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

Обзор

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.

Вмешательства

• Препарат Methylphenidate Hydrochloride Extended Release Capsule
  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).

Первичные конечные точки

• Change in Expanded Adult ADHD Investigator Symptom Rating Scale (AISRS) Score from Baseline to Week 3 [Срок оценки: Baseline, Week 3]
• Change in Expanded Adult ADHD Investigator Symptom Rating Scale (AISRS) Score from Baseline to Week 10 [Срок оценки: Baseline, Week 10]

Вторичные конечные точки (12)

• Change in Expanded AISRS - Overall Inattentive (IA) Subscale Score [Срок оценки: Baseline, Week 3]
• Change in Expanded AISRS - Overall Inattentive (IA) Subscale Score [Срок оценки: Baseline, Week 10]
• Change in Expanded AISRS - Hyperactive/Impulsive (HI) Subscale Score [Срок оценки: Baseline, Week 3]
• Change in Expanded AISRS - Hyperactive/Impulsive (HI) Subscale Score [Срок оценки: Baseline, Week 10]
• Change from Baseline in Clinical Global Impression-Severity (CGI-S) Scale Score [Срок оценки: Baseline, Week 3]
• Change from Baseline in Clinical Global Impression-Severity (CGI-S) Scale Score [Срок оценки: Baseline, Week 10]
• 11-Hours Post-Dose Time-Sensitive ADHD Symptom Scale (TASS) Score at Visit 3 [Срок оценки: Week 3 (11-hours Post-Dose)]
• 11-Hours Post-Dose TASS Score at Visit 4 [Срок оценки: Week 4 (11-hours Post-Dose)]
• 11-Hours Post-Dose TASS Score at Visit 5 [Срок оценки: Week 5 (11-hours Post-Dose)]
• 11-Hours Post-Dose TASS Score at Visit 6 [Срок оценки: Week 6 (11-hours Post-Dose)]
• 11-Hours Post-Dose TASS Score at Visit 7 [Срок оценки: Week 7 (11-hours Post-Dose)]
• 11-Hours Post-Dose TASS Score at Visit 8 [Срок оценки: Week 8 (11-hours Post-Dose)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• NYU Langone Health — New York

Идентификаторы

NCT: NCT06577779 · 19-01325

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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