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The efficacy and safety of melatonin treatment in children with ADHD and chronic sleep onset insomnia.


- candidate number0
- NTR NumberNTR69
- ISRCTNISRCTN47283236
- Date ISRCTN created12-sep-2005
- date ISRCTN requested15-aug-2005
- Date Registered NTR8-aug-2005
- Secondary IDsN/A 
- Public TitleThe efficacy and safety of melatonin treatment in children with ADHD and chronic sleep onset insomnia.
- Scientific TitleThe efficacy and safety of melatonin treatment in children with ADHD and chronic sleep onset insomnia.
- ACRONYMMACI
- hypothesisN/A
- Healt Condition(s) or Problem(s) studiedInsomnia, Attention Deficit Hyperactivity Disorder (ADHD), Melatonin
- Inclusion criteria1. ADHD,
2. chronic sleep onset insomnia,
3. aged 6-12 yrs,
4. boys/girls,
5. IQ>80.
- Exclusion criteria1. Epilepsy,
2. chonic 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-nov-2001
- planned closingdate1-nov-2005
- Target number of participants110
- InterventionsMelatonin (3 mg when body weight <40 kg; 6 mg >40 kg) or placebo during 1 month at 19:00 h.
- Primary outcome1. Sleep onset, - latency, and total sleep duration as estimated with actigraphy and sleep log;
2. Salivary dim light melatonin onset (DLMO).
Measurements take place at baseline, in the third week of a placebo-controlled treatment period.
- Secondary outcome1. Computerized measures of sustained attention and response inhibition;
2. Severity of ADHD symptoms
3. quality of life;
3. side effects.
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIES Kristiaan B. Heijden, van der
- CONTACT for SCIENTIFIC QUERIES Kristiaan B. Heijden, van der
- Sponsor/Initiator Hospital Gelderse Vallei, Epilepsy Centre Kempenhaeghe, The Maarten Kapelle Foundation, Foundation “De Drie Lichten”
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC), Hospital Gelderse Vallei Ede, Epilepsy Centre Kempenhaeghe Heeze, Foundation “De Drie Lichten”, The Maarten Kapelle Foundation
- PublicationsJ Am Acad Child Adolesc Psychiatry. 2007 Feb;46(2):233-41.
- Brief summaryParticipating centres:
Hospital Gelderse Vallei, Ede, The Netherlands;
Epilepsy Centre Kempenhaeghe, Heeze, The Netherlands;
Reinier de Graaf Gasthuis, Delft, The Netherlands;
Department of Paediatrics, Rode Kruis Ziekenhuis, Beverwijk, The Netherlands.
- Main changes (audit trail)
- RECORD8-aug-2005 - 15-sep-2008


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