Viewing Study NCT02682004


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Study NCT ID: NCT02682004
Status: COMPLETED
Last Update Posted: 2022-03-15
First Post: 2016-02-10
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Serotonin, Leptin and Adiponectin Level in Patients With Postpartum Depression: Controlled Study
Sponsor:
Organization:

Raw JSON

{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019052', 'term': 'Depression, Postpartum'}], 'ancestors': [{'id': 'D011644', 'term': 'Puerperal Disorders'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020738', 'term': 'Leptin'}, {'id': 'D012701', 'term': 'Serotonin'}], 'ancestors': [{'id': 'D054392', 'term': 'Adipokines'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D014363', 'term': 'Tryptamines'}, {'id': 'D015306', 'term': 'Biogenic Monoamines'}, {'id': 'D001679', 'term': 'Biogenic Amines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D012898', 'term': 'Autacoids'}, {'id': 'D018836', 'term': 'Inflammation Mediators'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-13', 'studyFirstSubmitDate': '2016-02-10', 'studyFirstSubmitQcDate': '2016-02-12', 'lastUpdatePostDateStruct': {'date': '2022-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-02-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood level (ng/ml) ELİSA', 'timeFrame': '1 month'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Postpartum Depression']}, 'referencesModule': {'references': [{'pmid': '25469244', 'type': 'RESULT', 'citation': 'Hu Y, Dong X, Chen J. Adiponectin and depression: A meta-analysis. Biomed Rep. 2015 Jan;3(1):38-42. doi: 10.3892/br.2014.372. Epub 2014 Oct 16.'}, {'pmid': '19427131', 'type': 'RESULT', 'citation': 'Skalkidou A, Sylven SM, Papadopoulos FC, Olovsson M, Larsson A, Sundstrom-Poromaa I. Risk of postpartum depression in association with serum leptin and interleukin-6 levels at delivery: a nested case-control study within the UPPSAT cohort. Psychoneuroendocrinology. 2009 Oct;34(9):1329-37. doi: 10.1016/j.psyneuen.2009.04.003. Epub 2009 May 7.'}, {'pmid': '26748249', 'type': 'RESULT', 'citation': 'Mansur RB, Rizzo LB, Santos CM, Asevedo E, Cunha GR, Noto MN, Pedrini M, Zeni M, Cordeiro Q, McIntyre RS, Brietzke E. Adipokines, metabolic dysfunction and illness course in bipolar disorder. J Psychiatr Res. 2016 Mar;74:63-9. doi: 10.1016/j.jpsychires.2015.12.003. Epub 2015 Dec 12.'}], 'seeAlsoLinks': [{'url': 'http://www.ncbi.nlm.nih.gov/pubmed/25469244', 'label': 'Related Info'}, {'url': 'http://www.ncbi.nlm.nih.gov/pubmed/?term=risk+of+postpartum+depression+in+association+with+serum+leptin+and', 'label': 'Related Info'}, {'url': 'http://www.ncbi.nlm.nih.gov/pubmed/26748249', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'After vaginal delivery, all of the participants will evaluate by using Edinburg depression scale and venous blood sample will obtain. Postpartum depression will consider the result of scale 13 and above according to Turkhish translate. Then leptin, adiponectin and serotonin level will compare between depressed and nondepressed women.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'According to Edinburg depression scale womenn who taken 13 point and above.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All women who gave birth\n\nExclusion Criteria:\n\n* women with previously diagnosed depression and any psychiatric disorders\n* women with previously take antidepressan and antipshycothic\n* women giving birth to children with anomalies\n* women with undertake surgery for peripartum hemorrhage'}, 'identificationModule': {'nctId': 'NCT02682004', 'briefTitle': 'Serotonin, Leptin and Adiponectin Level in Patients With Postpartum Depression: Controlled Study', 'organization': {'class': 'OTHER', 'fullName': 'Zeynep Kamil Maternity and Pediatric Research and Training Hospital'}, 'officialTitle': 'Serotonin, Leptin and Adiponectin Level in Patients With Postpartum Depression: Controlled Study', 'orgStudyIdInfo': {'id': '51'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Women with postpartum depression', 'interventionNames': ['Other: leptin, serotonin and adiponectin level']}, {'label': 'Women without postpartum depression', 'interventionNames': ['Other: leptin,serotonin, adiponectin level']}], 'interventions': [{'name': 'leptin, serotonin and adiponectin level', 'type': 'OTHER', 'armGroupLabels': ['Women with postpartum depression']}, {'name': 'leptin,serotonin, adiponectin level', 'type': 'OTHER', 'armGroupLabels': ['Women without postpartum depression']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34668', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Zeynep Kamil Maternity and Pediatric Research and Training Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zeynep Kamil Maternity and Pediatric Research and Training Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Mehmet Baki Senturk', 'investigatorAffiliation': 'Zeynep Kamil Maternity and Pediatric Research and Training Hospital'}}}}