Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2025-12-25 @ 9:15 PM
Study NCT ID:
NCT04430556
Status:
UNKNOWN
Last Update Posted:
2020-06-12
First Post:
2020-06-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Brain Hippocampal Volume Relationship With Anxious Symptoms in Major Depressive Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020280', 'term': 'Sertraline'}], 'ancestors': [{'id': 'D015057', 'term': '1-Naphthylamine'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-06-11', 'studyFirstSubmitDate': '2020-06-10', 'studyFirstSubmitQcDate': '2020-06-11', 'lastUpdatePostDateStruct': {'date': '2020-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response on Hamilton Anxiety Rating Scale', 'timeFrame': 'Change from baseline to week 8', 'description': 'The Hamilton Anxiety Rating Scale and its correlation with hippocampal size'}], 'secondaryOutcomes': [{'measure': 'Response on Clinical Global Impression-Improvement', 'timeFrame': 'Change from baseline to week 8', 'description': 'Difference between baseline and final score'}, {'measure': 'Response on Hamilton Depression Rating Scale', 'timeFrame': 'Change from baseline to week 8', 'description': 'Difference between baseline and final score'}, {'measure': 'Response on Montgomery-Asberg Scale for Depression', 'timeFrame': 'Change from baseline to week 8', 'description': 'Difference between baseline and final score'}, {'measure': 'Response on Columbia Scale for Suicidality', 'timeFrame': 'Change from baseline to week 8', 'description': 'Difference between baseline and final score'}, {'measure': 'Response on State-Trait Depression Inventory', 'timeFrame': 'Change from baseline to week 8', 'description': 'Difference between baseline and final score'}, {'measure': 'Response on Beck Anxiety Inventory', 'timeFrame': 'Change from baseline to week 8', 'description': 'Difference between baseline and final score'}, {'measure': 'Response on EQ-5D', 'timeFrame': 'Change from baseline to week 8', 'description': 'Difference between baseline and final score'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['major depressive disorder', 'hippocampal volume', 'cortisol', 'c-reactive protein', 'brain metabolites', 'MRI', 'anxiety'], 'conditions': ['Major Depressive Disorder', 'Anxiety Disorders']}, 'descriptionModule': {'briefSummary': 'The objective of this transversal study is to determine if there is a difference in the volume of the hippocampus with the degree of anxiety.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* First-time patients, without prior antidepressant treatment that meet the diagnostic criteria of DSM 5 for major depressive disorder.\n* Patients who meet the current major depressive disorder criteria in the MINI interview.\n* Patients who signed the informed consent for the investigation.\n\nExclusion Criteria:\n\n* Patients presenting insufficient data in the MINI interview for current major depression.\n* Patients diagnosed with intellectual development disorder, by clinic.\n* Patients with diagnosis of the schizophrenic spectrum, bipolar disorder, autism spectrum disorder, post-traumatic stress disorder and obsessive-compulsive disorder by clinic and / or by the MINI interview.\n* Patients with contraindications for MRI.\n* Patients with serious or unstable medical problems.\n* Patients undergoing some legal procedure.\n* Patients with difficulties in understanding the interview or completing the assessment instruments.'}, 'identificationModule': {'nctId': 'NCT04430556', 'briefTitle': 'Brain Hippocampal Volume Relationship With Anxious Symptoms in Major Depressive Patients', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitario Dr. Jose E. Gonzalez'}, 'officialTitle': 'Study on the Brain Hippocampal Volume, Cortisol and C-reactive Protein Levels Relationship With Anxious Symptoms in Major Depressive Patients', 'orgStudyIdInfo': {'id': 'PS18-00016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Volumetric changes in response to sertraline or escitalopram', 'interventionNames': ['Drug: Sertraline']}], 'interventions': [{'name': 'Sertraline', 'type': 'DRUG', 'description': 'Sertraline will be started in all patients, unless it is contraindicated, in this case, Escitalopram will be indicated.', 'armGroupLabels': ['Volumetric changes in response to sertraline or escitalopram']}]}, 'contactsLocationsModule': {'locations': [{'zip': '64460', 'city': 'Monterrey', 'state': 'Nuevo León', 'country': 'Mexico', 'facility': 'Hospital Universitario Dr. Jose E. Gonzalez', 'geoPoint': {'lat': 25.68435, 'lon': -100.31721}}], 'overallOfficials': [{'name': 'Jose A Ontiveros Sanchez de la Barquera, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital Universitario Dr. Jose E. Gonzalez'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Universitario Dr. Jose E. Gonzalez', 'class': 'OTHER'}, 'collaborators': [{'name': 'Instituto de Información e Investigación en Salud Mental A. C.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'José Alfonso Ontiveros Sánchez De la Barquera', 'investigatorAffiliation': 'Hospital Universitario Dr. Jose E. Gonzalez'}}}}