A Single-Center, Randomized, Double-Blind, Placebo-Controlled Study of The Efficacy and Safety of Phosphatidylserine-Omega3 in Children With Attention-Deficit/ Hyperactivity Disorder
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Conners Rating Scale - School Version
研究概览
简要总结
The primary objective of this trial is to determine whether an oral administration of Phosphatidylserine-Omega3 would significantly improve the clinical symptoms of children suffering from ADHD. Both the behavior and the academic achievements aspects will be evaluated. In addition, we intend to measure side-effects and adverse events and to examine the possible correlation between biochemical and behavioral alterations.
详细描述
This study is a single-center, double-blind, randomized, placebo-controlled 15-weeks duration trial to assess safety and efficacy of Phosphatidylserine-Omega3 in children diagnosed with ADHD, according to the DSM-IV. Following screening, the subjects will be randomized to one of two treatment groups:Phosphatidylserine-Omega3 or placebo, in a 2:1 manner. This will be followed by an open-label extension, in which Phosphatidylserine-Omega3 will be administered to all eligible participants.
Primary measures of attention and behavior will be evaluated using Conners Rating Scale (CRS) teacher- rating scales. As a secondary endpoint, the attention and behavior will be measured by CRS and strength and difficulties questionnaires (SDQ) parental- and SDQ teacher-rating scales, assessment a continuous performance test (TOVA), and parental Child Health questionnaire (CHQ). Improvement in ADHD symptoms will be evaluated by Clinical Global of Impression - Improvement (CGI-I). Finally, tolerability will be monitored using Barkley Side Effects Rating Scale (SERS) and biochemical parameters, such as fatty acid profile and monoamines metabolites will be assessed as well.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parental written informed consent.
- •Having a teacher that is familiar with the child and parent and willing to participate.
- •Age: 13≥ years ≥6
- •Gender: male and female
- •Diagnosis: ADHD diagnosed by:
- •Teacher-rated Attention-Deficit/ Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) School Version at least 1.5 standard deviations (SD) above the norm for the patient's age and gender, Confirmed assessment by Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL),
- •Clinical Global Impression of Severity of illness (CGI-S) rating of 4 or higher (moderately ill or worse),
- •Language: Subjects, parents, and teachers must be able to read, write and speak Hebrew
- •Normal weight and height according to the Israeli standards
- •Attending full-time to school.
排除标准
- •Females who had reached menarche and presented three regular menstrual cycles; the definition of regular menstrual cycles: an average length of the cycle between 22 and 41 days, either none or a single cycle with a length less than 22 or more than 41 days during the past year
- •History or current diagnosis of any serious systemic (e.g., diabetes, hyper/hypothyroidism, etc.) or neurological condition (e.g., epilepsy, brain tumors, etc.)
- •Failed to respond to 2 or more adequate courses (dose and duration) of stimulant therapy for ADHD
- •Pervasive developmental disorder or Non-verbal Learning Disability
- •Schizophrenia, or other psychotic disorders (DSM-IV axis I)
- •Any evidence of suicidal risk, any current psychiatric comorbidity that required psychiatric pharmacotherapy
- •History of alcohol or substance abuse as defined by DSM-IV criteria
- •Consumption of >250 mg/day of caffeine
- •History of allergic reactions or sensitivity to marine products (fish and seafood), soy or corn as well as any illness which may jeopardize the participants health or limit their successful trial completion.
结局指标
主要结局
Conners Rating Scale - School Version
时间窗: change from baseline in conners raiting scale at 15 weeks
A questionnaire that assesses symptoms of ADHD in children and adolescents according to the DSM-IV guidelines. It consists of questions on classroom behavior. Based on the questionnaire results, subscales and global indexes are calculated, including restless-impulsive index, emotional lability index and hyperactive/impulsive subscale. The lowest scale score is 40 (best)and the highest is 90 (worse). Usually, a score below 62 is considered normal and a score above 62 is considered abnormal.
次要结局
- Barkley Side Effects Rating Scale (SERS)(on weeks 0,15)
- Complete Blood Counts(on weeks 0,15)
- Conners Rating Scale - Home Version(change from baseline in conners raiting scale at 15 weeks)
- Strength and Difficulties Questionnaires - School Version(on weeks 0,15)
- Strength and Difficulties Questionnaires - Home Version(on weeks 0,15)
- Clinical Global Impression of Improvement(on weeks 0,15)
- Test of Variables of Attention (TOVA)(on weeks 0,15)
- Child Health Questionnaire (CHQ)- Parent-completed Form 50(on weeks 0,15)
- Plasma and Red Blood Cells Fatty Acid Profile(on weeks 0,15)
- Blood Monoamines Metabolism(on week 0, 15)
- Vital Signs(on weeks 0,15)
- Essential Fatty Acid (EFA)-Deficiency Symptoms(on weeks 0,15)
- Biochemical Parameters in Blood - Liver Functions (SGPT, SGOT, Total Bilirubin), Kidney Functions (BUN, Creatinine), Na, K, Cl, Ca(on weeks 0,15)
- Lipid Profile (Cholesterol, HDL, Triglycerides)(on weeks 0,15)