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
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Phase 4
Contacts and Locations
Study Contact
Study Contact
- Name: Terry Leon, MS, RN
- Phone Number: 646-754-4841
- Email: Terry.Leon@nyulangone.org
Study Locations
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New York
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New York, New York, United States, 10016
- Recruiting
- NYU Langone Health
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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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 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.
- 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.
Exclusion Criteria:
- 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).
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
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Active Comparator: Seven weeks of Jornay PM treatment
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.
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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).
Other Names:
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Experimental: Five weeks of Jornay PM treatment
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.
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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).
Other Names:
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Expanded Adult ADHD Investigator Symptom Rating Scale (AISRS) Score from Baseline to Week 3
Time Frame: Baseline, Week 3
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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.
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Baseline, Week 3
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Change in Expanded Adult ADHD Investigator Symptom Rating Scale (AISRS) Score from Baseline to Week 10
Time Frame: Baseline, Week 10
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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.
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Baseline, Week 10
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Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Expanded AISRS - Overall Inattentive (IA) Subscale Score
Time Frame: Baseline, Week 3
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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.
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Baseline, Week 3
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Change in Expanded AISRS - Overall Inattentive (IA) Subscale Score
Time Frame: Baseline, Week 10
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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.
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Baseline, Week 10
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Change in Expanded AISRS - Hyperactive/Impulsive (HI) Subscale Score
Time Frame: Baseline, Week 3
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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.
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Baseline, Week 3
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Change in Expanded AISRS - Hyperactive/Impulsive (HI) Subscale Score
Time Frame: Baseline, Week 10
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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.
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Baseline, Week 10
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Change from Baseline in Clinical Global Impression-Severity (CGI-S) Scale Score
Time Frame: Baseline, Week 3
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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.
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Baseline, Week 3
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Change from Baseline in Clinical Global Impression-Severity (CGI-S) Scale Score
Time Frame: Baseline, Week 10
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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.
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Baseline, Week 10
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11-Hours Post-Dose Time-Sensitive ADHD Symptom Scale (TASS) Score at Visit 3
Time Frame: Week 3 (11-hours Post-Dose)
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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.
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Week 3 (11-hours Post-Dose)
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11-Hours Post-Dose TASS Score at Visit 4
Time Frame: Week 4 (11-hours Post-Dose)
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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.
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Week 4 (11-hours Post-Dose)
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11-Hours Post-Dose TASS Score at Visit 5
Time Frame: Week 5 (11-hours Post-Dose)
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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.
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Week 5 (11-hours Post-Dose)
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11-Hours Post-Dose TASS Score at Visit 6
Time Frame: Week 6 (11-hours Post-Dose)
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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.
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Week 6 (11-hours Post-Dose)
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11-Hours Post-Dose TASS Score at Visit 7
Time Frame: Week 7 (11-hours Post-Dose)
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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.
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Week 7 (11-hours Post-Dose)
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11-Hours Post-Dose TASS Score at Visit 8
Time Frame: Week 8 (11-hours Post-Dose)
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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.
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Week 8 (11-hours Post-Dose)
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11-Hours Post-Dose TASS Score at Visit 9
Time Frame: Week 9 (11-hours Post-Dose)
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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.
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Week 9 (11-hours Post-Dose)
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11-Hours Post-Dose TASS Score at Visit 10
Time Frame: Week 10 (11-hours Post-Dose)
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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.
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Week 10 (11-hours Post-Dose)
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16-Hours Post-Dose TASS Score at Visit 3
Time Frame: Week 3 (16-hours Post-Dose)
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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.
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Week 3 (16-hours Post-Dose)
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16-Hours Post-Dose TASS Score at Visit 4
Time Frame: Week 4 (16-hours Post-Dose)
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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.
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Week 4 (16-hours Post-Dose)
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16-Hours Post-Dose TASS Score at Visit 5
Time Frame: Week 5 (16-hours Post-Dose)
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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.
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Week 5 (16-hours Post-Dose)
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16-Hours Post-Dose TASS Score at Visit 6
Time Frame: Week 6 (16-hours Post-Dose)
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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.
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Week 6 (16-hours Post-Dose)
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16-Hours Post-Dose TASS Score at Visit 7
Time Frame: Week 7 (16-hours Post-Dose)
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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.
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Week 7 (16-hours Post-Dose)
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16-Hours Post-Dose TASS Score at Visit 8
Time Frame: Week 8 (16-hours Post-Dose)
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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.
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Week 8 (16-hours Post-Dose)
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16-Hours Post-Dose TASS Score at Visit 9
Time Frame: Week 9 (16-hours Post-Dose)
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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.
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Week 9 (16-hours Post-Dose)
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16-Hours Post-Dose TASS Score at Visit 10
Time Frame: Week 10 (16-hours Post-Dose)
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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.
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Week 10 (16-hours Post-Dose)
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21-Hours Post-Dose TASS Score at Visit 3
Time Frame: Week 3 (21-hours Post-Dose)
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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.
