Ignite Creation Date:
2025-12-24 @ 6:56 PM
Ignite Modification Date:
2026-01-01 @ 8:28 PM
Study NCT ID:
NCT06380257
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-23
First Post:
2024-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anorexia Nervosa and Brain in Adolescence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000856', 'term': 'Anorexia Nervosa'}], 'ancestors': [{'id': 'D001068', 'term': 'Feeding and Eating Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2030-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-18', 'studyFirstSubmitDate': '2024-04-05', 'studyFirstSubmitQcDate': '2024-04-18', 'lastUpdatePostDateStruct': {'date': '2024-04-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Psychiatric evaluation', 'timeFrame': "Baseline and at 3 years' follow-up", 'description': 'Self-rated questionnaires measuring somatic and mentalh health (such as EDE-Q, BDI, substance use measurements) and structured psychiatric diagnostic interview (SCID)'}, {'measure': 'Body composition measurement', 'timeFrame': "Baseline and at 3 years' follow-up", 'description': 'InBody body composition measurement (non-invasive method to measure information about the quantity and segmentation of muscle, bone and fat tissue in body and about your basal metabolic rate)'}, {'measure': 'Laboratory tests', 'timeFrame': "Baseline and at 3 years' follow-up", 'description': 'Blood sample (markers describing undernourishment, more precise description before study)'}], 'primaryOutcomes': [{'measure': 'Neuroimaging', 'timeFrame': "Baseline and at 3 years' follow-up", 'description': 'Transcranial magnetic stimulation (TMS) combined with electroencephalogram (EEG)'}], 'secondaryOutcomes': [{'measure': 'Neuroimaging', 'timeFrame': "Baseline and at 3 years' follow-up", 'description': 'Magnetic resonance imaging (MRI)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anorexia Nervosa']}, 'descriptionModule': {'briefSummary': 'Aims of this follow-up study are to investigate effects of anorexia nervosa on brain structure and functions in adolescence.', 'detailedDescription': 'Anorexia nervosa is severe mental health problem with increased incidence rates in adolescence. Etiology of anorexia nervosa is still mostly unkonwn. Adolescence is also critical period of brain development.\n\nAims of this follow-up study are to investigate effects of anorexia nervosa on brain structure and functions in both acute and remission state of anorexia nervosa in adolescence.\n\nStudy group are young anorexia nervosa patients, and control group are healthy same-aged students.\n\nResearch methods include non-invasive brain imaging methods such as Transcranial Magnetic Stimulation (TMS), and Magnetic Resonance Imaging (MRI). Other research methods are assessment of body composition, laboratory tests, self-rated questionnaires and psychiatric interview.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '19 Years', 'minimumAge': '16 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Target study population is 50 participants. Study group (25 participants) are recruited from North Savo wellbeing services, Adolescent psychiatry outpatient clinic. Control group (25 participants) are recruited from Kuopio restrict lower and upper secondary schools.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nStudy group: 1) age 16-19 years, 2) BMI below 17.5, 3) diagnosis: anorexia nervosa or atypical anorexia nervosa 4) diagnosed within last two years. Inclusion criteria.\n\nControl group : 1) age 16-19 years, 2) BMI over 19.0, 3) No lifetime obesity (BMI over 30) nor eating disorder.\n\nExclusion Criteria:\n\n1\\) glucose metabolism disorder or any chronic medical disorder, or medicine with possible effects on neurotransmitters, 2) previous mental health problem (excluded anorexia nervosa or atypical anorexia nervosa in study group), 3) smoking, nicotine products, alcohol or any other substance abuse or dependence, 4) contraindication for used brain imaging method.'}, 'identificationModule': {'nctId': 'NCT06380257', 'briefTitle': 'Anorexia Nervosa and Brain in Adolescence', 'organization': {'class': 'OTHER', 'fullName': 'Kuopio University Hospital'}, 'officialTitle': 'Anorexia Nervosa and Brain in Adolescence', 'orgStudyIdInfo': {'id': 'ANBA'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study group', 'description': 'Adolescents diagnosed with anorexia nervosa or atypical anorexia nervosa.', 'interventionNames': ['Other: Observational study methods']}, {'label': 'Control Group', 'description': 'Healthy adolescents.', 'interventionNames': ['Other: Observational study methods']}], 'interventions': [{'name': 'Observational study methods', 'type': 'OTHER', 'description': 'Neuroimaging, body compostion, laboratory tests and psychiatric interview in study and in control groups.', 'armGroupLabels': ['Control Group', 'Study group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Virve Kekkonen, M.D.', 'role': 'CONTACT', 'email': 'virve.kekkonen@pshyvinvointialue.fi', 'phone': '+35817173311'}], 'overallOfficials': [{'name': 'Virve Kekkonen, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kuopio University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kuopio University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Specialist in adolescent psychiatry, clinical lecturer', 'investigatorFullName': 'Virve Kekkonen', 'investigatorAffiliation': 'Kuopio University Hospital'}}}}