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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Subjects will start at dose of 40mg (DR/ER-MPH) day with titrations of 20mg leading to a maximum dose of 100mg (DR/ER-MPH).
NYU Langone Health
New York, New York, United States
RECRUITINGChange 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.
Time frame: 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.
Time frame: Baseline, Week 10
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: Baseline, Week 10
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