-item assessment of ADHD symptoms. Each item is rated on a 4-point Likert scale from 0 (not at all) to 3 (severe). The total score is the sum of responses and ranges from 0 to 54; higher scores indicate greater severity of symptoms.
1-Hour Post-Dose TASS Score at Visit 5
18-item assessment of ADHD symptoms. Each item is rated on a 4-point Likert scale from 0 (not at all) to 3 (severe). The total score is the sum of responses and ranges from 0 to 54; higher scores indicate greater severity of symptoms.
1-Hour Post-Dose TASS Score at Visit 6
18-item assessment of ADHD symptoms. Each item is rated on a 4-point Likert scale from 0 (not at all) to 3 (severe). The total score is the sum of responses and ranges from 0 to 54; higher scores indicate greater severity of symptoms.
4-Hour Post-Dose TASS Score at Visit 3
18-item assessment of ADHD symptoms. Each item is rated on a 4-point Likert scale from 0 (not at all) to 3 (severe). The total score is the sum of responses and ranges from 0 to 54; higher scores indicate greater severity of symptoms.
4-Hour Post-Dose TASS Score at Visit 4
18-item assessment of ADHD symptoms. Each item is rated on a 4-point Likert scale from 0 (not at all) to 3 (severe). The total score is the sum of responses and ranges from 0 to 54; higher scores indicate greater severity of symptoms.
4-Hour Post-Dose TASS Score at Visit 5
18-item assessment of ADHD symptoms. Each item is rated on a 4-point Likert scale from 0 (not at all) to 3 (severe). The total score is the sum of responses and ranges from 0 to 54; higher scores indicate greater severity of symptoms.
4-Hour Post-Dose TASS Score at Visit 6
18-item assessment of ADHD symptoms. Each item is rated on a 4-point Likert scale from 0 (not at all) to 3 (severe). The total score is the sum of responses and ranges from 0 to 54; higher scores indicate greater severity of symptoms.
12-Hour Post-Dose TASS Score at Visit 3
18-item assessment of ADHD symptoms. Each item is rated on a 4-point Likert scale from 0 (not at all) to 3 (severe). The total score is the sum of responses and ranges from 0 to 54; higher scores indicate greater severity of symptoms.
12-Hour Post-Dose TASS Score at Visit 4
18-item assessment of ADHD symptoms. Each item is rated on a 4-point Likert scale from 0 (not at all) to 3 (severe). The total score is the sum of responses and ranges from 0 to 54; higher scores indicate greater severity of symptoms.
12-Hour Post-Dose TASS Score at Visit 5
18-item assessment of ADHD symptoms. Each item is rated on a 4-point Likert scale from 0 (not at all) to 3 (severe). The total score is the sum of responses and ranges from 0 to 54; higher scores indicate greater severity of symptoms.
12-Hour Post-Dose TASS Score at Visit 6
18-item assessment of ADHD symptoms. Each item is rated on a 4-point Likert scale from 0 (not at all) to 3 (severe). The total score is the sum of responses and ranges from 0 to 54; higher scores indicate greater severity of symptoms.
1-Hour Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 3
5-item assessment of the smoothness of effect of ADHD medication throughout the day following dosing. Each item is rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). The total score is the sum of responses and ranges from 0 to 20; higher scores indicate greater smoothness of effect of medication.
1-Hour Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 4
5-item assessment of the smoothness of effect of ADHD medication throughout the day following dosing. Each item is rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). The total score is the sum of responses and ranges from 0 to 20; higher scores indicate greater smoothness of effect of medication.
1-Hour Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 5
5-item assessment of the smoothness of effect of ADHD medication throughout the day following dosing. Each item is rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). The total score is the sum of responses and ranges from 0 to 20; higher scores indicate greater smoothness of effect of medication.
4-Hour Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 3
5-item assessment of the smoothness of effect of ADHD medication throughout the day following dosing. Each item is rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). The total score is the sum of responses and ranges from 0 to 20; higher scores indicate greater smoothness of effect of medication.
4-Hour Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 4
5-item assessment of the smoothness of effect of ADHD medication throughout the day following dosing. Each item is rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). The total score is the sum of responses and ranges from 0 to 20; higher scores indicate greater smoothness of effect of medication.
