Attention-deficit/Hyperactivity DisorderPhase 4NCT06577779
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
A Phase 4 study testing Methylphenidate Hydrochloride Extended Release Capsule in people with Attention-deficit/Hyperactivity Disorder, run by NYU Langone Health at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Attention-deficit/Hyperactivity Disorder
- What is being tested?
- Methylphenidate Hydrochloride Extended Release Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jan 2025to 30 Oct 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults ages 18-60 years, inclusive at the time of consent
- Able to provide signed informed consent
- Any gender
- Subjects with a current primary Diagnostic and Statistical Manual of Mental Disorders (DSM) -5 diagnosis of ADHD of predominantly inattentive presentation, or combined presentations) as confirmed by the Adult ADHD Clinical Diagnostic Scale (ACDS) Version 1.2.
- Subjects who are not receiving any pharmacological treatment for ADHD must have an DSM AISRS 18 item total score of ≥ 28 at screening. Subjects who were previously receiving pharmacological treatment for ADHD at screening must have a minimum total DSM AISRS 18 item 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.
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- Subjects, who have not used stimulant medication in the past 2 months.
- Occasional use of marijuana (less than 3 times weekly) will be allowed during screening process until subject is enrolled into the study. After subject is enrolled onto Jornay PM, subject is asked to complete an attestation. The attestation will state that the subject will not consume marijuana while in the study.
- No illicit substance will be allowed at screening or during the study.
Who cannot join
- Known hypersensitivity to 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 International Neuropsychiatric Interview (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 (except for marijuana use of less than three times a week and/or history of excessive marijuana use of less than three times a week within 6 months).
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- 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
- Antidepressants and anti-anxiety agents (including benzodiazepines) taken in stable doses will be allowed, while other psychotropic medications, including hallucinogens, mood stabilizers, antipsychotics will not be allowed
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
NYU Langone Health
New York, New York, 10016
About this study
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.
- Conditions
- Attention-deficit/Hyperactivity Disorder
- Being tested
- Methylphenidate Hydrochloride Extended Release Capsule
- Keywords
- ADHD, Adult ADHD
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylphenidate Hydrochloride Extended Release CapsuleDrug
Also called Jornay PM
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).
| Study group | Role | What they receive |
|---|---|---|
| Seven weeks of Jornay PM treatment | Active comparator | Enrolled participants will begin with a two-week observation stabilization before starting treatment with Jornay PM. 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 initiate a 7 week open-label treatment with Jornay PM. Receives: Drug: Methylphenidate Hydrochloride Extended Release Capsule |
| Five weeks of Jornay PM treatment | Experimental | Enrolled participants will begin with a two-week observation stabilization before starting treatment with Jornay PM. 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 initiate a 5 week open-label treatment with Jornay PM followed by a two week observation period; not receiving Jornay PM. Receives: Drug: Methylphenidate Hydrochloride Extended Release Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, Week 10
Secondary outcomes (54)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: Baseline, Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start29 Jan 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention-deficit/Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lenard Adler, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06577779
- Sponsor's protocol ID
- 19-01325
- Status last verified
- Apr 2026
- First submitted
- 28 Aug 2024
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: The summary data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Terry.Leon@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06577779
- Acronym / sponsor ID
- 19-01325
- Conditions
- Attention-deficit/Hyperactivity Disorder
- Keywords
- ADHD, Adult ADHD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 29 Jan 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 29 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Seven weeks of Jornay PM treatment | Active comparator | Drug: Methylphenidate Hydrochloride Extended Release CapsuleEnrolled participants will begin with a two-week observation stabilization before starting treatment with Jornay PM. 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 initiate a 7 week open-label treatment with Jornay PM. |
| Five weeks of Jornay PM treatment | Experimental | Drug: Methylphenidate Hydrochloride Extended Release CapsuleEnrolled participants will begin with a two-week observation stabilization before starting treatment with Jornay PM. 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 initiate a 5 week open-label treatment with Jornay PM followed by a two week observation period; not receiving Jornay PM. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Adults ages 18-60 years, inclusive at the time of consent
- Able to provide signed informed consent
- Any gender
- Subjects with a current primary Diagnostic and Statistical Manual of Mental Disorders (DSM) -5 diagnosis of ADHD of predominantly inattentive presentation, or combined presentations) as confirmed by the Adult ADHD Clinical Diagnostic Scale (ACDS) Version 1.2.
- Subjects who are not receiving any pharmacological treatment for ADHD must have an DSM AISRS 18 item total score of ≥ 28 at screening. Subjects who were previously receiving pharmacological treatment for ADHD at screening must have a minimum total DSM AISRS 18 item score of ≥ 22 at screening
Key exclusion criteria (13 listed)
- Known hypersensitivity to 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 International Neuropsychiatric Interview (MINI) (i.e., a focus of clinical attention or a cause of substantial social or occupational difficulty)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methylphenidate Hydrochloride Extended Release CapsuleAlso: Jornay PMSubjects will start at dose of 40mg (DR/ER-MPH) day with titrations of 20mg leading to a maximum dose of 100mg (DR/ER-MPH). | Drug | Five weeks of Jornay PM treatment, Seven weeks of Jornay PM treatment |
Primary outcome
Change in Expanded Adult ADHD Investigator Symptom Rating Scale (AISRS) Score from Baseline to Week 3
Time frame: Baseline, 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.
