Melatonin in Youth: N-of-1 Trials in a Stimulant-treated Attention Deficit Hyperactivity Disorder (ADHD) Population (MYNAP)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02333149|
Recruitment Status : Active, not recruiting
First Posted : January 7, 2015
Last Update Posted : April 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|Attention Deficit/Hyperactivity Disorder Initial Insomnia||Dietary Supplement: Melatonin Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Melatonin in Youth: N-of-1 Trials in a Stimulant-treated Attention Deficit Hyperactivity Disorder (ADHD) Population|
|Actual Study Start Date :||January 1, 2019|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2022|
Dietary supplement: Melatonin 3 mg or 6 mg
Dietary Supplement: 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 Comparator: Placebo
Placebo frequency and volume are identical to the experimental arm
- Mean change in sleep onset latency (minutes) [ Time Frame: Daily, up to 6 weeks ]The mean change in sleep onset latency will be measured using sleep diaries.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02333149
|University of Alberta|
|Edmonton, Alberta, Canada, T6G 1K8|
|Principal Investigator:||Sunita Vohra, MD||University of Alberta|