Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2025-12-31 @ 3:49 AM
Study NCT ID:
NCT05910957
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-08-03
First Post:
2023-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multi-Omic, Clinomic and Digitomic Attributes of Major Depression for Integrative Analytics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'This study will collect 20 mL of blood for biomarker discovery efforts. Specifically, this study will collect and store blood samples that will be used in the future to derive C-reactive protein (CRP) levels, genome-wide genomics, proteomics, metabolomics, and exposomics.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2023-08-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-12-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-30', 'studyFirstSubmitDate': '2023-06-11', 'studyFirstSubmitQcDate': '2023-06-11', 'lastUpdatePostDateStruct': {'date': '2025-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Quick Inventory of Depressive Symptoms-Clinician Rated (QIDS-CR) scale', 'timeFrame': 'Baseline, 4 weeks, and 8 weeks', 'description': 'The Quick Inventory of Depressive Symptoms-Clinician Rated is used for rating the severity of depressive symptoms. Possible scores range from 0 to 27, with higher scores indicating greater severity of depression.'}], 'secondaryOutcomes': [{'measure': 'Change in Hamilton Depression Rating Scale', 'timeFrame': 'Baseline, 4 weeks, and 8 weeks', 'description': 'The Hamilton Depression Rating Scale is used for rating the severity of depressive symptoms. Possible scores range from 0 to 50, with higher scores indicating greater severity of depression.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Major Depressive Disorder', 'Unipolar, Non-psychotic Major Depressive Disorder']}, 'descriptionModule': {'briefSummary': 'The purpose of this research is to see if information from blood and data from smartwatches can be combined to help diagnose depression and determine if transitions between active depression and treated depression can be predicted.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '62 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects will be recruited from an ongoing cohort study at Mayo Florida "Wearable Augmented Prediction of Burnout in Nurses: A Synergy of Engineering, Bioethics, Nursing and Wellness Sciences" (BROWNIE Study)', 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participated in the BROWNIE study.\n* DSM-5 diagnostic criteria are met for unipolar, non-psychotic MDD (excluding controls).\n* A score of \\> 10 on the QIDS-C and QIDS-SR (equivalent to 13 or greater on HAM-D17) given that when medication exceeds the effect of placebo in primary care participants have a HAM-D17 \\>12 (excluding controls).\n* Antidepressant treatment is deemed appropriate by a study clinician (excluding controls).\n* Smart watch wear time is at least 70% during their participation in the BROWNIE study.\n\nExclusion Criteria:\n\n* Subjects with medical contraindications that preclude treatment with study drugs will be excluded.\n* Patients with schizophrenia, schizoaffective disorder, or who have bipolar I or II disorder (or another specified or unspecified bipolar spectrum disorder) will be excluded because they have a primary psychiatric condition that requires a different initial treatment.\n* Subjects currently on antidepressant medication with subtherapeutic results in terms of depression management will undergo a medication taper and discontinuation prior to initiation of a new study medication. The subject will be closely monitored by the study clinician during the medication taper and discontinuation phase. The medication taper is left up to the study clinician's discretion. Study subjects who cannot be safely tapered from their medication or experience adverse effects during the taper will be excluded from the study.\n* Subjects who have an active substance use disorder will be excluded. An active substance use disorder will be defined as meeting DSM-5 diagnostic criteria for any active substance use disorder. Persons meeting DSM-5 diagnostic criteria for a substance use disorder in full remission (\\>12 months) and a negative urine drug of abuse screen at the screening visit or before the baseline study visit will be considered eligible. Persons with a positive urine drug of abuse screen may participate in the study if they do not meet DSM-5 diagnostic criteria for a substance use disorder.\n* Subjects unable to give informed consent or who are unwilling or unable to comply with study requirements are excluded.\n* Pregnant subjects will be excluded.\n* Subjects who are currently breastfeeding and who plan to continue breastfeeding will be excluded.\n* Subjects who are psychiatrically hospitalized or in a mental health crisis requiring urgent care or psychiatric hospitalization.\n* Study subjects currently on antipsychotic medications (e.g., typical, and atypical antipsychotic drugs) taken for primary psychotic illness or affective psychosis will be excluded.\n* Study subjects taking mood stabilizing agents (e.g., lithium, carbamazepine, valproate, lamotrigine, gabapentin, or other anticonvulsants) taken specifically for bipolar spectrum disorders are not eligible for participation."}, 'identificationModule': {'nctId': 'NCT05910957', 'briefTitle': 'Multi-Omic, Clinomic and Digitomic Attributes of Major Depression for Integrative Analytics', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Multi-Omic, Clinomic and Digitomic Attributes of Major Depression for Integrative Analytics: the MACADAMIA Pilot Study', 'orgStudyIdInfo': {'id': '23-002931'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Non-depressed controls', 'description': 'Subjects without depression will fill out questionnaires about their general health and wellbeing, quality of life, mental health, emotional health, suicide risk, support system, and childhood experiences. Smartwatch data will also be collected to monitor step count, sleep quality, heart rate (resting and active), and activity rates.'}, {'label': 'Antidepressant-treated adults', 'description': 'Subjects diagnosed with depression will fill out questionnaires about their general health and wellbeing, quality of life, mental health, emotional health, suicide risk, support system, and childhood experiences. Smartwatch data will also be collected to monitor step count, sleep quality, heart rate (resting and active), and activity rates.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Mayo Clinic Florida', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}], 'overallOfficials': [{'name': 'Mohit Chauhan, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'Florida State University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mohit Chauhan, M.B.B.S.', 'investigatorAffiliation': 'Mayo Clinic'}}}}