MELatonin for children with idiopathic chronic sleep onset insomnia, with or without attention deficit hyperkinesia disorder - a DOSe finding trial: a randomised placebo-controlled double-blind parallel group trial

Hospital Pharmacy of the Valley of Gelderland (Ziekenhuisapotheek Gelderse Vallei) (The Netherlands)0 个研究点目标入组 150 人开始时间: 2007年4月13日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•1. At inclusion physical examination, medial history and inclusion/exclusion assessments will be performed. The results of a hypnogram, performed within the past two months, showing a normal sleep architecture has to be known at inclusion
•2. The children and their parents have to be motivated to comply the study protocol

•1. Child-psychiatric or family problems who can explain the sleep onset insomnia
•2. Disturbed sleep architecture (hypnogram)
•3. Use of Monoamine Oxidase (MAO) inhibitors
•4. Children with known disturbed hepatic or renal function
•5. Patients with the Roter syndrome
•6. Patients with the Dubin-Johnson syndrome
•7. Factors or diseases which can, according to the investigator, inhibit participation to the study
•8. Medical, environmental, psychiatric or other factors, which can cause sleep onset insomnia during the trial
•9. Participation in a study on the efficacy of drugs in the month preceding the inclusion
•10. Mental retardation (Intelligence Quotient [IQ] less than 80)
•11. Any prior use of melatonin
•12. Use of hypnotics, antidepressants or neuroleptics
•13. Chronic pain
•14. Severe neurological or psychiatric disorder

发起方

Hospital Pharmacy of the Valley of Gelderland (Ziekenhuisapotheek Gelderse Vallei) (The Netherlands)