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
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Expanded Adult ADHD Investigator Symptom Rating Scale (AISRS) Score from Baseline to Week 3
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults ages 18-60 years, inclusive at the time of consent
- •Able to provide signed informed consent
- •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.
- •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.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Methylphenidate Hydrochloride Extended Release Capsule (Drug)
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.
干预措施: Methylphenidate Hydrochloride Extended Release Capsule (Drug)
结局指标
主要结局
Change in Expanded Adult ADHD Investigator Symptom Rating Scale (AISRS) Score from Baseline to Week 3
时间窗: 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
时间窗: 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.
次要结局
- Change in Expanded AISRS - Overall Inattentive (IA) Subscale Score(Baseline, Week 10)
- Change in Expanded AISRS - Hyperactive/Impulsive (HI) Subscale Score(Baseline, Week 10)
- 16-Hours Post-Dose TASS Score at Visit 4(Week 4 (16-hours Post-Dose))
- 16-Hours Post-Dose TASS Score at Visit 5(Week 5 (16-hours Post-Dose))
- 16-Hours Post-Dose TASS Score at Visit 8(Week 8 (16-hours Post-Dose))
- 21-Hours Post-Dose TASS Score at Visit 4(Week 4 (21-hours Post-Dose))
- 11-Hours Post-Dose Time-Sensitive ADHD Symptom Scale (TASS) Score at Visit 3(Week 3 (11-hours Post-Dose))
- 11-Hours Post-Dose TASS Score at Visit 4(Week 4 (11-hours Post-Dose))
- 11-Hours Post-Dose TASS Score at Visit 8(Week 8 (11-hours Post-Dose))
- Change from Baseline in Clinical Global Impression-Severity (CGI-S) Scale Score(Baseline, Week 10)
- 11-Hours Post-Dose TASS Score at Visit 7(Week 7 (11-hours Post-Dose))
- 11-Hours Post-Dose TASS Score at Visit 10(Week 10 (11-hours Post-Dose))
- 16-Hours Post-Dose TASS Score at Visit 7(Week 7 (16-hours Post-Dose))
- 21-Hours Post-Dose TASS Score at Visit 7(Week 7 (21-hours Post-Dose))
- 11-Hours Post-Dose TASS Score at Visit 5(Week 5 (11-hours Post-Dose))
- 11-Hours Post-Dose TASS Score at Visit 6(Week 6 (11-hours Post-Dose))
- 11-Hours Post-Dose TASS Score at Visit 9(Week 9 (11-hours Post-Dose))
- 16-Hours Post-Dose TASS Score at Visit 6(Week 6 (16-hours Post-Dose))
- 16-Hours Post-Dose TASS Score at Visit 3(Week 3 (16-hours Post-Dose))
- 21-Hours Post-Dose TASS Score at Visit 5(Week 5 (21-hours Post-Dose))
- 21-Hours Post-Dose TASS Score at Visit 6(Week 6 (21-hours Post-Dose))
- 24-Hours Post-Dose TASS Score at Visit 6(Week 6 (24-hours Post-Dose))
- 11-Hours Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 3(Week 3 (11-hours Post-Dose))
- 16-Hours Post-Dose TASS Score at Visit 9(Week 9 (16-hours Post-Dose))
- 16-Hours Post-Dose TASS Score at Visit 10(Week 10 (16-hours Post-Dose))
- 21-Hours Post-Dose TASS Score at Visit 8(Week 8 (21-hours Post-Dose))
- 21-Hours Post-Dose TASS Score at Visit 10(Week 10 (21-hours Post-Dose))
- 24-Hours Post-Dose TASS Score at Visit 4(Week 4 (24-hours Post-Dose))
- 11-Hours Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 8(Week 8 (11-hours Post-Dose))
- 16-Hours Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 8(Week 8 (16-hours Post-Dose))
- 16-Hours Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 10(Week 10 (16-hours Post-Dose))
- 21-Hours Post-Dose TASS Score at Visit 3(Week 3 (21-hours Post-Dose))
- 21-Hours Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 8(Week 8 (21-hours Post-Dose))
- 24-Hours Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 3(Week 3 (24-hours Post-Dose))
- Change in Adult ADHD Self Report Scale (ASRS) Symptom Checklist Score(Baseline, Week 10)
- Change in Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A) Score(Baseline, Week 10)
- 21-Hours Post-Dose TASS Score at Visit 9(Week 9 (21-hours Post-Dose))
- 24-Hours Post-Dose TASS Score at Visit 5(Week 5 (24-hours Post-Dose))
- 24-Hours Post-Dose TASS Score at Visit 8(Week 8 (24-hours Post-Dose))
- 11-Hours Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 10(Week 10 (11-hours Post-Dose))
- 16-Hours Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 3(Week 3 (16-hours Post-Dose))
- 24-Hours Post-Dose TASS Score at Visit 3(Week 3 (24-hours Post-Dose))
- 24-Hours Post-Dose TASS Score at Visit 7(Week 7 (24-hours Post-Dose))
- 24-Hours Post-Dose TASS Score at Visit 9(Week 9 (24-hours Post-Dose))
- 24-Hours Post-Dose TASS Score at Visit 10(Week 10 (24-hours Post-Dose))
- 24-Hours Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 10(Week 10 (24-hours Post-Dose))
- 21-Hours Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 3(Week 3 (21-hours Post-Dose))
- 21-Hours Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 10(Week 10 (21-hours Post-Dose))
- 24-Hours Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 8(Week 8 (24-hours Post-Dose))