NCT06000501已完成4 期
An Open-Label Treatment, Investigator-Initiated Study, on the Duration and Efficacy of Azstarys (Serdexmethylphenidate and Dexmethylphenidate) on Adult ADHD Symptoms and Executive Function in Early Evening
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Change in Expanded Adult ADHD Investigator Symptom Rating Scale (AISRS) Total Score
研究概览
简要总结
This is a single-site study. One purpose of this trial is to extend the safety and efficacy evidence basis for Azstarys in adults with ADHD. This open-label, treatment study will examine the efficacy of Azstarys on ADHD symptoms using the AISRS 18-item total score on the AISRS-expanded; the Adult ADHD Investigator Symptom Rating Scale. The investigators will also examine Executive Function later in the day (early evening, about 12 hours after first morning dosing).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Any gender
- •Subjects with a current primary DSM-5 diagnosis of ADHD of predominantly inattentive presentation, or combined presentations) as confirmed by the Adult ADHD Clinical Diagnostic Scale (ACDS) Version 1.2.5, Subjects who are not receiving any pharmacological treatment for ADHD must have an AISRS 18 item total score of AISRS expanded of ≥ 28 at screening. Subjects who were previously receiving pharmacological treatment for ADHD at screening must have a minimum total AISRS 18 item of AISRS EXPANDED 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 are stimulant naïve.
排除标准
- •Known hypersensitivity to serdexmethylphenidate, 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 (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
- •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.
- •Any psychotropic medication usage
- •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
Adult ADHD Patients
Experimental
Enrolled participants will begin with a two-week observation stabilization before starting treatment with Azstarys. 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 be dispensed a three-week supply of Azstarys on a weekly basis.
干预措施: Serdexmethylphenidate/dexmethylphenidate (Drug)
结局指标
主要结局
Change in Expanded Adult ADHD Investigator Symptom Rating Scale (AISRS) Total Score
时间窗: Week 2, Week 5
The expanded AISRS is an 34-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 102; higher scores indicate more severe symptoms of ADHD.
次要结局
- Change in Expanded AISRS - Overall Inattentive (IA) Subscale Score(Week 2, Week 5)
- Change in Expanded AISRS - Hyperactive/Impulsive (HI) Subscale Score(Week 2, Week 5)
- Change in Expanded AISRS - Overall Executive Dysfunction (EFD) Subscale Score(Week 2, Week 5)
- Change in Expanded AISRS - Overall Emotional Control (EC) Subscale Score(Week 2, Week 5)
- Change in Adult ADHD Self Report Scale (ASRS) Symptom Checklist DSM-5 Expanded Score(Week 2, Week 5)
- Change in Adult ADHD Self Report Scale (ASRS) Symptom Checklist Hyperactive (HI) Subscale Score(Week 2, Week 5)
- Change in Adult ADHD Self Report Scale (ASRS) Symptom Checklist Executive Dysfunction (EFD) Subscale Score(Week 2, Week 5)
- Adult ADHD Medication Smoothness of Effect Scale (AMSES) - 8-Hour Post Dose Score(Week 5)
- Change in Adult ADHD Self Report Scale (ASRS) Symptom Checklist Inattentive (IA) Subscale Score(Week 2, Week 5)
- Change in Adult ADHD Self Report Scale (ASRS) Symptom Checklist Score Overall Emotional Dyscontrol (ED) Subscale Score(Week 2, Week 5)
- Change in 4-Hour Post-Dose TASS Score(Week 2, Week 5)
- Change in 1-Hour Post-Dose Time-Sensitive ADHD Symptom Scale (TASS) Score(Week 2, Week 5)
- Adult ADHD Medication Smoothness of Effect Scale (AMSES) - 6-Hour Post Dose Score(Week 5)
- Adult ADHD Medication Smoothness of Effect Scale (AMSES) - 10-Hour Post Dose Score(Week 5)
- Change in 12-Hour Post-Dose TASS Score(Week 2, Week 5)
- Adult ADHD Medication Smoothness of Effect Scale (AMSES) - 4-Hour Post Dose Score(Week 5)
- Adult ADHD Medication Smoothness of Effect Scale (AMSES) - 12-Hour Post Dose Score(Week 5)
- AMSES - Overall Smoothness of Effect Scale Score(Week 5)
- Change in Behavioral Regulation Index (BRI) T-Score(Week 2, Week 5)
- Change in Metacognition Index (MI) T-Score(Week 2, Week 5)
- Change in Global Executive Composite (GEC) T-score(Week 2, Week 5)
- Change in Clinical Global Impression-Severity (CGI-S) Scale Score(Week 2, Week 5)
研究者
研究点 (1)
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