NCT01777048终止3 期
Augmenting the Effects of Methylphenidate: A Randomized, Placebo-Controlled Trial of Omega-3 Fatty Acids Supplementation in Children With Attention Deficit Hyperactivity Disorder
University Hospital, Basel, Switzerland2 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2013年4月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Change in ADHD Rating Scale-IV total score
研究概览
简要总结
The overarching aim of the proposed study is to assess whether omega-3 fatty acids supplementation can augment the effects of methylphenidate in children with ADHD. The investigators hypothesized that omega-3 fatty acids supplementation will be associated with improved ADHD symptoms.
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 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants between ages 6 and 12 years who:
- •have been clinically diagnosed with ADHD by a physician
- •meet the criteria of ADHD-Inattention, ADHD-Hyperactivity-Impulsivity, or ADHD-Combined type as determined by the SNAP-IV (Swanson, 1992)
- •are willing to participate in a randomized, double-blind, placebo-controlled trial, complete with written, informed parental consent,
- •are on stable dosage of methylphenidate treatment before the start of the study
- •are able to speak English or German
排除标准
- •Participants who are younger than 6 years old or older than 12 years old
- •Those who have not been clinically diagnosed with ADHD by a physician
- •Those who did not meet the criteria of ADHD-Inattention, ADHD-Hyperactivity-Impulsivity, or ADHD-Combined type as determined by the SNAP-IV (Swanson, 1992)
- •Those without written parental consent
- •Those with brain pathology such as serious head injury, epilepsy, and intellectual disability (IQ < 70)
- •Those with titrated dosage of methylphenidate before the start of the study
- •Those on neurofeedback training, and/or psychosocial intervention addressing attention problems
- •Those with known hypersensitivity to the IMP under investigation
- •Those who are unable to read and understand the parent/participant information
- •Those receiving medications other than methylphenidate
结局指标
主要结局
Change in ADHD Rating Scale-IV total score
时间窗: Baseline, Week 6, and Week 12
次要结局
- Change in Child Behaviour Checklist total score(Baseline and Week 12)
研究者
Yoon Phaik Ooi
Researcher
University Hospital, Basel, Switzerland
研究点 (2)
Loading locations...
相似试验
撤回
不适用
The Effect of Omega-3 Fatty Acid Supplementation on Intraocular Pressure & Ocular SurfaceOpen Angle GlaucomaOcular HypertensionNCT02295358University of Colorado, Denver
已完成
2 期
Omega-3 Fatty Acid Supplementation to ADHD Pharmacotherapy in ADHD Adults With Deficient Emotional Self-Regulation TraitsAttention Deficit Hyperactivity Disorder (ADHD)Deficient Emotional Self-Regulation (DESR)NCT01399827Massachusetts General Hospital2
已完成
2 期
Cytidine and Omega-3 Fatty Acids in Bipolar DisorderBipolar DisorderNCT00854737Mclean Hospital90
Unknown
2 期
Study to Assess the Effect of Intravenous Supplementation of Omega-3 Fatty Acids on Outcome of Recipients in Living Donor Liver TransplantationLiver TransplantationNCT04030065Institute of Liver and Biliary Sciences, India124
已完成
不适用
Essential Fatty Acids for Major DepressionMajor DepressionNCT00256412University of Iowa24