Omega-3 Fatty Acids as an Adjunctive Therapy for Stimulants in Children With ADHD
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Conners Rating Scale for assessment of ADHD characteristics
研究概览
简要总结
Multiple forms of Omega-3 Fatty acids have been used to investigate the role of this food supplement in children with Attention Deficit Hyperactivity Disorder (ADHD). No clear evidence for their role in this disorder is yet available. We will conduct a prospective, randomized, double blind, placebo controlled trial to obtain significant results regarding this question.
详细描述
A total of 30-150 patients or more between the ages of 6 and 15 years old with diagnosis of ADHD according to the DSM-IV and on current treatment with stimulants recruited from CAOS-MMC and the Developmental Center will be evaluated by a child psychiatrist or a resident under supervision of a child psychiatrist to make sure that the diagnosis is correct. Every child will have a Conners rating scale filled out by the parents and teachers on admission to the study. The evaluators will also fill out a Clinical Global Impression scale (CGI).
The patients will be divided in 2 groups. One group of 15 children will be randomized to continue taking the usual dose of stimulants plus placebo (corn oil), which will be given to the patients by MMC's pharmacy.
A second group of 15 patients will be randomized to receive the usual dose of stimulant plus Lovaza (prescription Omega-3 fatty acids) at a dose of 1800 mg daily.
Both groups will be initially treated for a period of 8 weeks. The patients will be re-evaluated by the investigators on week 2, 4, 6 and 8 of the study and on each evaluation the parents and teachers will fill out a Conners rating scale.
The ratings of the Conners rating scales filled for each patient will be analyzed and compared to the initial evaluation after week 8. The evaluators will also do a CGI score for every visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female Children 6 to 15 years old
- •Diagnosis of ADHD according to the DSM IV -TR
排除标准
- •Children younger than 6 y/o or older than 15 y/o
- •Children with other co-morbid disorders according to the DSM IV-TR
- •Mentally retarded children
- •Poor compliance with treatment
- •Children with a diagnosis of blood clotting problems
- •Children on anticoagulants
- •Children with hypersensitivity to fish
- •Children "In care" (CiC): Foster children or children that are not being taken care of by a biological parent or a legal guardian.
- •Children who follow a kosher diet (Lovaza is not kosher)
- •Pregnancy
研究组 & 干预措施
Stimulants plus Lovaza
Usual dose of stimulant plus Lovaza (prescription Omega-3 fatty acids) at a dose of 1800 mg daily.
干预措施: Stimulants plus Lovaza (Dietary Supplement)
Stimulants plus placebo
Usual dose of stimulants plus placebo(corn oil), which will be given to the patients by MMC's pharmacy.
干预措施: Stimulants plus placebo (Drug)
结局指标
主要结局
Conners Rating Scale for assessment of ADHD characteristics
时间窗: 16 WEEKS
Conners Rating Scales is designed to provide an overview of child and adolescent concerns and disorders, including ADHD. The survey for parents contains 80 items and 59 items for teachers. Scoring is based on a response about specific aspects of child behavior, with a low cumulative score showing less likelihood of a specific disorder. The cumulative score is called a T-score. T-scores have a mean of 50 and a standard deviation of 10. These can be converted to percentile scores. T-scores above 60 are cause for concern and have interpretive value. Interpretable scores range from a low T-score of 61 (mildly atypical) to above 70 (markedly atypical).
次要结局
- Clinical Global Impression - Severity Scale (CGI-S)(16 WEEKS)
研究者
Antonios Likourezos
Research Administration Director
Maimonides Medical Center