4-Hour Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 5
5-item assessment of the smoothness of effect of ADHD medication throughout the day following dosing. Each item is rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). The total score is the sum of responses and ranges from 0 to 20; higher scores indicate greater smoothness of effect of medication.
4-Hour Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 6
5-item assessment of the smoothness of effect of ADHD medication throughout the day following dosing. Each item is rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). The total score is the sum of responses and ranges from 0 to 20; higher scores indicate greater smoothness of effect of medication.
12-Hour Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 3
5-item assessment of the smoothness of effect of ADHD medication throughout the day following dosing. Each item is rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). The total score is the sum of responses and ranges from 0 to 20; higher scores indicate greater smoothness of effect of medication.
12-Hour Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 4
5-item assessment of the smoothness of effect of ADHD medication throughout the day following dosing. Each item is rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). The total score is the sum of responses and ranges from 0 to 20; higher scores indicate greater smoothness of effect of medication.
12-Hour Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 5
5-item assessment of the smoothness of effect of ADHD medication throughout the day following dosing. Each item is rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). The total score is the sum of responses and ranges from 0 to 20; higher scores indicate greater smoothness of effect of medication.
12-Hour Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 6
5-item assessment of the smoothness of effect of ADHD medication throughout the day following dosing. Each item is rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). The total score is the sum of responses and ranges from 0 to 20; higher scores indicate greater smoothness of effect of medication.
Change in Adult ADHD Self Report Scale (ASRS) Symptom Checklist Score
The ASRS is a 31-item questionnaire assessing frequency of ADHD symptoms over the previous 7 days. Items are rate on a 5-point Likert scale ranging from 0 (never) to 4 (very often). The total score is the sum of responses and ranges from 0 to 124; higher scores indicate greater frequency of ADHD symptoms.
Change in Adult ADHD Self Report Scale (ASRS) Symptom Checklist Score
The ASRS is a 31-item questionnaire assessing frequency of ADHD symptoms over the previous 7 days. Items are rate on a 5-point Likert scale ranging from 0 (never) to 4 (very often). The total score is the sum of responses and ranges from 0 to 124; higher scores indicate greater frequency of ADHD symptoms.
Change in Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A) Score
The BRIEF-A is a 75-item self-report questionnaire assessing behavioral issues. Items are rated on a 3-point Likert scale: 0 (never), 1 (sometimes), and 2 (often).
Change in Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A) Score
The BRIEF-A is a 75-item self-report questionnaire assessing behavioral issues. Items are rated on a 3-point Likert scale: 0 (never), 1 (sometimes), and 2 (often).
Change from Baseline in Clinical Global Impression-Severity (CGI-S) Scale Score
1-item clinician-rated assessment of the severity of a subject's mental illness. The severity of illness is rated as follows: 0 (not assessed), 1 (normal, not at all ill), 2 (borderline mentally ill), 3 (mildly ill), 4 (moderately ill), 5 (markedly ill), 6 (severely ill), 7 (among the most extremely ill subjects). The total score is the numerical ranking provided by the clinician.
Change from Baseline in Clinical Global Impression-Severity (CGI-S) Scale Score
1-item clinician-rated assessment of the severity of a subject's mental illness. The severity of illness is rated as follows: 0 (not assessed), 1 (normal, not at all ill), 2 (borderline mentally ill), 3 (mildly ill), 4 (moderately ill), 5 (markedly ill), 6 (severely ill), 7 (among the most extremely ill subjects). The total score is the numerical ranking provided by the clinician.
Full Information
NCT ID
NCT06000501
First Posted
August 14, 2023
Last Updated
September 15, 2023
Sponsor
NYU Langone Health
Collaborators
Corium, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT06000501
Brief Title
Duration and Efficacy of Azstarys on Adult ADHD Symptoms and Executive Function in Early Evening
Official Title
An Open-Label Treatment, Investigator-Initiated Study, on the Duration and Efficacy of Azstarys (Serdexmethylphenidate and Dexmethylphenidate) on Adult ADHD Symptoms and Executive Function in Early Evening
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 14, 2023 (Actual)
Primary Completion Date
December 28, 2024 (Anticipated)
Study Completion Date
February 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
Corium, Inc.