Change in Expanded Adult ADHD Investigator Symptom Rating Scale (AISRS) Score from Baseline to Week 10
Time frame: Baseline, 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.
54 secondary outcomes
Change in Expanded AISRS - Overall Inattentive (IA) Subscale Score
Time frame: Baseline, Week 3
Change in Expanded AISRS - Overall Inattentive (IA) Subscale Score
Time frame: Baseline, Week 10
Change in Expanded AISRS - Hyperactive/Impulsive (HI) Subscale Score
Time frame: Baseline, Week 3
Change in Expanded AISRS - Hyperactive/Impulsive (HI) Subscale Score
Time frame: Baseline, Week 10
Change from Baseline in Clinical Global Impression-Severity (CGI-S) Scale Score
Time frame: Baseline, Week 3
Change from Baseline in Clinical Global Impression-Severity (CGI-S) Scale Score
Time frame: Baseline, Week 10
11-Hours Post-Dose Time-Sensitive ADHD Symptom Scale (TASS) Score at Visit 3
Time frame: Week 3 (11-hours Post-Dose)
11-Hours Post-Dose TASS Score at Visit 4
Time frame: Week 4 (11-hours Post-Dose)
11-Hours Post-Dose TASS Score at Visit 5
Time frame: Week 5 (11-hours Post-Dose)
11-Hours Post-Dose TASS Score at Visit 6
Time frame: Week 6 (11-hours Post-Dose)
11-Hours Post-Dose TASS Score at Visit 7
Time frame: Week 7 (11-hours Post-Dose)
11-Hours Post-Dose TASS Score at Visit 8
Time frame: Week 8 (11-hours Post-Dose)
11-Hours Post-Dose TASS Score at Visit 9
Time frame: Week 9 (11-hours Post-Dose)
11-Hours Post-Dose TASS Score at Visit 10
Time frame: Week 10 (11-hours Post-Dose)
16-Hours Post-Dose TASS Score at Visit 3
Time frame: Week 3 (16-hours Post-Dose)
16-Hours Post-Dose TASS Score at Visit 4
Time frame: Week 4 (16-hours Post-Dose)
16-Hours Post-Dose TASS Score at Visit 5
Time frame: Week 5 (16-hours Post-Dose)
16-Hours Post-Dose TASS Score at Visit 6
Time frame: Week 6 (16-hours Post-Dose)
16-Hours Post-Dose TASS Score at Visit 7
Time frame: Week 7 (16-hours Post-Dose)
16-Hours Post-Dose TASS Score at Visit 8
Time frame: Week 8 (16-hours Post-Dose)
16-Hours Post-Dose TASS Score at Visit 9
Time frame: Week 9 (16-hours Post-Dose)
16-Hours Post-Dose TASS Score at Visit 10
Time frame: Week 10 (16-hours Post-Dose)
21-Hours Post-Dose TASS Score at Visit 3
Time frame: Week 3 (21-hours Post-Dose)
21-Hours Post-Dose TASS Score at Visit 4
Time frame: Week 4 (21-hours Post-Dose)
21-Hours Post-Dose TASS Score at Visit 5
Time frame: Week 5 (21-hours Post-Dose)
21-Hours Post-Dose TASS Score at Visit 6
Time frame: Week 6 (21-hours Post-Dose)
21-Hours Post-Dose TASS Score at Visit 7
Time frame: Week 7 (21-hours Post-Dose)
21-Hours Post-Dose TASS Score at Visit 8
Time frame: Week 8 (21-hours Post-Dose)
21-Hours Post-Dose TASS Score at Visit 9
Time frame: Week 9 (21-hours Post-Dose)
21-Hours Post-Dose TASS Score at Visit 10
Time frame: Week 10 (21-hours Post-Dose)
24-Hours Post-Dose TASS Score at Visit 3
Time frame: Week 3 (24-hours Post-Dose)
24-Hours Post-Dose TASS Score at Visit 4
Time frame: Week 4 (24-hours Post-Dose)
24-Hours Post-Dose TASS Score at Visit 5
Time frame: Week 5 (24-hours Post-Dose)
24-Hours Post-Dose TASS Score at Visit 6
Time frame: Week 6 (24-hours Post-Dose)
24-Hours Post-Dose TASS Score at Visit 7
Time frame: Week 7 (24-hours Post-Dose)
24-Hours Post-Dose TASS Score at Visit 8
Time frame: Week 8 (24-hours Post-Dose)
24-Hours Post-Dose TASS Score at Visit 9
Time frame: Week 9 (24-hours Post-Dose)
24-Hours Post-Dose TASS Score at Visit 10
Time frame: Week 10 (24-hours Post-Dose)
11-Hours Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 3
Time frame: Week 3 (11-hours Post-Dose)
11-Hours Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 8
Time frame: Week 8 (11-hours Post-Dose)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No. The summary data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Terry.Leon@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lenard Adler, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methylphenidate Hydrochloride Extended Release Capsule in people with Attention-deficit/Hyperactivity Disorder, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Terry Leon, MS, RN (646-754-4841, Terry.Leon@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Expanded Adult ADHD Investigator Symptom Rating Scale (AISRS) Score from Baseline to Week 3 (time frame: Baseline, Week 3). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.