Evaluation of the effect of melatonin on executive function of ADHD child with sleep problems

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20230524058282N1

Enrollment

Registered

2023-09-04

Start date

2023-06-19

Completion date

Unknown

Last updated

2023-10-16

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

Conditions

Attention deficit hyper active disorder (ADHD)/sleep disorder. Sleep disorder

Interventions

Intervention 1: Intervention group: administration of 5mg melatonin before sleep time /methyl phenydate 10mg morning for 1 month period. Intervention 2: Control group: placebo in the form of empty cap

Eligibility

Sex/Gender

All

Age

6 Years to 11 Years

Inclusion criteria

Inclusion criteria: Parental consent for participation of child in study Positive score in each of CSHQ subscales

Exclusion criteria

Exclusion criteria: Other neurodevelopmental disorders

Design outcomes

Primary

Measure	Time frame
Score of every BRIFE subscales. Timepoint: Completion of questionnaires at start and one month after intervention. Method of measurement: BRIFE questionnaires (behavioral rating inventory of executive function ).;Score of every CSHQ (child sleep habit questionnaire) subscales. Timepoint: Completion of questionnaires at start and one month after intervention. Method of measurement: CSHQ (child sleep habit questionnaire).;Change in clinical global impression test. Timepoint: Completion of questionnaires at start and one month after intervention. Method of measurement: Completion of global clinical scale by physician.	—

Measure

Time frame

Score of every BRIFE subscales. Timepoint: Completion of questionnaires at start and one month after intervention. Method of measurement: BRIFE questionnaires (behavioral rating inventory of executive function ).;Score of every CSHQ (child sleep habit questionnaire) subscales. Timepoint: Completion of questionnaires at start and one month after intervention. Method of measurement: CSHQ (child sleep habit questionnaire).;Change in clinical global impression test. Timepoint: Completion of questionnaires at start and one month after intervention. Method of measurement: Completion of global clinical scale by physician.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactForogh Soltaninejad

Esfahan University of Medical Sciences

soltaninejad.fg@gmail.com009832222127

Outcome results

None listed

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