Melatonin in Youth: N-of-1 Trials in a Stimulant-treated Attention Deficit Hyperactivity Disorder (ADHD) Population
NCT ID: NCT02333149
Last Updated: 2021-11-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
INTERVENTIONAL
2019-01-01
2021-11-04
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Melatonin
Dietary supplement: Melatonin 3 mg or 6 mg
Melatonin
Children \<40 kg will take one tablet, melatonin 3 mg, oral, 30 - 60 minutes prior to bedtime.
Children ≥40 kg will take two tablets, melatonin 3 mg, oral, 30-60 minutes prior to bedtime.
Placebo
Drug: Placebo
Placebo
Placebo frequency and volume are identical to the experimental arm
Interventions
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Melatonin
Children \<40 kg will take one tablet, melatonin 3 mg, oral, 30 - 60 minutes prior to bedtime.
Children ≥40 kg will take two tablets, melatonin 3 mg, oral, 30-60 minutes prior to bedtime.
Placebo
Placebo frequency and volume are identical to the experimental arm
Eligibility Criteria
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Inclusion Criteria
* Confirmed diagnosis of ADHD as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)
Exclusion Criteria
* Co-morbid seizure disorder
* Co-morbid sleep disorder
* Concurrent use of immunosuppressive drugs, blood pressure drugs, selective serotonin re-uptake inhibitors or anticoagulant drugs;
* Pregnancy or breastfeeding
6 Years
17 Years
ALL
No
Sponsors
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The University of Queensland
OTHER
University of Alberta
OTHER
Responsible Party
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Principal Investigators
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Sunita Vohra, MD
Role: PRINCIPAL_INVESTIGATOR
University of Alberta
Locations
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University of Alberta
Edmonton, Alberta, Canada
Countries
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References
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Punja S, Nikles CJ, Senior H, Mitchell G, Schmid CH, Heussler H, Witmans M, Vohra S. Melatonin in Youth: N-of-1 trials in a stimulant-treated ADHD Population (MYNAP): study protocol for a randomized controlled trial. Trials. 2016 Jul 29;17:375. doi: 10.1186/s13063-016-1499-6.
Other Identifiers
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Pro00022025
Identifier Type: -
Identifier Source: org_study_id