MELATONIN & SLEEP STUDIES IN CHILDREN W/ DEVELOPMENTAL DISABILITIES

本研究分为两部分。第一部分将在48小时内通过唾液样本记录大约60名患有脆性X综合征（FXS）的患者（3至21岁）和60名患有精神发育迟滞的对照组（包括Angelman综合征，velocofacial综合征和Smith Magenis综合征）以及正常对照组（包括正常兄弟姐妹）的褪黑素概况。这些患者将从包括墨尔本、里尔、法国、美国国立卫生研究院和丹佛在内的参与中心招募。该研究的第二部分是一个为期三年的项目，旨在评估褪黑素与安慰剂相比，在治疗FXS或其他原因的智力迟钝患者的睡眠障碍方面的疗效。这包括为期两周的基线试验，以及为期四周的褪黑激素或安慰剂治疗，这是第二个四周的交叉期。睡眠日记将用于记录醒来情况，唾液褪黑素水平将每两周测量一次，以记录口服剂量后的依从性和峰值水平。患者将在丹佛和上述其他中心登记。

This study has two parts. The first part will document the melatonin profile by saliva samples in a 48 hour period in approximately 60 patients (aged 3 to 21 years) with fragile X syndrome (FXS) and 60 controls with mental retardation including those with Angelman syndrome, Velocardiofacial syndrome, and Smith Magenis syndrome in addition to normal controls including normal siblings. These patients will be enrolled from participating centers including Melbourne, Lille, France, NIH and Denver. The second part of the study is a three year project to evaluate the efficacy of melatonin compared to placebo in the treatment of sleep disturbances in patients with FXS or other causes of mental retardation. This involves a two week baseline run in with four weeks of treatment with either melatonin or placebo which is crossed over for a second four week period. Sleep diaries will be used to document awakenings and saliva melatonin levels will be measured at two week intervals to document compliance and peak levels after an oral dose. Patients will be enrolled in Denver and other centers noted above.