Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
147 participants
INTERVENTIONAL
2022-07-18
2025-01-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Melatonin
Melatonin
Melatonin
Melatonin 2 mg daily for 4 weeks
Placebo
Placebo
Placebo
Placebo daily for 4 weeks
Interventions
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Melatonin
Melatonin 2 mg daily for 4 weeks
Placebo
Placebo daily for 4 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Children with liver or kidney dysfunction
* Children on hypnotics, antidepressants, or anxiolytics within 4 weeks before the baseline clinic visit
* Adolescent girls who are pregnant or breastfeeding
* Adolescent girls who have sexual activities but cannot take effective contraceptive measures during the trial
1 Year
18 Years
ALL
No
Sponsors
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National Taiwan University Hospital
OTHER
Responsible Party
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Principal Investigators
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Wang-Tso Lee
Role: PRINCIPAL_INVESTIGATOR
National Taiwan University Hospital
Locations
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National Taiwan University Hospital
Taipei, , Taiwan
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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202012143MIPC
Identifier Type: -
Identifier Source: org_study_id
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