Influence of methylphenidate on sleep and circadian rhythm in children with Attention-Deficit/Hyperactivity Disorder (ADHD) - MELMET
- Conditions
- Sleep disorders in Attention-Deficit/ Hyperactivity Disorder (ADHD)
- Registration Number
- EUCTR2007-004664-46-NL
- Lead Sponsor
- o Sponsor
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Age 6-12 years
Recently diagnosed ADHD
Indication for starting with methylphenidate treatment
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
IQ<80
Treatment with stimulants, melatonin, clonidine, risperidon, benzodiazepines
Prior treatment with melatonin (>0.1 mg)
Contraindications for using methylfenidate
Tourette’s syndrome
Depression
Anxiety disorder
Pervasive developmental disorder
Psychosis
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Determine the influence of methylphenidate treatment on sleep-wake rhythm and endogenous melatonin rhythm in children with ADHD.;Secondary Objective: ;Primary end point(s): Primary parameters: 1) sleep latency 2) sleep onset time; 3) total time asleep ( from actigraphy); 4) Difficulty falling asleep (from sleep log) and dim light melatonin onset (DLMO) from salivary melatonin.
- Secondary Outcome Measures
Name Time Method