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Comparison Effectiveness of Melatonin and Clonidine in Treatment of Insomnia in Children with Attention Deficit Hyperactivity Disorder: Randomized Controlled Trial

Comparison Effectiveness of Melatonin and Clonidine in Treatment of Insomnia in Children with Attention Deficit Hyperactivity Disorder: Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20230821001
Enrollment
96
Registered
2023-08-21
Start date
2021-07-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Insomnia in ADHD children 6-12 years old ADHD, Attention deficit hyperactivity disorder, insomnia, clonidine, melatonin

Interventions

Participants in clonidine group received tablet containing 0.15 mg of clonidine. Starting dose was 0.038 mg/day (1/4 tablet). After 1 week of treatment, sleep variables were evaluated via telephone. I
Active Comparator Drug,Active Comparator Drug
Short-acting clonidine,Prolonged-release melatonin

Sponsors

Pramonkutklao Foundation
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 12 Years

Inclusion criteria

Inclusion criteria: Children aged 6-12 years old who met Diagnostic and Statistical Manual of Mental Disorders fifth edition (DSM-5) of Attention-Deficit/Hyperactivity Disorder (ADHD) and met criteria of chronic insomnia disorder from International Classification of Sleep Disorder third edition (ICSD 3rd edition)

Exclusion criteria

Exclusion criteria: established diagnosis of autism spectrum disorder, intellectual disability, genetic syndrome, obstructive sleep apnea, adjusting dose of ADHD medication, ongoing insomnia treatment, allergic to clonidine or melatonin, using sedative agent and caregiver unable to record sleep diary

Design outcomes

Primary

MeasureTime frame
Sleep onset, sleep latency, total sleep time and night awakening after receive steady dose of medication for 4 weeks sleep diary

Secondary

MeasureTime frame
Sleep behaviors and difficulties after receive steady dose of medication for 4 weeks Children's Sleep Habits Questionnaire-Thai version,ADHD symptoms after receive steady dose of medication for 4 weeks Vanderbilt Attention-Deficit/Hyperactivity Disorder Diagnostic Parent Rating Scales (VADPRS),Auditory attention after receive steady dose of medication for 4 weeks Developmental Neurophychological Assessment Second Edition (NEPSY-II) auditory attention task

Countries

Thailand

Contacts

Public ContactCharnunnut Tiyapsane

Pramongkutklao hospital

charnunnut332@gmail.com66869949819

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026