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
No
5. Study Description
Brief Summary
One purpose of this trial is to extend the safety and efficacy evidence basis for Azstarys in adults with ADHD. This open-label, treatment study will examine the efficacy of Azstarys on ADHD symptoms using the AISRS 18-item total score on the AISRS-expanded; the Adult ADHD Investigator Symptom Rating Scale. The investigators will also examine Executive Function later in the day (early evening, about 12 hours after first morning dosing).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adult Attention Deficit Hyperactivity Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Adult ADHD Patients
Arm Type
Experimental
Arm Description
Enrolled participants will begin with a two-week observation stabilization before starting treatment with Azstarys. Participants found to have ≥30% change in their total Adult ADHD Investigator Symptom Rating Scale (AISRS) scores during the two-week observation stabilization period treatment will be discontinued from the study. Remaining participants will be dispensed a three-week supply of Azstarys on a weekly basis.
Intervention Type
Drug
Intervention Name(s)
Serdexmethylphenidate/dexmethylphenidate
Other Intervention Name(s)
Azstarys
Intervention Description
Azstarys capsules for once-daily oral use for three weeks. Flexible dose starting at 39.2 mg serd-mph/7.8 mg d-mph and moving up to 52.3 mg serd-mph/10.4 mg d-mph.
Primary Outcome Measure Information:
Title
Change in Expanded Adult ADHD Investigator Symptom Rating Scale (AISRS) Score from Baseline to Week 2
Description
The expanded AISRS is an 18-item questionnaire assessing symptoms of adult ADHD. Items are ranked on a 4-point Likert scale ranging from 0 (none) to 3 (severe). The total score is the sum of responses and ranges from 0 to 54; higher scores indicate more severe symptoms of ADHD.
Time Frame
Baseline, Week 2
Title
Change in Expanded AISRS Score from Baseline to Week 5
Description
The expanded AISRS is an 18-item questionnaire assessing symptoms of adult ADHD. Items are ranked on a 4-point Likert scale ranging from 0 (none) to 3 (severe). The total score is the sum of responses and ranges from 0 to 54; higher scores indicate more severe symptoms of ADHD.
Time Frame
Baseline, Week 5
Secondary Outcome Measure Information:
Title
Change in Expanded AISRS - Overall Inattentive (IA) Subscale Score
Description
9-item subscale of the AISRS assessing inattentive symptoms of ADHD. Items are ranked on a 4-point Likert scale ranging from 0 (none) to 3 (severe). The total score is the sum of responses and ranges from 0 to 27; higher scores indicate greater overall inattentive symptoms.
Time Frame
Baseline, Week 2
Title
Change in Expanded AISRS - Overall Inattentive (IA) Subscale Score
Description
9-item subscale of the AISRS assessing inattentive symptoms of ADHD. Items are ranked on a 4-point Likert scale ranging from 0 (none) to 3 (severe). The total score is the sum of responses and ranges from 0 to 27; higher scores indicate greater overall inattentive symptoms.
Time Frame
Baseline, Week 5
Title
Change in Expanded AISRS - Hyperactive/Impulsive (HI) Subscale Score
Description
9-item subscale of the AISRS assessing hyperactive/impulsive symptoms of ADHD. Items are ranked on a 4-point Likert scale ranging from 0 (none) to 3 (severe). The total score is the sum of responses and ranges from 0 to 27; higher scores indicate greater hyperactive/impulsive symptoms.
Time Frame
Baseline, Week 2
Title
Change in Expanded AISRS - Hyperactive/Impulsive (HI) Subscale Score
Description
9-item subscale of the AISRS assessing hyperactive/impulsive symptoms of ADHD. Items are ranked on a 4-point Likert scale ranging from 0 (none) to 3 (severe). The total score is the sum of responses and ranges from 0 to 27; higher scores indicate greater hyperactive/impulsive symptoms.
Time Frame
Baseline, Week 5
Title
1-Hour Post-Dose TASS Score at Visit 3
Description
18-item assessment of ADHD symptoms. Each item is rated on a 4-point Likert scale from 0 (not at all) to 3 (severe). The total score is the sum of responses and ranges from 0 to 54; higher scores indicate greater severity of symptoms.
