Evaliuation of the effect of Melatonin and Agomelatin on sleep problem in children and adolescent with Autism spactrum disorder

Evaluation effect of Agomelatine on sleep disorders in children and adolescents with ASD and comparing the results with Melatonin.

Pts 3-18 with ASD and CSHQscore above 41: the intervention group:Agomelatin 25 mg HS, control group:Melatonin 3 ml for 3-6 1/2 tab and for 6-12 and one tab and for 12-18, 5 mg tab (1)HS, half hour before bed. study is a double blind clinical trial. Randomization in the form of permuted block randomization in blocks based on the sample size in sizes 2, 4, 6, 8 with a ratio of 1:1 in one or two groups, until the sample size is exhausted using the website https://icostatistics.shinyapps.io/ randlist/ will do.Sample size: Taking into the total sleep time,based on the reference, that before the treatment was 449 minutes and after the treatment was 532 minutes, with a standard deviation of 121, a power of 80% and an error of 5%, two groups of 35 pt plus 5, to avoid falling into each group

Pt in psychiatric clinics (3-18 ys old) in Imam Hossein Hospital with autism and sleep dis selecet and after informed consent,complete demographic questionnaire,CSHQ (scores above 41),GARS (for autism severity) and KSADS (for R/O comorbid disorder) so treatment starts for1month. At the end of1month CSHQ will be complete. parents,patient and psychiatrist that completing questionnaires (in both groups) will be blinded, and drugs will be delivered by clinic secretary, under hygienic conditions,in an anonymous and same packages.

CSHQ scor above 41 without sleep apnea and Seizure without ADHD,Dep,Anx Dont use sedative and immunosupresive drugs LFT belove 3 times normal without HTN

Group1 tab Agomelatine 25 mg, group2 tab Melatonin 3mg for under 12 and Melatonin 5mg for above 12yrs on sleep dis in children and adolescents with ASD

Improve the score of CSHQ

Randomization: All eligible subjects will be randomly assigned to one of the two groups receiving melathionine and agomelatine with a ratio of 1:1. The randomization method will be permuted block randomization, which blocks will be done based on the sample size in sizes 2, 4, 6, 8 until the sample size is exhausted using the website https://icostatistics.shinyapps.io/randlist/. Patients will be included in each group based on the determined sample size and based on the list of randomized individuals (along with a specific research code for each individual)

In compliance with health principles,the melatonin and agomelatonin tablets will be removed from the original drug envelope by the clinic secretary and will be given to the parents in the nameless envelope according to the randomization table. With this method, the patient, parent, researcher and statistician do not know the type of medicine used by each patient.

The results of the data analysis will be published in the form of an article

After publication in domestic or foreign magazines

no body

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