EUCTR2019-000211-80-DKActive, not recruitingPhase 1
Melatonin – production and release in children and adolescents with ADHD and chronic sleep problems
Child and adolescent Psychiatry, South Jutland0 sites60 target enrollmentStarted: June 20, 2019Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 60
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
Inclusion Criteria
- •Children aged 6-12 years referred to the child and adolescent psychiatric department for examination/treatment for ADHD.
- •Diagnosed with ADHD (ICD-10)
- •Sleeping problems verified by Actigraphy
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 60
- •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
- •Ongoing treatment for sleep disturbances (melatonin, other sleep-regulating medication, weighted blankets) (all purposes)
- •IQ below 70
- •allergy to melatonin
Investigators
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