Time Frame
Week 2 (1-hour Post-Dose)
Title
1-Hour Post-Dose TASS Score at Visit 4
Description
18-item assessment of ADHD symptoms. Each item is rated on a 4-point Likert scale from 0 (not at all) to 3 (severe). The total score is the sum of responses and ranges from 0 to 54; higher scores indicate greater severity of symptoms.
Time Frame
Week 3 (1-hour Post-Dose)
Title
1-Hour Post-Dose TASS Score at Visit 5
Description
18-item assessment of ADHD symptoms. Each item is rated on a 4-point Likert scale from 0 (not at all) to 3 (severe). The total score is the sum of responses and ranges from 0 to 54; higher scores indicate greater severity of symptoms.
Time Frame
Week 4 (1-hour Post-Dose)
Title
1-Hour Post-Dose TASS Score at Visit 6
Description
18-item assessment of ADHD symptoms. Each item is rated on a 4-point Likert scale from 0 (not at all) to 3 (severe). The total score is the sum of responses and ranges from 0 to 54; higher scores indicate greater severity of symptoms.
Time Frame
Week 5 (1-hour Post-Dose)
Title
4-Hour Post-Dose TASS Score at Visit 3
Description
18-item assessment of ADHD symptoms. Each item is rated on a 4-point Likert scale from 0 (not at all) to 3 (severe). The total score is the sum of responses and ranges from 0 to 54; higher scores indicate greater severity of symptoms.
Time Frame
Week 2 (4-hours Post-Dose)
Title
4-Hour Post-Dose TASS Score at Visit 4
Description
18-item assessment of ADHD symptoms. Each item is rated on a 4-point Likert scale from 0 (not at all) to 3 (severe). The total score is the sum of responses and ranges from 0 to 54; higher scores indicate greater severity of symptoms.
Time Frame
Week 3 (4-hours Post-Dose)
Title
4-Hour Post-Dose TASS Score at Visit 5
Description
18-item assessment of ADHD symptoms. Each item is rated on a 4-point Likert scale from 0 (not at all) to 3 (severe). The total score is the sum of responses and ranges from 0 to 54; higher scores indicate greater severity of symptoms.
Time Frame
Week 4 (4-hours Post-Dose)
Title
4-Hour Post-Dose TASS Score at Visit 6
Description
18-item assessment of ADHD symptoms. Each item is rated on a 4-point Likert scale from 0 (not at all) to 3 (severe). The total score is the sum of responses and ranges from 0 to 54; higher scores indicate greater severity of symptoms.
Time Frame
Week 5 (4-hours Post-Dose)
Title
12-Hour Post-Dose TASS Score at Visit 3
Description
18-item assessment of ADHD symptoms. Each item is rated on a 4-point Likert scale from 0 (not at all) to 3 (severe). The total score is the sum of responses and ranges from 0 to 54; higher scores indicate greater severity of symptoms.
Time Frame
Week 2 (12-hours Post-Dose)
Title
12-Hour Post-Dose TASS Score at Visit 4
Description
18-item assessment of ADHD symptoms. Each item is rated on a 4-point Likert scale from 0 (not at all) to 3 (severe). The total score is the sum of responses and ranges from 0 to 54; higher scores indicate greater severity of symptoms.
Time Frame
Week 3 (12-hours Post-Dose)
Title
12-Hour Post-Dose TASS Score at Visit 5
Description
18-item assessment of ADHD symptoms. Each item is rated on a 4-point Likert scale from 0 (not at all) to 3 (severe). The total score is the sum of responses and ranges from 0 to 54; higher scores indicate greater severity of symptoms.
Time Frame
Week 4 (12-hours Post-Dose)
Title
12-Hour Post-Dose TASS Score at Visit 6
Description
18-item assessment of ADHD symptoms. Each item is rated on a 4-point Likert scale from 0 (not at all) to 3 (severe). The total score is the sum of responses and ranges from 0 to 54; higher scores indicate greater severity of symptoms.
