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NCT Number: NCT06577779

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

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.

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Key information

Conditions

Attention-Deficit/Hyperactivity Disorder Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

NYU Langone Health

New York, 10016, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Methylphenidate Hydrochloride Extended Release Capsule

Drug

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: Jornay PM

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Change in Expanded AISRS - Overall Inattentive (IA) Subscale Score

    Time frame: Baseline, Week 3

    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.

  2. Change in Expanded AISRS - Overall Inattentive (IA) Subscale Score

    Time frame: Baseline, Week 10

    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.

  3. Change in Expanded AISRS - Hyperactive/Impulsive (HI) Subscale Score

    Time frame: Baseline, Week 3

    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.

  4. Change in Expanded AISRS - Hyperactive/Impulsive (HI) Subscale Score

    Time frame: Baseline, Week 10

    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.

  5. Change from Baseline in Clinical Global Impression-Severity (CGI-S) Scale Score

    Time frame: Baseline, Week 3

    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.

  6. Change from Baseline in Clinical Global Impression-Severity (CGI-S) Scale Score

    Time frame: Baseline, Week 10

    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.

  7. 11-Hours Post-Dose Time-Sensitive ADHD Symptom Scale (TASS) Score at Visit 3

    Time frame: Week 3 (11-hours Post-Dose)

    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.

  8. 11-Hours Post-Dose TASS Score at Visit 4

    Time frame: Week 4 (11-hours Post-Dose)

    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.

  9. 11-Hours Post-Dose TASS Score at Visit 5

    Time frame: Week 5 (11-hours Post-Dose)

    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.

  10. 11-Hours Post-Dose TASS Score at Visit 6

    Time frame: Week 6 (11-hours Post-Dose)

    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.

  11. 11-Hours Post-Dose TASS Score at Visit 7

    Time frame: Week 7 (11-hours Post-Dose)

    18-item assessment of ADHD symptoms. Each item is rated on a 4-point Likert scale from 0 (not at all) to 3 (severe). The total score is the sum of responses and ranges from 0 to 54; higher scores indicate greater severity of symptoms.

  12. 11-Hours Post-Dose TASS Score at Visit 8

    Time frame: Week 8 (11-hours Post-Dose)

    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.

  13. 11-Hours Post-Dose TASS Score at Visit 9

    Time frame: Week 9 (11-hours Post-Dose)

    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.

  14. 11-Hours Post-Dose TASS Score at Visit 10

    Time frame: Week 10 (11-hours Post-Dose)

    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.

  15. 16-Hours Post-Dose TASS Score at Visit 3

    Time frame: Week 3 (16-hours Post-Dose)

    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.

  16. 16-Hours Post-Dose TASS Score at Visit 4

    Time frame: Week 4 (16-hours Post-Dose)

    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.

  17. 16-Hours Post-Dose TASS Score at Visit 5

    Time frame: Week 5 (16-hours Post-Dose)

    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.

  18. 16-Hours Post-Dose TASS Score at Visit 6

    Time frame: Week 6 (16-hours Post-Dose)

    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.

  19. 16-Hours Post-Dose TASS Score at Visit 7

    Time frame: Week 7 (16-hours Post-Dose)

    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.

  20. 16-Hours Post-Dose TASS Score at Visit 8

    Time frame: Week 8 (16-hours Post-Dose)

    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.

  21. 16-Hours Post-Dose TASS Score at Visit 9

    Time frame: Week 9 (16-hours Post-Dose)

    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.

  22. 16-Hours Post-Dose TASS Score at Visit 10

    Time frame: Week 10 (16-hours Post-Dose)

    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.

  23. 21-Hours Post-Dose TASS Score at Visit 3

    Time frame: Week 3 (21-hours Post-Dose)

    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.

  24. 21-Hours Post-Dose TASS Score at Visit 4

    Time frame: Week 4 (21-hours Post-Dose)

    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.

  25. 21-Hours Post-Dose TASS Score at Visit 5

    Time frame: Week 5 (21-hours Post-Dose)

    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.

  26. 21-Hours Post-Dose TASS Score at Visit 6

    Time frame: Week 6 (21-hours Post-Dose)

    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.

  27. 21-Hours Post-Dose TASS Score at Visit 7

    Time frame: Week 7 (21-hours Post-Dose)

    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.

  28. 21-Hours Post-Dose TASS Score at Visit 8

    Time frame: Week 8 (21-hours Post-Dose)

    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.

  29. 21-Hours Post-Dose TASS Score at Visit 9

    Time frame: Week 9 (21-hours Post-Dose)

    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.

  30. 21-Hours Post-Dose TASS Score at Visit 10

    Time frame: Week 10 (21-hours Post-Dose)

    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.

  31. 24-Hours Post-Dose TASS Score at Visit 3

    Time frame: Week 3 (24-hours Post-Dose)

    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.

  32. 24-Hours Post-Dose TASS Score at Visit 4

    Time frame: Week 4 (24-hours Post-Dose)

    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.

  33. 24-Hours Post-Dose TASS Score at Visit 5

    Time frame: Week 5 (24-hours Post-Dose)

    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.

  34. 24-Hours Post-Dose TASS Score at Visit 6

    Time frame: Week 6 (24-hours Post-Dose)

    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.

  35. 24-Hours Post-Dose TASS Score at Visit 7

    Time frame: Week 7 (24-hours Post-Dose)

    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.

  36. 24-Hours Post-Dose TASS Score at Visit 8

    Time frame: Week 8 (24-hours Post-Dose)

    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.

  37. 24-Hours Post-Dose TASS Score at Visit 9

    Time frame: Week 9 (24-hours Post-Dose)

    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.

  38. 24-Hours Post-Dose TASS Score at Visit 10

    Time frame: Week 10 (24-hours Post-Dose)

    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.

  39. 11-Hours Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 3

    Time frame: Week 3 (11-hours Post-Dose)

    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.

  40. 11-Hours Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 8

    Time frame: Week 8 (11-hours Post-Dose)

    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.

  41. 11-Hours Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 10

    Time frame: Week 10 (11-hours Post-Dose)

    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.

  42. 16-Hours Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 3

    Time frame: Week 3 (16-hours Post-Dose)

    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.

  43. 16-Hours Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 8

    Time frame: Week 8 (16-hours Post-Dose)

    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.

  44. 16-Hours Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 10

    Time frame: Week 10 (16-hours Post-Dose)

    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.

  45. 21-Hours Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 3

    Time frame: Week 3 (21-hours Post-Dose)

    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.

  46. 21-Hours Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 8

    Time frame: Week 8 (21-hours Post-Dose)

    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.

  47. 21-Hours Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 10

    Time frame: Week 10 (21-hours Post-Dose)

    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.

  48. 24-Hours Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 3

    Time frame: Week 3 (24-hours Post-Dose)

    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.

  49. 24-Hours Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 8

    Time frame: Week 8 (24-hours Post-Dose)

    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.

  50. 24-Hours Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 10

    Time frame: Week 10 (24-hours Post-Dose)

    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.

  51. Change in Adult ADHD Self Report Scale (ASRS) Symptom Checklist Score

    Time frame: Baseline, Week 3

    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.

  52. Change in Adult ADHD Self Report Scale (ASRS) Symptom Checklist Score

    Time frame: Baseline, Week 10

    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.

  53. Change in Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A) Score

    Time frame: Baseline, Week 3

    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).

  54. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Terry Leon, MS, RN

CONTACT

[email protected]

646-754-4841

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 29, 2024
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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