NCT02257216已完成不适用
A Randomized, Sequential Parallel, Double-Blind, Placebo- Controlled Medical Food Study for the Safety and Efficacy of Vayarin® in Adults With Attention Deficit Hyperactivity Disorder (ADHD)
Enzymotec6 个研究点 分布在 1 个国家目标入组 171 人开始时间: 2014年10月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 171
- 试验地点
- 6
- 主要终点
- Adult ADHD Investigator Symptom Rating Scale (AISRS) total score
研究概览
简要总结
The primary study objective is to evaluate the efficacy of Vayarin in ADHD adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Male and female age 18-60 inclusive.
- •Primary diagnosis of ADHD
- •At least 50% of the sample will have an abnormal score on the Emotional Control subscale of the BRIEF-A of ≥
- •AISRS total score ≥ 24
- •CGI-S ≥4 (moderately ill or worse).
- •Subjects in ongoing psychotherapy will be allowed, but no significant changes in the frequency, type or intensity of the therapy are to be made during the course of their study participation per the discretion of the principal investigator. The subject must be in psychotherapy at least 4 weeks prior to the screening visit.
- •Understands and is able, willing, and likely to fully comply with the study procedures and restrictions.
- •Has given written informed consent to participate in the study.
排除标准
- •BMI less than18.5 or greater than
- •Any underlying/ history or current diagnosis of systemic and/or metabolic disease (e.g. diabetes, Crohn's disease) and/or neurological condition state that may render the subject illegible to participate in the study as assessed by medical history, physical exam, clinical and lab evaluation.
- •History of uncontrolled hypertension or a resting systolic blood pressure > 140mmHg or diastolic blood pressure > 90mmHg (Subjects with well controlled hypertension on a stable dose (2 months) of anti-hypertensives will be allowed to participate).
- •Hamilton Anxiety Scale (HAM-A) ≥ 17).
- •Hamilton Depression scale (HAM-D ≥ 13).
- •Major depression or anxiety disorder which is a focus of treatment or requires taking medication.
- •A lifetime history of psychosis or bipolar disorder based on a clinician-administered interview using the Mini International Neuropsychiatric Interview (M.I.N.I 7.0). Subjects with mild to moderate forms of social phobia and dysthymia, not requiring treatment, will be allowed.
- •Has any concurrent chronic or unstable medical condition that could confound with the results of safety assessments, increase risk to the subject or lead to difficulty complying with the protocol.
- •Subjects taking any medication with CNS effects (excluding subjects who discontinue the medications at least 2 weeks prior to the study for stimulants and 4 weeks for SSRI, non-stimulants, and alpha 2-agonist).
- •Subjects with a history of two or more prior failed adequate trials of ADHD treatment due to adverse events.
- •Use of dietary supplements with potential CNS effect, including omega-3 supplements, 30 days before study initiation and throughout the study.
- •Clinical history of cognitive impairment in judgment of investigator.
- •Pregnant or breast-feeding subjects. Women of childbearing potential must have a negative pregnancy test performed at screening visit prior to randomization. Women of childbearing potential must agree to use adequate birth control for the entire duration of the study.
- •Subjects with a current (within the last 3 months) DSM-V diagnosis of alcohol or drug abuse or dependence (excluding nicotine).
- •Known history of allergic reactions or sensitivity to marine products (fish and seafood), or soy.
- •Has taken an investigational drug or taken part in a clinical trial within 30 days prior to screening.
- •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
Sequence 2: Placebo/Treatment
Active Comparator
Placebo/Treatment- consists of Placebo for 8 weeks followed by 8 weeks of treatment with Vayarin®
干预措施: Vayarin® (Other)
Sequence 2: Placebo/Treatment
Active Comparator
Placebo/Treatment- consists of Placebo for 8 weeks followed by 8 weeks of treatment with Vayarin®
干预措施: Placebo (Other)
Sequence 1: Treatment/Treatment
Active Comparator
Treatment/Treatment- consists of Vayarin® for 8 weeks followed by 8 weeks of additional treatment with Vayarin®
干预措施: Vayarin® (Other)
Sequence 3: Placebo/Placebo
Placebo Comparator
Placebo/Placebo- consists of Placebo for 8 weeks followed by 8 weeks of additional treatment with Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Adult ADHD Investigator Symptom Rating Scale (AISRS) total score
时间窗: over 16 weeks
次要结局
- Clinician Global Impression improvement (CGI-I)(over 16 weeks)
- AISRS(over 16 weeks)
- Behavior Rating Inventory of Executive Function for adults (BRIEF-A)(over 16 weeks)
- Adult ADHD Self-Report Scale (ASRS)(over 16 weeks)
- Clinician Global Impression-Severity (CGI-S)(over 16 weeks)
- Adult ADHD Quality of Life Measure (AAQoL)(over 16 weeks)
- Pittsburgh Sleep Quality Index (PSQI)(over 16 weeks)
- Adverse events monitoring(over 16 weeks)
研究者
研究点 (6)
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