Effect of Ritalin with and without Melatonin on the quality of sleep and the severity of clinical symptoms in children with attention deficit hyperactivity disorder

Effect of Ritalin with and without Melatonin on the quality of sleep and the severity of clinical symptoms in children with attention deficit hyperactivity disorder: a randomized clinical trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20120215009014N235

Enrollment

Registered

2018-09-22

Start date

2017-12-01

Completion date

Unknown

Last updated

2018-10-11

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

Conditions

Attention deficit hyperactivity disorder. Attention-deficit hyperactivity disorder, unspecified type

Interventions

Intervention 1: Intervention group: Tablet Ritalin 5 mg to 40 mg daily for one month plus tablet Melatonin 3 mg once a night for 10 days. Intervention 2: Control group: Tablet Ritalin 5 mg to 40 mg da

Eligibility

Sex/Gender

All

Age

5 Years to 10 Years

Inclusion criteria

Inclusion criteria: Age of 5 to 10 years; Attention deficit hyperactivity disorder; Sleep disorder

Exclusion criteria

Exclusion criteria: Phenylketonuria; Depression; Mental retardation; Using hypnotic drugs

Design outcomes

Primary

Measure	Time frame
Assessing the sleep quality. Timepoint: At baseline and then one and two months after intervention. Method of measurement: Using children sleep habit questionnaire (CSHQ).;Assessing the severity of clinical symptoms. Timepoint: At baseline and then one and two months after intervention. Method of measurement: Using Conner questionnaire.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactGhazal Sami

Hamedan University of Medical Sciences

medicine372@yahoo.com+98 81 3364 0030

Outcome results

None listed

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