NCT03945175已完成3 期
Study of the Duration and Efficacy of MYDAYIS on Adult ADHD Symptoms and Executive Function Throughout the Day Into the Early Evening
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Adult ADHD Investigator Symptom Rating Scale (AISRS) Score at End of Placebo Lead-In
研究概览
简要总结
Attention-deficit/hyperactivity disorder (ADHD) is a neuropsychiatric disorder characterized by problems with sustaining attention, organization, planning, procrastination, daydreaming, restlessness, impulsivity and hyperactivity.This is an outpatient study for subjects between the ages of 18-60, who have an Attention deficit hyperactivity disorder (ADHD) diagnosis meeting all inclusion criteria and not meeting any of the exclusion criteria.
详细描述
One purpose of this trial is to extend the evidence basis for Mydayis in adult ADHD to include efficacy with a clinical ADHD symptom measure validated for DSM-5 adult ADHD. Another purpose of this trial is to re-examine the clinical efficacy of Mydayis later in the day on ADHD symptoms; the data on ADHD symptoms via the TASS 1 (Spencer et al. 2008) is a decade old and has not been examined in subsequent trials.
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
- 是
入选标准
- •Male or female between the ages of 18-60 of all races and ethnicity.
- •Meets DSM V-TR criteria for a primary diagnosis of ADHD (including predominantly inattentive presentation, or combined presentation) as diagnosed via the Adult ADHD Clinician Diagnostic Scale version 1.2 (ACDS v1.2)
排除标准
- •Meets DSM V-TR criteria for a primary diagnosis of hyperactive-impulsive type ADHD as diagnosed via the ACDS v1.
- •Any other current psychiatric disorder, determined via the M.I.N.I, which requires pharmacotherapy treatment.
- •Current suicidal ideation or history of suicide attempts, based on the Columbia- Suicide Severity Rating Scale(C-SSRS)
- •Lifetime history of bipolar disorder or any psychotic disorder as per the M.I.N.I
- •Pregnant, breastfeeding or women planning to become pregnant.
- •Positive urine drug toxicology are excluded.
- •Any other reason that, in the opinion of the investigator, prevents the subject from participating in the study or compromise the subject safety.
研究组 & 干预措施
Treatment
Experimental
After a two-week, single-blinded, placebo lead-in, all patients will receive four weeks of order-fixed treatment with Mydayis.
干预措施: MYDAYIS (Drug)
Treatment
Experimental
After a two-week, single-blinded, placebo lead-in, all patients will receive four weeks of order-fixed treatment with Mydayis.
干预措施: Placebo (Drug)
结局指标
主要结局
Adult ADHD Investigator Symptom Rating Scale (AISRS) Score at End of Placebo Lead-In
时间窗: Week 2 (End of Placebo Lead-In)
18-item questionnaire measuring aspects of ADHD in adults. Participants rank items on a 4-point Likert scale: 0 (none), 1 (mild), 2 (moderate), 3 (severe). The total score is the sum of responses and ranges from 0 to 54; higher scores indicate greater severity of ADHD.
Adult ADHD Investigator Symptom Rating Scale (AISRS) Score at End of Mydayis Treatment
时间窗: Week 6 (End of Mydayis Treatment)
18-item questionnaire measuring aspects of ADHD in adults. Participants rank items on a 4-point Likert scale: 0 (none), 1 (mild), 2 (moderate), 3 (severe). The total score is the sum of responses and ranges from 0 to 54; higher scores indicate greater severity of ADHD.
次要结局
- 14-Hour Post-Dose Time-Sensitive Adult ADHD Symptom Scale (TASS) Score at End of Placebo Lead-In(Week 2 (End of Placebo Lead-In))
- WebNeuro Neurocognitive Assessment - Response Speed - Tapping Variability at Baseline(Baseline)
- WebNeuro Neurocognitive Assessment - Response Speed - Tapping Variability at Week 7(Week 7)
- WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Reaction Time at Baseline(Baseline)
- WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Reaction Time at Week 7(Week 7)
- WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Errors (Colors) at Week 7(Week 7)
- WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Reaction Time (Colors) at Baseline(Baseline)
- AISRS: Overall Inattentive (IA) Symptom Subscale Score at End of Mydayis Treatment(Week 6 (End of Mydayis Treatment))
- AISRS: Hyperactive-Impulsive (HI) Symptom Subscale Score at End of Placebo Lead-In(Week 2 (End of Placebo Lead-In))
- AISRS: Hyperactive-Impulsive (HI) Symptom Subscale Score at End of Mydayis Treatment(Week 6 (End of Mydayis Treatment))
- 14-Hour Post-Dose Time-Sensitive Adult ADHD Symptom Scale (TASS) Score at End of Mydayis Treatment(Week 6 (End of Mydayis Treatment))
- Clinical Global Impression-Severity (CGI-S) Scale Score at End of Placebo Lead-In(Week 2 (End of Placebo Lead-In))
- Clinical Global Impression-Severity (CGI-S) Scale Score at End of Mydayis Treatment(Week 6 (End of Mydayis Treatment))
- 14-hour Post-Dose TASS: Inattentive (IA) Symptom Subscale Score at End of Placebo Lead-In(Week 2 (End of Placebo Lead-In))
