No registrations found.
ID
Source
Brief title
Intervention
Outcome measures
Primary outcome
1. 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 outcome
1. Computerized measures of sustained attention and response inhibition;
2. Severity of ADHD symptoms
3. quality of life;
3. side effects.
Background summary
Participating 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.
Study objective
N/A
Study design
N/A
Intervention
Melatonin (3 mg when body weight <40 kg; 6 mg >40 kg) or placebo during 1 month at 19:00 h.
Kristiaan B. Heijden, van der
Transvaalstraat 86-c
Amsterdam 1092 HP
The Netherlands
+31 (0)6 19864148
kbvanderheijden@hotmail.com
Kristiaan B. Heijden, van der
Transvaalstraat 86-c
Amsterdam 1092 HP
The Netherlands
+31 (0)6 19864148
kbvanderheijden@hotmail.com
Inclusion criteria
1. ADHD,
2. chronic sleep onset insomnia,
3. aged 6-12 yrs,
4. boys/girls,
5. IQ>80.
Exclusion criteria
1. 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL42 |
| NTR-old | NTR69 |
| Other | : N/A |
| ISRCTN | ISRCTN47283236 |