The efficacy and safety of melatonin treatment in children with ADHD and chronic sleep onset insomnia.
Completed
- Registration Number
- NL-OMON25413
- Brief Summary
J Am Acad Child Adolesc Psychiatry. 2007 Feb;46(2):233-41.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 110
Inclusion Criteria
1. ADHD,
2. chronic sleep onset insomnia,
Exclusion Criteria
1. Epilepsy,
2. chonic pain,
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Sleep onset, - latency, and total sleep duration as estimated with actigraphy and sleep log;<br /><br>2. Salivary dim light melatonin onset (DLMO). <br /><br>Measurements take place at baseline, in the third week of a placebo-controlled treatment period.
- Secondary Outcome Measures
Name Time Method 1. Computerized measures of sustained attention and response inhibition;<br /><br>2. Severity of ADHD symptoms <br /><br>3. quality of life;<br /><br>3. side effects.