The efficacy and safety of melatonin treatment in children with attention deficit hyperactivity disorder (ADHD) and chronic sleep onset insomnia
Completed
- Conditions
- Attention deficit hyperactivity disorder, chronic sleep onset insomniaMental and Behavioural DisordersHyperkinetic disorders
- Registration Number
- ISRCTN47283236
- Lead Sponsor
- niversity Maastricht (The Netherlands)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 110
Inclusion Criteria
1. ADHD
2. Chronic sleep onset insomnia
3. Aged 6 - 12 years, boys/girls
4. Intelligence quotient (IQ) greater than 80
Exclusion Criteria
1. Epilepsy
2. Chronic pain
3. Renal/hepatic diseases
4. Pervasive developmental disorder
5. Used stimulants, melatotin, neuroleptics, benzodiazepines, clonidin, antidepressants, hypnotics, or beta blockers within four weeks before enrolment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method