Effectiveness of adding melatonin and sleep hygiene education to the usual treatment of attention deficit hyperactivity disorder with sleep phase delay syndrome.

A comparative study of the effectiveness of adding melatonin and sleep hygiene education to the usual treatment (pharmacological and non-pharmacological treatment) in reducing the symptoms of attention deficit hyperactivity disorder in adolescents with attention deficit hyperactivity disorder and sleep phase delay syndrome.

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20211004052670N5

Enrollment

Registered

2023-11-13

Start date

2023-11-22

Completion date

Unknown

Last updated

2024-01-22

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

Conditions

Attention Deficit-Hyperactivity Disorder. Attention-deficit hyperactivity disorder, combined type

Interventions

Intervention 1: Intervention group 1: For each patient, 3 mg of melatonin is added to his routine treatment. The chemical structure of this drug is similar to serotonin. It has a fast and complete ora

Eligibility

Sex/Gender

All

Age

12 Years to 18 Years

Inclusion criteria

Inclusion criteria: Definitive diagnosis of ADHD with DSPS between 12 and 18 years Informed consent to participate in the research project Having minimum education (reading and writing literacy) of parents for sleep training for teenagers

Exclusion criteria

Exclusion criteria: Suffering from chronic physical diseases including diabetes, liver problems, immune system defects and autoimmune diseases Taking medicine with side effects of sleep problems such as insomnia or hypersomnia

Design outcomes

Primary

Measure	Time frame
Determining the mean scores of Conners Hyperactivity Questionnaire. Timepoint: The questionnaire is administered at the baseline visit (before the intervention), after participating in sleep health education sessions and taking melatonin medicine, and then three months after the intervention is completed for follow-up. Method of measurement: Conners Hyperactivity Questionnaire.	—

Secondary

Measure	Time frame
Sleep quality score. Timepoint: The questionnaire is administered at the baseline visit (before the intervention), after the training sessions on sleep hygiene and the use of melatonin medication, and three months after the end of the intervention for follow-up. Method of measurement: Petersburg Sleep Quality Questionnaire.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAfsaneh Karbasi Amel

Esfahan University of Medical Sciences

afsaneh_karbasi@med.mui.ac.ir+98 31 3641 1255

Outcome results

None listed

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