Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 9:14 PM
Study NCT ID:
NCT07317895
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-05
First Post:
2025-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sensitivity to Ovarian Hormones and Depression in Adolescents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003244', 'term': 'Consciousness Disorders'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 94}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-19', 'studyFirstSubmitDate': '2025-12-19', 'studyFirstSubmitQcDate': '2025-12-19', 'lastUpdatePostDateStruct': {'date': '2026-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Identification ovarian hormone affect sensitivity', 'timeFrame': '90 days', 'description': 'Identify depressed adolescents assigned female at birth with depressed affect sensitivity to changes in ovarian hormones across the menstrual cycle.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Depression', 'Estrogen', 'Progesterone'], 'conditions': ['Depressed']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to learn about the relationship between changes in ovarian hormones (estrogen and progesterone) and adolescent depression. The main question it aims to answer is:\n\nCan we identify a subset adolescents assigned female at birth with a history of depression who are particularly sensitive to changes in ovarian hormones? Participants will be monitoring daily absolute ovarian hormone levels at home using the Mira Analyzer and answer online survey questions about their mental health for 90 days.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Depressed, naturally cycling adolescents assigned female at birth.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Assigned female at birth, at least 1 year post-menarche, naturally cycling, history of depression or symptoms of depression, and able to read and write in English.\n\nExclusion Criteria:\n\n* Pregnant or taking any hormonal or cycle altering medications/devices.'}, 'identificationModule': {'nctId': 'NCT07317895', 'acronym': 'SOHDA', 'briefTitle': 'Sensitivity to Ovarian Hormones and Depression in Adolescents', 'organization': {'class': 'OTHER', 'fullName': 'University of Calgary'}, 'officialTitle': 'Sensitivity to Ovarian Hormones and Depression in Adolescents', 'orgStudyIdInfo': {'id': 'REB25-1647'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'SOHDA corort', 'description': 'Main study cohort'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T2N1N4', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'contacts': [{'name': 'Whitney Hindmarch', 'role': 'CONTACT'}], 'facility': 'University of Calgary', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}], 'centralContacts': [{'name': 'Whitney Hindmarch, PhD', 'role': 'CONTACT', 'email': 'whitney.hindmarch@ucalgary.ca', 'phone': '587-534-7260'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Calgary', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Manager', 'investigatorFullName': 'Whitney Hindmarch', 'investigatorAffiliation': 'University of Calgary'}}}}