Influence of methylphenidate on sleep and circadian rhythm in children with Attention-Deficit/Hyperactivity Disorder (ADHD)

Phase 4

Withdrawn

• Conditions: Sleep onset insomnia; 10040998

• Registration Number: NL-OMON31584
• Lead Sponsor: Ziekenhuisvoorzieningen Gelderse Vallei

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 140

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.

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary parameters: 1) sleep latency 2) sleep onset time; 3) total time<br /><br>asleep; 4) Difficulty falling asleep (from actigraphy and sleep log) and dim<br /><br>light melatonin onset (DLMO) from salivary melatonin</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Not applicable.</p><br>