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Week 3 (21-hours Post-Dose)
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21-Hours Post-Dose TASS Score at Visit 4
Time Frame: Week 4 (21-hours Post-Dose)
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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.
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Week 4 (21-hours Post-Dose)
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21-Hours Post-Dose TASS Score at Visit 5
Time Frame: Week 5 (21-hours Post-Dose)
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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.
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Week 5 (21-hours Post-Dose)
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21-Hours Post-Dose TASS Score at Visit 6
Time Frame: Week 6 (21-hours Post-Dose)
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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.
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Week 6 (21-hours Post-Dose)
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21-Hours Post-Dose TASS Score at Visit 7
Time Frame: Week 7 (21-hours Post-Dose)
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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.
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Week 7 (21-hours Post-Dose)
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21-Hours Post-Dose TASS Score at Visit 8
Time Frame: Week 8 (21-hours Post-Dose)
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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.
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Week 8 (21-hours Post-Dose)
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21-Hours Post-Dose TASS Score at Visit 9
Time Frame: Week 9 (21-hours Post-Dose)
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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.
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Week 9 (21-hours Post-Dose)
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21-Hours Post-Dose TASS Score at Visit 10
Time Frame: Week 10 (21-hours Post-Dose)
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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.
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Week 10 (21-hours Post-Dose)
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24-Hours Post-Dose TASS Score at Visit 3
Time Frame: Week 3 (24-hours Post-Dose)
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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.
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Week 3 (24-hours Post-Dose)
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24-Hours Post-Dose TASS Score at Visit 4
Time Frame: Week 4 (24-hours Post-Dose)
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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.
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Week 4 (24-hours Post-Dose)
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24-Hours Post-Dose TASS Score at Visit 5
Time Frame: Week 5 (24-hours Post-Dose)
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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.
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Week 5 (24-hours Post-Dose)
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24-Hours Post-Dose TASS Score at Visit 6
Time Frame: Week 6 (24-hours Post-Dose)
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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.
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Week 6 (24-hours Post-Dose)
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24-Hours Post-Dose TASS Score at Visit 7
Time Frame: Week 7 (24-hours Post-Dose)
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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.
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Week 7 (24-hours Post-Dose)
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24-Hours Post-Dose TASS Score at Visit 8
Time Frame: Week 8 (24-hours Post-Dose)
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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.
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Week 8 (24-hours Post-Dose)
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24-Hours Post-Dose TASS Score at Visit 9
Time Frame: Week 9 (24-hours Post-Dose)
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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.
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Week 9 (24-hours Post-Dose)
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24-Hours Post-Dose TASS Score at Visit 10
Time Frame: Week 10 (24-hours Post-Dose)
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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.
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Week 10 (24-hours Post-Dose)
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11-Hours Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 3
Time Frame: Week 3 (11-hours Post-Dose)
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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.
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Week 3 (11-hours Post-Dose)
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11-Hours Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 8
Time Frame: Week 8 (11-hours Post-Dose)
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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.
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Week 8 (11-hours Post-Dose)
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11-Hours Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 10
Time Frame: Week 10 (11-hours Post-Dose)
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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.
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Week 10 (11-hours Post-Dose)
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16-Hours Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 3
Time Frame: Week 3 (16-hours Post-Dose)
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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.
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Week 3 (16-hours Post-Dose)
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16-Hours Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 8
Time Frame: Week 8 (16-hours Post-Dose)
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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.
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Week 8 (16-hours Post-Dose)
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16-Hours Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 10
Time Frame: Week 10 (16-hours Post-Dose)
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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.
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Week 10 (16-hours Post-Dose)
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21-Hours Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 3
Time Frame: Week 3 (21-hours Post-Dose)
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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.
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Week 3 (21-hours Post-Dose)
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21-Hours Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 8
Time Frame: Week 8 (21-hours Post-Dose)
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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.
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Week 8 (21-hours Post-Dose)
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21-Hours Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 10
Time Frame: Week 10 (21-hours Post-Dose)
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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.
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Week 10 (21-hours Post-Dose)
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24-Hours Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 3
Time Frame: Week 3 (24-hours Post-Dose)
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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.
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Week 3 (24-hours Post-Dose)
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24-Hours Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 8
Time Frame: Week 8 (24-hours Post-Dose)
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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.
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Week 8 (24-hours Post-Dose)
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24-Hours Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 10
Time Frame: Week 10 (24-hours Post-Dose)
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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.
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Week 10 (24-hours Post-Dose)
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Change in Adult ADHD Self Report Scale (ASRS) Symptom Checklist Score
Time Frame: Baseline, Week 3
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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.
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Baseline, Week 3
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Change in Adult ADHD Self Report Scale (ASRS) Symptom Checklist Score
Time Frame: Baseline, Week 10
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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.
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Baseline, Week 10
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Change in Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A) Score
Time Frame: Baseline, Week 3
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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).
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Baseline, Week 3
|
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Change in Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A) Score
Time Frame: Baseline, Week 10
|
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
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Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Lenard Adler, MD, NYU Langone Health
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 19-01325
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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