Determine the influence of methylphenidate treatment on sleep-wake rhythm and endogenous melatonin rhythm.
ID
Source
Brief title
Condition
- Sleep disturbances (incl subtypes)
- Psychiatric disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary parameters: 1) sleep latency 2) sleep onset time; 3) total time
asleep; 4) Difficulty falling asleep (from actigraphy and sleep log) and dim
light melatonin onset (DLMO) from salivary melatonin
Secondary outcome
Not applicable.
Background summary
Disordered sleep is a common phenomenon among children with ADHD.
Methylphenidate therapy initiates or worsens sleep onset problems in a
substantial percentage of these children. The exact effect of methylphenidate
on sleep is unknown, but recent research suggests that methylphenidate may
affect sleep-wake rhythm by exerting effects on the biological clock and
thereby altering the endogenous circadian rhythm of melatonin.
Study objective
Determine the influence of methylphenidate treatment on sleep-wake rhythm and
endogenous melatonin rhythm.
Study design
Observational study in a group of children with ADHD who are assigned to a
short cross over trail of methylphenidate/placebo by the paediatricans.
Measurements of sleep using actigraphy and sleeplog, and of endogenous
melatonin from saliva are performed at baseline and in the second week of the
cross over trail.
Intervention
The first group will be treated with methylphenidate divided over the day in
two doses ( amount 0.5 mg/kg), the second group will be treated with placebo in
the same amount as the first group.
Study burden and risks
The burden of the study is wearing the actometer at night during the study
period and chewing on a cotton plug ( during 1minute) on 5 different time
points at 2 nights in the study period. Normally, in regular clinical practice,
these tests are not experienced as very demanding by the patient.
Potential risks are side effects caused by the methylphenidate therapy.
Willy Brandtlaan 10
6710 HN Ede
NL
Willy Brandtlaan 10
6710 HN Ede
NL
Listed location countries
Age
Inclusion criteria
Age 6-12 years
Recently diagnosed ADHD
Indication for starting with methylphenidate treatment and assignment by the paediatrician to a short methylphenidate/placebo trail.
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
Severe ADHD symptoms ( serious behavioural-, attention or learning problems heavily interfering with the child*s live ) in which no delay can be made with the initiation of methylphenidate treatment.
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| EudraCT | EUCTR2007-004664-46-NL |
| CCMO | NL19088.041.07 |