- 14-hour Post-Dose TASS: Inattentive (IA) Symptom Subscale Score at End of Mydayis Treatment(Week 6 (End of Mydayis Treatment))
- WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Score (Words) at Baseline(Baseline)
- WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Score (Words) at Week 7(Week 7)
- WebNeuro Neurocognitive Assessment - Executive Function - Path Learning Time at Baseline(Baseline)
- WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Errors (Words) at Baseline(Baseline)
- WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Reaction Time (Words) at Baseline(Baseline)
- WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Reaction Time (Words) at Week 7(Week 7)
- WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Score (Colors) at Baseline(Baseline)
- WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Score (Colors) at Week 7(Week 7)
- 14-hour Post-Dose TASS: Hyperactive-Impulsive (HI) Symptom Subscale Score at End of Placebo Lead-In(Week 2 (End of Placebo Lead-In))
- 14-hour Post-Dose TASS: Hyperactive-Impulsive (HI) Symptom Subscale Score at End of Mydayis Treatment(Week 6 (End of Mydayis Treatment))
- WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Errors (Words) at Week 7(Week 7)
- WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Reaction Time (Colors) at Week 7(Week 7)
- WebNeuro Neurocognitive Assessment - Executive Function - Trials Completed at Baseline(Baseline)
- Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) Score at Week 3(Week 3)
- Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) Score at Week 7(Week 7)
- WebNeuro Neurocognitive Assessment - Working Memory Capacity - Recall Span Score at Week 7(Week 7)
- WebNeuro Neurocognitive Assessment - Attention and Concentration - Reaction Time at Week 7(Week 7)
- WebNeuro Neurocognitive Assessment - Working Memory Capacity - Recall Span Score at Baseline(Baseline)
- WebNeuro Neurocognitive Assessment - Executive Function - Trials Completed at Week 7(Week 7)
- AISRS: Overall Inattentive (IA) Symptom Subscale Score at End of Placebo Lead-In(Week 2 (End of Placebo Lead-In))
- WebNeuro Neurocognitive Assessment - Working Memory Capacity - Working Memory Accuracy at Baseline(Baseline)
- WebNeuro Neurocognitive Assessment - Working Memory Capacity - Working Memory Accuracy at Week 7(Week 7)
- WebNeuro Neurocognitive Assessment - Attention and Concentration - False Alarms at Baseline(Baseline)
- WebNeuro Neurocognitive Assessment - Attention and Concentration - False Alarms at Week 7(Week 7)
- WebNeuro Neurocognitive Assessment - Executive Function - Completion Time at Baseline(Baseline)
- WebNeuro Neurocognitive Assessment - Attention and Concentration - Reaction Time at Baseline(Baseline)
- WebNeuro Neurocognitive Assessment - Attention and Concentration - False Misses at Baseline(Baseline)
- WebNeuro Neurocognitive Assessment - Attention and Concentration - False Misses at Week 7(Week 7)
- WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Completion Time at Baseline(Baseline)
- WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Completion Time at Week 7(Week 7)
- WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Average Connection Time at Baseline(Baseline)
- WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Average Connection Time at Week 7(Week 7)
- WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Errors (Colors) at Baseline(Baseline)
- WebNeuro Neurocognitive Assessment - Executive Function - Completion Time at Week 7(Week 7)
- WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Errors at Baseline(Baseline)
- WebNeuro Neurocognitive Assessment - Information Processing Efficiency - Errors at Week 7(Week 7)
- WebNeuro Neurocognitive Assessment - Response Speed - Number of Taps at Baseline(Baseline)
- WebNeuro Neurocognitive Assessment - Response Speed - Number of Taps at Week 7(Week 7)
- WebNeuro Neurocognitive Assessment - Executive Function - Path Learning Time at Week 7(Week 7)
- WebNeuro Neurocognitive Assessment - Executive Function - Total Errors at Baseline(Baseline)
- WebNeuro Neurocognitive Assessment - Executive Function - Total Errors at Week 7(Week 7)
- WebNeuro Neurocognitive Assessment - Executive Function - Number of Overruns at Baseline(Baseline)
- WebNeuro Neurocognitive Assessment - Executive Function - Number of Overruns at Week 7(Week 7)
- WebNeuro Neurocognitive Assessment - Impulsivity - Reaction Time at Baseline(Baseline)
- WebNeuro Neurocognitive Assessment - Impulsivity - Reaction Time at Week 7(Week 7)
- WebNeuro Neurocognitive Assessment - Impulsivity - False Alarms at Baseline(Baseline)
- WebNeuro Neurocognitive Assessment - Impulsivity - False Alarms at Week 7(Week 7)
- WebNeuro Neurocognitive Assessment - Impulsivity - False Misses at Baseline(Week 7)
- WebNeuro Neurocognitive Assessment - Impulsivity - False Misses at Week 7(Week 7)
研究者
研究点 (1)
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