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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UNKNOWN
PHASE3
120 participants
INTERVENTIONAL
2017-09-01
2019-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Melatonin
Melatonin 5 mg taken 30 minutes before bed time
Melatonin 5 mg
Melatonin 5 mg taken 30 minutes before bed time
Placebo
Placebo identical to melatonin capsule taken 30 min before bed time
Melatonin 5 mg
Melatonin 5 mg taken 30 minutes before bed time
Interventions
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Melatonin 5 mg
Melatonin 5 mg taken 30 minutes before bed time
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Has given written informed consent to participate in the study.
Exclusion Criteria
History of uncontrolled hypertension or a resting systolic blood pressure \> 140mmHg or diastolic blood pressure \> 90mmHg (Subjects with well controlled hypertension on a stable dose (2 months) of anti-hypertensives will be allowed to participate).
Major depression or anxiety disorder which is a focus of treatment or requires taking medication.
A lifetime history of psychosis or bipolar disorder Has any concurrent chronic or unstable medical condition that could confound with the results of safety assessments, increase risk to the subject or lead to difficulty complying with the protocol.
Subjects taking any medication with CNS effects Subjects with a history of two or more prior failed adequate trials of ADHD treatment due to adverse events.
Use of dietary supplements with potential CNS effect, including omega-3 supplements, 30 days before study initiation and throughout the study.
Clinical history of cognitive impairment in judgment of investigator. Pregnant or breast-feeding subjects. Women of childbearing potential must have a negative pregnancy test performed at screening visit prior to randomization. Women of childbearing potential must agree to use adequate birth control for the entire duration of the study.
Subjects with a current (within the last 3 months) DSM-V diagnosis of alcohol or drug abuse or dependence (excluding nicotine).
Has taken an investigational drug or taken part in a clinical trial within 30 days prior to screening.
Any other reason that, in the opinion of the investigator, prevents the subject from participating in the study or compromise the subject safety.
Previous use of melatonin or melatonin analogues
18 Years
60 Years
ALL
No
Sponsors
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Fundação de Amparo à Pesquisa do Estado de São Paulo
OTHER_GOV
University of Sao Paulo
OTHER
Hospital Israelita Albert Einstein
OTHER
Responsible Party
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Locations
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Hospital Albert Einstein
São Paulo, São Paulo, Brazil
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TDAHMEL
Identifier Type: -
Identifier Source: org_study_id
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