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Melatonin for Initial Insomnia in Children With ADHD
NCT02333149Phase 3
Key facts
- Status
- Withdrawn
- Start
- Jan 2019
- Primary completion
- Nov 2021
- Countries
- 1
- Sponsor
- University of Alberta
- Modality
- Small Molecules
- Drugs
- melatonin
- Conditions
- Insomnia
01
Overview
Phase 3, randomised, triple-blind trial in Insomnia comparing Melatonin with Placebo (2 arms). Primary endpoint: Sleep Onset Latency at 6 weeks. Planned start Jan 2019; status: withdrawn.
02
Design
2 arms- Study design
- RandomizedTriple-blind
Melatonin
Dietary supplement: Melatonin 3 mg or 6 mg
Placebo
Drug: Placebo
03
Who it enrols
School-aged children and adolescents (6-17 years) with a confirmed diagnosis of ADHD, excluding those with co-morbid psychiatric/neurological diagnoses affecting sleep, seizure disorders, sleep disorders, concurrent use of specific medications, or who are pregnant/breastfeeding.
04
Endpoints
Primary
Sleep Onset Latency
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