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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON25413

Enrollment

110

Registered

2005-08-08

Start date

2001-11-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Melatonin (3 mg when body weight 40 kg) or placebo during 1 month at 19:00 h.

Eligibility

Inclusion criteria

Inclusion criteria: 1. ADHD, 2. chronic sleep onset insomnia, 3. aged 6-12 yrs, 4. boys/girls, 5. IQ>80.

Exclusion criteria

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 outcomes

Primary

Measure	Time frame
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

Measure	Time frame
1. Computerized measures of sustained attention and response inhibition; 2. Severity of ADHD symptoms 3. quality of life; 3. side effects.	—

Contacts

Public ContactKristiaan B. Heijden, van der

Transvaalstraat 86-c

kbvanderheijden@hotmail.com+31 (0)6 19864148

Outcome results