NCT01458340已完成2 期
A Phase 2 Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Proof-of-Concept Study of TD-9855 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 295
- 试验地点
- 17
- 主要终点
- Change From Baseline in AISRS Total Score at Day 42
研究概览
简要总结
The safety and efficacy of multiple dosages of TD-9855, administered once daily, will be evaluated in adult males with ADHD.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must meet the following ADHD diagnostic and inclusion criteria:
- •Subjects must meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for current ADHD subtypes (ADHD combined type, ADHD predominately inattentive type, ADHD predominately hyperactive-impulsive type) as assessed by the clinical interview and confirmed by Adult Attention-Deficit/Hyperactivity Disorder Clinical Diagnostic Scale (ACDS V1.2).
- •Subjects must have a total score of 24 or greater on the AISRS at both the Screening and Baseline Visits AND the Baseline Visit AISRS scores must not vary by more than 20% from Screening.
- •Subjects are required to have CGI-S score ≥4 (moderate) at both the Screening and Baseline Visits. Subjects should have at least moderate severity for ADHD symptoms.
- •For women of childbearing potential, documentation of a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day
- •All female subjects of childbearing potential must be using a highly effective method of birth control during the study and for at least 1 month after completion of study drug dosing.
- •A highly effective method of birth control is defined as one that results in a low failure rate (i.e., <1% per year) when used consistently and correctly, such as condom + diaphragm, condom + spermicide, diaphragm + spermicide, or intrauterine device [IUD] with documented failure rate of <1% per year, or oral/injectable/implanted hormonal contraceptives used in combination with a barrier method.
- •Women are considered to be not of childbearing potential if they have had a total hysterectomy or bilateral tubal ligation (documentation for either must be provided before enrollment) or are at least 2 years postmenopausal. Female subjects cannot be breast-feeding.
排除标准
- •Any current psychiatric disorder other than ADHD as defined in DSM-IV-TR as assessed by Mini International Neuropsychiatric Interview (MINI). Subjects with dysthymia that does not require pharmacological treatment will not be excluded.
- •MADRS total score >
- •A diagnosis of ADHD NOS.
- •Any diagnosis of lifetime bipolar disorder or psychotic disorder
- •A current diagnosis of any severe comorbid Axis II disorder
- •Any history of mental retardation, organic mental disorders due to general medical condition or pervasive developmental disorder as defined by DSM-IV-TR.-
研究组 & 干预措施
Placebo
Experimental
干预措施: Placebo (Drug)
TD-9855 Dose 2
Experimental
干预措施: TD-9855 (Drug)
TD-9855 Dose 1
Experimental
干预措施: TD-9855 (Drug)
结局指标
主要结局
Change From Baseline in AISRS Total Score at Day 42
时间窗: Baseline and Day 42
The AISRS is a modified version of the ADHD Rating Scale that more accurately reflects the impact and severity of ADHD among adults. It is a clinician-administered scale that measures all 18 symptoms of adult ADHD using a Likert scale from 0 (not present) to 3 (severe). The total score ranges from 0 to 54 with a negative change from baseline indicating an improvement in severity/reduction in symptoms.
次要结局
- Change From Baseline in BDEFS-SF Symptom Count at Day 42(Baseline and Day 42)
- Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Score at Day 42(Baseline and Day 42)
- Change From Baseline in Adult ADHD Self-Report Scale (ASRS) Total Score at Day 42(Baseline and Day 42)
- Change From Baseline in ASRS Hyperactive-impulsive Subscale at Day 42(Baseline and Day 42)
- Change From Baseline in BDEFS-SF: Self Report Total Score at Day 42(Baseline and Day 42)
- Change From Baseline in AISRS Inattentive Subscale at Day 42(Baseline and Day 42)
- Change From Baseline in AISRS Hyperactive-impulsive Subscale at Day 42(Baseline and Day 42)
- Change From Baseline in ASRS Inattentive Subscale at Day 42(Baseline and Day 42)
- Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Day 42(Baseline and Day 42)
- Percentage of Participants With an AISRS Response at Day 42(Day 42)
- Percentage of Participants With a Reliable Change on the BDEFS-SF at Day 42(Baseline and Day 42)
- Percentage of Participants With a Reliable Change and Normalized Score on the BDEFS-SF at Day 42(Baseline and Day 42)
研究者
研究点 (17)
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