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Evening Dose of Immediate Release Methylphenidate on Sleep in Children With ADHD
NCT02638168Phase 4
Key facts
- Status
- Terminated
- Start
- Jan 2016
- Primary completion
- Jun 2018
- Countries
- 1
- Sponsor
- Penn State Health Milton S. Hershey Medical Center
- Modality
- Small Molecules
- Drugs
- methylphenidate
- Conditions
- attention deficit hyperactivity disorder (ADHD)behavioral insomnia of childhood (BIC)
01
Overview
Phase 4, randomised, double-blind trial in attention deficit hyperactivity disorder (ADHD) and behavioral insomnia of childhood (BIC) comparing Immediate Release Methylphenidate with Placebo (2 arms). Primary endpoint: Sleep Onset Latency as Reported on the Parent Completed Sleep Log at 3 weeks. Started Jan 2016; status: terminated.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Immediate Release Methylphenidate
0.3 mg/kg of Immediate Release Methylphenidate dosed 3 hours before bedtime.
Placebo
Inert placebo dosed 3 hours before bedtime.
03
Who it enrols
Children aged 6-12 with ADHD and Behavioral Insomnia of Childhood, on a stable morning dose of Methylphenidate, excluding those with sleep-disordered breathing or other psychiatric/medical conditions impacting sleep.
04
Endpoints
Primary
Sleep Onset Latency as Reported on the Parent Completed Sleep Log
Secondary
Sleep Onset Latency, Defined as Time in Bed Until Sleep by Actigraphy
Pittsburgh Side Effects Rating Scale
Sleep Offset
Total Sleep Time
Wake After Sleep Onset
Sleep Efficiency
Number of Wakings
Length of Wakings
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