Time Frame
Week 5 (12-hours Post-Dose)
Title
1-Hour Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 3
Description
5-item assessment of the smoothness of effect of ADHD medication throughout the day following dosing. Each item is rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). The total score is the sum of responses and ranges from 0 to 20; higher scores indicate greater smoothness of effect of medication.
Time Frame
Week 2 (1-hour Post-Dose)
Title
1-Hour Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 4
Description
5-item assessment of the smoothness of effect of ADHD medication throughout the day following dosing. Each item is rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). The total score is the sum of responses and ranges from 0 to 20; higher scores indicate greater smoothness of effect of medication.
Time Frame
Week 3 (1-hour Post-Dose)
Title
1-Hour Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 5
Description
5-item assessment of the smoothness of effect of ADHD medication throughout the day following dosing. Each item is rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). The total score is the sum of responses and ranges from 0 to 20; higher scores indicate greater smoothness of effect of medication.
Time Frame
Week 4 (1-hour Post-Dose)
Title
4-Hour Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 3
Description
5-item assessment of the smoothness of effect of ADHD medication throughout the day following dosing. Each item is rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). The total score is the sum of responses and ranges from 0 to 20; higher scores indicate greater smoothness of effect of medication.
Time Frame
Week 2 (1-hour Post-Dose)
Title
4-Hour Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 4
Description
5-item assessment of the smoothness of effect of ADHD medication throughout the day following dosing. Each item is rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). The total score is the sum of responses and ranges from 0 to 20; higher scores indicate greater smoothness of effect of medication.
Time Frame
Week 3 (1-hour Post-Dose)
Title
4-Hour Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 5
Description
5-item assessment of the smoothness of effect of ADHD medication throughout the day following dosing. Each item is rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). The total score is the sum of responses and ranges from 0 to 20; higher scores indicate greater smoothness of effect of medication.
Time Frame
Week 4 (1-hour Post-Dose)
Title
4-Hour Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 6
Description
5-item assessment of the smoothness of effect of ADHD medication throughout the day following dosing. Each item is rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). The total score is the sum of responses and ranges from 0 to 20; higher scores indicate greater smoothness of effect of medication.
Time Frame
Week 5 (1-hour Post-Dose)
Title
12-Hour Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 3
Description
5-item assessment of the smoothness of effect of ADHD medication throughout the day following dosing. Each item is rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). The total score is the sum of responses and ranges from 0 to 20; higher scores indicate greater smoothness of effect of medication.
Time Frame
Week 2 (1-hour Post-Dose)
Title
12-Hour Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 4
Description
5-item assessment of the smoothness of effect of ADHD medication throughout the day following dosing. Each item is rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). The total score is the sum of responses and ranges from 0 to 20; higher scores indicate greater smoothness of effect of medication.
Time Frame
Week 3 (1-hour Post-Dose)
Title
12-Hour Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 5
Description
5-item assessment of the smoothness of effect of ADHD medication throughout the day following dosing. Each item is rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). The total score is the sum of responses and ranges from 0 to 20; higher scores indicate greater smoothness of effect of medication.
Time Frame
Week 4 (1-hour Post-Dose)
Title
12-Hour Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 6
Description
5-item assessment of the smoothness of effect of ADHD medication throughout the day following dosing. Each item is rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). The total score is the sum of responses and ranges from 0 to 20; higher scores indicate greater smoothness of effect of medication.
Time Frame
Week 5 (1-hour Post-Dose)
Title
Change in Adult ADHD Self Report Scale (ASRS) Symptom Checklist Score
Description
The ASRS is a 31-item questionnaire assessing frequency of ADHD symptoms over the previous 7 days. Items are rate on a 5-point Likert scale ranging from 0 (never) to 4 (very often). The total score is the sum of responses and ranges from 0 to 124; higher scores indicate greater frequency of ADHD symptoms.
Time Frame
Baseline, Week 2
Title
Change in Adult ADHD Self Report Scale (ASRS) Symptom Checklist Score
Description
The ASRS is a 31-item questionnaire assessing frequency of ADHD symptoms over the previous 7 days. Items are rate on a 5-point Likert scale ranging from 0 (never) to 4 (very often). The total score is the sum of responses and ranges from 0 to 124; higher scores indicate greater frequency of ADHD symptoms.
