Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2025-12-25 @ 10:33 PM
Study NCT ID:
NCT04318067
Status:
UNKNOWN
Last Update Posted:
2022-05-09
First Post:
2020-02-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Melatonin in ADHD and Sleep Problems
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D020447', 'term': 'Parasomnias'}], 'ancestors': [{'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008550', 'term': 'Melatonin'}], 'ancestors': [{'id': 'D014363', 'term': 'Tryptamines'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2024-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-06', 'studyFirstSubmitDate': '2020-02-14', 'studyFirstSubmitQcDate': '2020-03-20', 'lastUpdatePostDateStruct': {'date': '2022-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sleep onset Latency (SOL)', 'timeFrame': '6 month', 'description': 'How long time does the child use falling asleep after lights out'}, {'measure': 'Sleep onset', 'timeFrame': '6 month', 'description': 'Time where child falls asleep'}, {'measure': 'Total Sleep time', 'timeFrame': '6 month'}], 'secondaryOutcomes': [{'measure': 'Attention Deficit Hyperactivity Disorder - Scale Score (ADHD-RS)', 'timeFrame': '6 month', 'description': 'A Scale Score measuring ADHD symptoms on a 4 point Likert Scale (0-3) . 18 Question with a Total max score of 54, Total minimum Score is 0 . Higher score is more symptoms.'}, {'measure': 'Weiss Functional Impairment Rating Scale (WFIRS)', 'timeFrame': '6 month', 'description': 'Evaluation on different Quality of Life (QoL) scores. 50 Question Measuring QoL in School, Family setting and Social activities on a 4 Point Likert Scale (0-3) with af total max score om 150 (minimum 0) - A higher score is more difficulties and lower Quality of Life'}, {'measure': 'Dundee Difficult Times of the Day Scale (D-DTODS)', 'timeFrame': '6 month', 'description': 'On a 4 point Likert scale (1-4) the instrument asses the impact on Child and Family Self-Esteem and Quality of Life . Total max is 40 points and indicates low QoL and Minimum score is 10 and indicate Normal functioning and High QoL'}, {'measure': 'Side effect Rating Scale', 'timeFrame': '6 month', 'description': 'Registration of 17 known possible Side Effekts on a Likert Scale 0-9 point each, With a total score of 153 points which indicate many and serious Side effect and a minimum of 0 , which indicate Zero side effects'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Melatonin', 'Attention Deficit Hyperactivity Disorder', 'Sleep problems', 'Dim Light Melatonin Onset'], 'conditions': ['Attention Deficit Hyperactivity Disorder', 'Sleep Disorder']}, 'descriptionModule': {'briefSummary': 'Treatment with melatonin is often initiated on an insufficient basis as it has not been established prior to starting the treatment whether or not the child had delayed release of endogenous melatonin. At the clinic, it has furthermore been observed that the length of time a child experiences an effect of melatonin treatment varies substantially.\n\nIn a clinical context, treatment with melatonin is used increasingly (www.Medstat.dk). However, there is no tradition in Denmark for measuring the endogenous melatonin level before initiating such treatment. Hence there is no way of knowing to what extent the sleep problems were indeed caused by delayed melatonin release.\n\nThere seem to be no studies on the difference in the effect of melatonin treatment of children and adolescents depending on whether or not they have delayed DLMO. Likewise, there are no studies including adolescents.\n\nAs can be seen, it is important to gain more knowledge about the normal release of melatonin, and the release of melatonin in a group of children and adolescents with a variety of psychiatric diagnoses. It is also essential to investigate whether there are any differences in the release of melatonin in children and adolescents with chronic sleep onset problem and children and adolescents who do not have sleep problems.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '13 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children aged 6-13 years referred to the child and adolescent psychiatric department for examination/treatment for ADHD\n* Verified Cronical Sleep Problems\n* Measured Dim Light Melatonin Onset\n\nExclusion Criteria:\n\n* IQ below 70\n* Autism Disorder\n* Actual or former treated with Melatonin\n* Allergy to melatonin'}, 'identificationModule': {'nctId': 'NCT04318067', 'acronym': 'MELAS', 'briefTitle': 'Melatonin in ADHD and Sleep Problems', 'organization': {'class': 'OTHER', 'fullName': 'Region of Southern Denmark'}, 'officialTitle': 'Melatonin - Production and Release in Children and Adolescents With ADHD and Chronic Sleep Problems and Effects of Melatonin on Sleep', 'orgStudyIdInfo': {'id': '18081070'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sleep problems i Attention Deficit Hyperactivity Disorder', 'description': 'Children age 6 to 12 years having ADHD and Sleeping problem will be treated with Melatonin 3 mg one a day (before bedtime)', 'interventionNames': ['Drug: Melatonin 3 mg']}], 'interventions': [{'name': 'Melatonin 3 mg', 'type': 'DRUG', 'description': 'Melatonin 3 mg is given ones a day - at bedtimes for 6 month', 'armGroupLabels': ['Sleep problems i Attention Deficit Hyperactivity Disorder']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6715', 'city': 'Esbjerg', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Allan Hvolby, M.D., Ph.D', 'role': 'CONTACT', 'email': 'allan.hvolby@rsyd.dk'}], 'facility': 'Child and Adolescent Psychiatric department', 'geoPoint': {'lat': 55.47028, 'lon': 8.45187}}], 'centralContacts': [{'name': 'Allan Hvolby, MD, Ph.D', 'role': 'CONTACT', 'email': 'allan.hvolby@rsyd.dk', 'phone': '0045 99447300'}], 'overallOfficials': [{'name': 'Allan Hvolby, MD, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Child and adolescent Psychiatric department, South Jutland'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allan Hvolby', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sygehus Lillebaelt', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, MD, Ph.D', 'investigatorFullName': 'Allan Hvolby', 'investigatorAffiliation': 'Region of Southern Denmark'}}}}