Melatonin Effects in Ritalin Treated Children with Attention Deficit Hyperactivity Disorder

Melatonin Effects on Sleep Patterns, Symptoms of Hyperactivity and Attention Deficiency in Ritalin Treated Children with Attention Deficit Hyperactivity Disorder: A Randomized Double Blind Clinical Trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT201203167462N4

Enrollment

Registered

2012-03-17

Start date

2012-03-17

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Attention Deficit Hyperactivity Disorder (ADHD). Disturbance of activity and attention

Interventions

Intervention 1: Control: Methylphenidate (Ritalin: 1mg/kg) combined with Placebo taking 1 hour befor bed time. Intervention 2: Intervention group: Methy phenidate (Ritlin: 1mg/kg) combined with Melato

Treatment - Drugs

Placebo

Control: Methylphenidate (Ritalin: 1mg/kg) combined with Placebo taking 1 hour befor bed time

Intervention group: Methy phenidate (Ritlin: 1mg/kg) combined with Melatonin (Nutricentury: 3 or 6 mg ) taking 1 hour befor bed time

Eligibility

Sex/Gender

All

Age

7 Years to 12 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Age range of 7-12; ADHD combined form; Clinical need to treat with Methylphenidate; parental consent and child ascent Exclusion criteria: any confounding co-morbiditis; any drug supplements or narcotics consumption; Children with history of major prenatal complications such as prematurity, low birth weight (reported by parents), any past or present psychosis, comorbid tourette syndrome, celiac, phenylketonuria, autism, or other persistent developmental disorders

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Sleep disorders score. Timepoint: 0-2-4-8 weeks. Method of measurement: Sleep disorders scale for chilldren (SDSC).;Appetite score. Timepoint: 0-2-4-8 weeks. Method of measurement: Standard appetite questionnaire for chilldren.;Attention deficiency score and Hyperactivity score. Timepoint: 0-2-4-8 weeks. Method of measurement: ADHD rating scale for children (complited by parents).	—

Secondary

Measure	Time frame
Stimulants side effects. Timepoint: week 8. Method of measurement: Stimulants side effects questionnare.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSeyed Ali Mostafavi

Tehran University of Medical Sciences

mostafavi.n80@hotmail.com00

Outcome results

None listed

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