Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-31 @ 7:49 PM
Study NCT ID:
NCT03187093
Status:
UNKNOWN
Last Update Posted:
2019-01-10
First Post:
2017-06-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cognitive Dysfunction in MDD Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000078784', 'term': 'Vortioxetine'}, {'id': 'D000089983', 'term': 'Escitalopram'}], 'ancestors': [{'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011437', 'term': 'Propylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D001572', 'term': 'Benzofurans'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2019-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-01-08', 'studyFirstSubmitDate': '2017-06-01', 'studyFirstSubmitQcDate': '2017-06-13', 'lastUpdatePostDateStruct': {'date': '2019-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline to week 8 in Sheehan Disability Scale', 'timeFrame': 'Baseline to Week 8'}], 'secondaryOutcomes': [{'measure': 'Change from baseline to week 8 in MADRS', 'timeFrame': 'Baseline to Week 8'}, {'measure': 'Change from baseline to week 8 in PHQ-9', 'timeFrame': 'Baseline to Week 8'}, {'measure': 'Change from baseline to week 8 in CGI-S', 'timeFrame': 'Baseline to Week 8'}, {'measure': 'Change from baseline to week 8 in PDQ-5-D', 'timeFrame': 'Baseline to Week 8'}, {'measure': 'Change from baseline to week 8 in RAVLT', 'timeFrame': 'Baseline to Week 8'}, {'measure': 'Change from baseline to week 8 in TMT-B', 'timeFrame': 'Baseline to Week 8'}, {'measure': 'Change from baseline to week 8 in DSST', 'timeFrame': 'Baseline to Week 8'}, {'measure': 'Change from baseline to week 8 in plasma levels of IGF-1', 'timeFrame': 'Baseline to Week 8'}, {'measure': 'Change from baseline to week 8 in plasma levels of BDNF', 'timeFrame': 'Baseline to Week 8'}, {'measure': 'Change from baseline to week 8 in plasma levels of CRP', 'timeFrame': 'Baseline to Week 8'}, {'measure': 'Change from baseline to week 8 in plasma levels of cortisol', 'timeFrame': 'Baseline to Week 8'}, {'measure': 'Change from baseline to week 8 in plasma levels of ACTH', 'timeFrame': 'Baseline to Week 8'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MDD', 'Vortioxetine', 'Cognitive dysfunction', 'IGF-1', 'BDNF', 'Functioning'], 'conditions': ['Major Depressive Disorder']}, 'referencesModule': {'references': [{'pmid': '32384884', 'type': 'DERIVED', 'citation': 'Levada OA, Troyan AS, Pinchuk IY. Serum insulin-like growth factor-1 as a potential marker for MDD diagnosis, its clinical characteristics, and treatment efficacy validation: data from an open-label vortioxetine study. BMC Psychiatry. 2020 May 8;20(1):208. doi: 10.1186/s12888-020-02636-7.'}]}, 'descriptionModule': {'briefSummary': 'Major Depressive Disorder (MDD) is one of the most prevalent mental diagnosis within the worldwide population. Although there is evidence about relationship between MDD and cognitive dysfunction, still the correlations between biomarkers and the severity of the disorder or the level of cognitive dysfunction need further research. Therefore, the aim of the study is to determine such relationships in Ukrainian population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Outpatient 18 to 65 years of age\n* Meets DSM-5 criteria for MDD\n* Depressive episode duration ≥ 2 months\n* The participant has MARDS total score ≥ 7\n* Free of psychotropic medications for at least 5 half-lives before baseline\n* Fluent in Russian/Ukrainian\n\nExclusion Criteria:\n\n* Current diagnosis or history of manic/hypomanic episode\n* Any other psychiatric diagnosis that is considered the primary diagnosis\n* Any significant personality disorder diagnosis\n* High suicidal risk, defined by clinician judgment\n* Substance dependence/abuse in the past year\n* Significant neurological disorders, head trauma, or other unstable medical conditions\n* History of endocrinological diseases\n* Pregnant or breastfeeding\n* Psychosis in the current episode\n* High risk for hypomanic switch\n* Cognitive or language impairment of such severity as to adversely affect the performance of tests'}, 'identificationModule': {'nctId': 'NCT03187093', 'briefTitle': 'Cognitive Dysfunction in MDD Patients', 'organization': {'class': 'OTHER', 'fullName': 'State Institution, Zaporizhzhia Medical Academy of Post-Graduate Education Ministry of Health of Ukraine'}, 'officialTitle': 'Cognitive Dysfunction in Patients With Major Depressive Disorder, Clinical Peculiarities, Biological Markers, and Treatment Efficacy', 'orgStudyIdInfo': {'id': '11031215'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Vortioxetine', 'interventionNames': ['Drug: Vortioxetine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Escitalopram', 'interventionNames': ['Drug: Escitalopram']}], 'interventions': [{'name': 'Vortioxetine', 'type': 'DRUG', 'otherNames': ['Brintellix', 'Trintellix'], 'description': '10-20 mg once daily for 8 weeks', 'armGroupLabels': ['Vortioxetine']}, {'name': 'Escitalopram', 'type': 'DRUG', 'description': '10-20 mg once daily for 8 weeks', 'armGroupLabels': ['Escitalopram']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69096', 'city': 'Zaporizhzhia', 'status': 'RECRUITING', 'country': 'Ukraine', 'contacts': [{'name': 'Alexandra Troyan, MD', 'role': 'CONTACT', 'email': 'troian@zmapo.edu.ua', 'phone': '+380673287519'}], 'facility': 'State Institution "Zaporizhzhia Medical Academy of Postgraduate Education Ministry of Health of Ukraine"', 'geoPoint': {'lat': 47.15214, 'lon': 35.74246}}], 'centralContacts': [{'name': 'Oleg A. Levada, MD, ScD', 'role': 'CONTACT', 'email': 'olevada@zmapo.edu.ua', 'phone': '+380672623972'}, {'name': 'Alexandra Troyan', 'role': 'CONTACT', 'email': 'troian@zmapo.edu.ua', 'phone': '+380673287519'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oleg Levada', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD, ScD (psychiatry), PhD (neurology), Psychiatry course chief', 'investigatorFullName': 'Oleg Levada', 'investigatorAffiliation': 'State Institution, Zaporizhzhia Medical Academy of Post-Graduate Education Ministry of Health of Ukraine'}}}}