An Open-Label Treatment With Randomization Observation, Investigator-Initiated Study, on the Duration and Efficacy of Jornay PM (Methylphenidate Hydrochloride Extended-Release Capsules) on Adult ADHD Symptoms and Executive Function and Emotional Regulation Throughout the Day Into Early Evening
NCT Number: NCT06577779
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Attention-deficit/Hyperactivity Disorder
Interventions: DRUG: Methylphenidate Hydrochloride Extended Release Capsule
Sponsor: NYU Langone Health
Sex: ALL
Age: ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-19
Completion Date: 2025-10
Locations: NYU Langone Health, New York, New York, 10016, United States

Summary:
The goal of this study is to extend the efficacy evidence of sustained release methylphenidate compound (JornayPM) in adults with Attention-deficit/hyperactivity disorder (ADHD). JornayPM has recently been approved for treatment of patients 6 years and older with ADHD; the release mechanism is unique among ADHD products in that it is taken in the evening, with effects in the morning upon awakening and then throughout the subsequent day. Of note, to date, there is no clinical data as to the tolerability or clinical effects or dosing in adults with ADHD; therefore the primary aim of this trial is to gather the first set of these data.

Primary Outcome Measures: Change in Expanded Adult ADHD Investigator Symptom Rating Scale (AISRS) Score from Baseline to Week 3, 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., Baseline, Week 3|Change in Expanded Adult ADHD Investigator Symptom Rating Scale (AISRS) Score from Baseline to Week 10, 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., Baseline, Week 10
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., Baseline, Week 3|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., Baseline, Week 10|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., Baseline, Week 3|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., Baseline, Week 10|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., Baseline, Week 3|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., Baseline, Week 10|11-Hours Post-Dose Time-Sensitive ADHD Symptom Scale (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., Week 3 (11-hours Post-Dose)|11-Hours 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., Week 4 (11-hours Post-Dose)|11-Hours 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., Week 5 (11-hours Post-Dose)|11-Hours 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., Week 6 (11-hours Post-Dose)|11-Hours Post-Dose TASS Score at Visit 7, 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., Week 7 (11-hours Post-Dose)|11-Hours Post-Dose TASS Score at Visit 8, 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., Week 8 (11-hours Post-Dose)|11-Hours Post-Dose TASS Score at Visit 9, 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., Week 9 (11-hours Post-Dose)|11-Hours Post-Dose TASS Score at Visit 10, 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., Week 10 (11-hours Post-Dose)|16-Hours 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., Week 3 (16-hours Post-Dose)|16-Hours 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., Week 4 (16-hours Post-Dose)|16-Hours 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., Week 5 (16-hours Post-Dose)|16-Hours 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., Week 6 (16-hours Post-Dose)|16-Hours Post-Dose TASS Score at Visit 7, 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., Week 7 (16-hours Post-Dose)|16-Hours Post-Dose TASS Score at Visit 8, 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., Week 8 (16-hours Post-Dose)|16-Hours Post-Dose TASS Score at Visit 9, 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., Week 9 (16-hours Post-Dose)|16-Hours Post-Dose TASS Score at Visit 10, 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., Week 10 (16-hours Post-Dose)|21-Hours 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., Week 3 (21-hours Post-Dose)|21-Hours 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., Week 4 (21-hours Post-Dose)|21-Hours 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., Week 5 (21-hours Post-Dose)|21-Hours 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., Week 6 (21-hours Post-Dose)|21-Hours Post-Dose TASS Score at Visit 7, 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., Week 7 (21-hours Post-Dose)|21-Hours Post-Dose TASS Score at Visit 8, 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., Week 8 (21-hours Post-Dose)|21-Hours Post-Dose TASS Score at Visit 9, 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., Week 9 (21-hours Post-Dose)|21-Hours Post-Dose TASS Score at Visit 10, 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., Week 10 (21-hours Post-Dose)|24-Hours 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., Week 3 (24-hours Post-Dose)|24-Hours 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., Week 4 (24-hours Post-Dose)|24-Hours 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., Week 5 (24-hours Post-Dose)|24-Hours 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., Week 6 (24-hours Post-Dose)|24-Hours Post-Dose TASS Score at Visit 7, 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., Week 7 (24-hours Post-Dose)|24-Hours Post-Dose TASS Score at Visit 8, 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., Week 8 (24-hours Post-Dose)|24-Hours Post-Dose TASS Score at Visit 9, 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., Week 9 (24-hours Post-Dose)|24-Hours Post-Dose TASS Score at Visit 10, 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., Week 10 (24-hours Post-Dose)|11-Hours 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., Week 3 (11-hours Post-Dose)|11-Hours Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 8, 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., Week 8 (11-hours Post-Dose)|11-Hours Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 10, 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., Week 10 (11-hours Post-Dose)|16-Hours 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., Week 3 (16-hours Post-Dose)|16-Hours Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 8, 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., Week 8 (16-hours Post-Dose)|16-Hours Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 10, 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., Week 10 (16-hours Post-Dose)|21-Hours 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., Week 3 (21-hours Post-Dose)|21-Hours Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 8, 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., Week 8 (21-hours Post-Dose)|21-Hours Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 10, 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., Week 10 (21-hours Post-Dose)|24-Hours 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., Week 3 (24-hours Post-Dose)|24-Hours Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 8, 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., Week 8 (24-hours Post-Dose)|24-Hours Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 10, 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., Week 10 (24-hours Post-Dose)|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., Baseline, Week 3|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., Baseline, Week 10|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)., Baseline, Week 3|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)., Baseline, Week 10