Time Frame
Baseline, Week 5
Title
Change in Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A) Score
Description
The BRIEF-A is a 75-item self-report questionnaire assessing behavioral issues. Items are rated on a 3-point Likert scale: 0 (never), 1 (sometimes), and 2 (often).
Time Frame
Baseline, Week 2
Title
Change in Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A) Score
Description
The BRIEF-A is a 75-item self-report questionnaire assessing behavioral issues. Items are rated on a 3-point Likert scale: 0 (never), 1 (sometimes), and 2 (often).
Time Frame
Baseline, Week 5
Title
Change from Baseline in Clinical Global Impression-Severity (CGI-S) Scale Score
Description
1-item clinician-rated assessment of the severity of a subject's mental illness. The severity of illness is rated as follows: 0 (not assessed), 1 (normal, not at all ill), 2 (borderline mentally ill), 3 (mildly ill), 4 (moderately ill), 5 (markedly ill), 6 (severely ill), 7 (among the most extremely ill subjects). The total score is the numerical ranking provided by the clinician.
Time Frame
Baseline, Week 2
Title
Change from Baseline in Clinical Global Impression-Severity (CGI-S) Scale Score
Description
1-item clinician-rated assessment of the severity of a subject's mental illness. The severity of illness is rated as follows: 0 (not assessed), 1 (normal, not at all ill), 2 (borderline mentally ill), 3 (mildly ill), 4 (moderately ill), 5 (markedly ill), 6 (severely ill), 7 (among the most extremely ill subjects). The total score is the numerical ranking provided by the clinician.
Time Frame
Baseline, Week 5
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults ages 18-60 years, inclusive at the time of consent
Able to provide signed informed consent
Any gender
Subjects with a current primary DSM-5 diagnosis of ADHD of predominantly inattentive presentation, or combined presentations) as confirmed by the ACDS Version 1.2.5, Subjects who are not receiving any pharmacological treatment for ADHD must have an AISRS 18 item total score of AISRS expanded of ≥ 28 at screening. Subjects who were previously receiving pharmacological treatment for ADHD at screening must have a minimum total AISRS 18 item of AISRS EXPANDED score of ≥ 22 at screening
Dysthymia and anxiety disorders in remission but stable on psychiatric medication for three weeks or more at the discretion of principal investigator will be allowed- medication for these disorders to remain constant for the duration of the protocol.
Subjects who are stimulant naïve.
Exclusion Criteria:
Known hypersensitivity to serdexmethylphenidate, methylphenidate, or product components.
Concurrent treatment with a monoamine oxidase inhibitor (MAOI), or use of an MAOI within the preceding 14 days.
Lifetime bipolar disorder, psychotic disorders, autism, intellectual disability except mood disorders accepted under the inclusion criteria at the discretion of the principal investigator.
Active suicidality within past year, or history of suicide attempt in past 2 years
Any history of severe past drug dependence determined by the MINI (i.e., a focus of clinical attention or a cause of substantial social or occupational difficulty)
Concurrent substance abuse and/or history of substance use within 6 months
Use of any prescribed benzodiazepine
Any unstable medical or neurological condition; clinically significant medical abnormalities such as cardiovascular abnormalities, and any chronic condition of the central nervous system.
Any psychotropic medication usage
Known nonresponse to MPH treatment
History of allergic reaction or sensitivity to MPH
Female of childbearing age, who are breastfeeding, pregnant, planning to be pregnant or men planning to make a woman pregnant during the study or for one-month post study
PI/clinician discretion
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lenard Adler, MD
Phone
2122633580
Email
Lenard.Adler@nyulangone.org
First Name & Middle Initial & Last Name or Official Title & Degree
Terry Leon, RN
Email
Terry.Leon@nyulangone.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lenard Adler
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The study protocol, statistical analysis plan, outcome measure results and adverse event data will be made available on ClinicalTrials.gov. IPD will not be shared due to capacity constraints and privacy concerns.
Learn more about this trial
Duration and Efficacy of Azstarys on Adult ADHD Symptoms and Executive Function in Early Evening
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