The efficacy and safety of melatonin treatment in children with attention deficit hyperactivity disorder (ADHD) and chronic sleep onset insomnia
| ISRCTN | ISRCTN47283236 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47283236 |
| Protocol serial number | NTR69 |
| Sponsor | University Maastricht (The Netherlands) |
| Funders | Foundation De Drie Lichten (The Netherlands), The Maarten Kapelle Foundation (The Netherlands), Epilepsy Centre Kempenhaeghe Heeze (The Netherlands), Hospital Gelderse Vallei Ede (The Netherlands), Academic Medical Centre (AMC) (The Netherlands) |
- Submission date
- 12/09/2005
- Registration date
- 12/09/2005
- Last edited
- 17/09/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Kristiaan B van der Heijden
Scientific
Scientific
Transvaalstraat 86-c
Amsterdam
1092 HP
Netherlands
| Phone | +31 (0)61 986 4148 |
|---|---|
| kbvanderheijden@hotmail.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre, randomised, double blind, placebo controlled, parallel group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | MACI |
| Study objectives | To assess the efficacy and safety of melatonin treatment in children with attention deficit hyperactivity disorder (ADHD) and chronic sleep onset insomnia. |
| Ethics approval(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Attention deficit hyperactivity disorder, chronic sleep onset insomnia |
| Intervention | Melatonin (3 mg when body weight less than 40 kg; 6 mg greater than 40 kg) or placebo during 1 month at 19:00 hours. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Melatonin |
| Primary outcome measure(s) |
1. Sleep onset, latency, and total sleep duration as estimated with actigraphy and sleep log |
| Key secondary outcome measure(s) |
1. Computerised measures of sustained attention and response inhibition |
| Completion date | 01/11/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Years |
| Upper age limit | 12 Years |
| Sex | All |
| Target sample size at registration | 110 |
| Key inclusion criteria | 1. ADHD 2. Chronic sleep onset insomnia 3. Aged 6 - 12 years, boys/girls 4. Intelligence quotient (IQ) greater than 80 |
| Key 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 |
| Date of first enrolment | 01/11/2001 |
| Date of final enrolment | 01/11/2005 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Transvaalstraat 86-c
Amsterdam
1092 HP
Netherlands
1092 HP
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
