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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20230607058407N1

Enrollment

Registered

2023-10-30

Start date

2023-07-11

Completion date

Unknown

Last updated

2023-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Condition 1: Autism spectrum disorder. Condition 2: sleep disorder. Autistic disorder Insomnia

Interventions

Intervention 1: Control group: slow-release melatonin tab: half a tablet of 3 mg for the age of 3-5 years, one tablet of 3 mg for the age of 6-12, and melatonin 5mg for the age of 12-18, half an hour

Eligibility

Sex/Gender

All

Age

3 Years to 18 Years

Inclusion criteria

Inclusion criteria: children and adolescents with autism spectrum disorder and with sleep disorders

Exclusion criteria

Exclusion criteria: doubt to sleep apnea resistant patiants

Design outcomes

Primary

Measure	Time frame
Change the score of children sleep habits questannaire. Timepoint: at the beggining and 1 month later. Method of measurement: children sleep habits questannaire.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNezhla Mostafeenezhad

Shahid Beheshti University of Medical Sciences

Dr.nejla.mostafeenezhad@gmail.com+98 21 7755 1023

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026