Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2026-02-21 @ 10:08 PM
Study NCT ID:
NCT02023567
Status:
UNKNOWN
Last Update Posted:
2016-05-20
First Post:
2013-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Objective Diagnostic Markers and Personalized Intervention in MDD Patients
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017367', 'term': 'Selective Serotonin Reuptake Inhibitors'}], 'ancestors': [{'id': 'D014179', 'term': 'Neurotransmitter Uptake Inhibitors'}, {'id': 'D049990', 'term': 'Membrane Transport Modulators'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D018377', 'term': 'Neurotransmitter Agents'}, {'id': 'D018490', 'term': 'Serotonin Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2400}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-05-18', 'studyFirstSubmitDate': '2013-12-15', 'studyFirstSubmitQcDate': '2013-12-23', 'lastUpdatePostDateStruct': {'date': '2016-05-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The changes of HAMD total score at 8 weeks from baseline', 'timeFrame': 'week 0,2,4,8', 'description': 'The scores are assessed at 0,2,4,8 weeks since the medication begins for MDD group'}], 'secondaryOutcomes': [{'measure': 'The changes of HAMA total score at 8 weeks from baseline', 'timeFrame': 'week 0,2,4,8', 'description': 'The scores are assessment at 0,2,4,8 weeks since the medication begins for MDD group'}, {'measure': 'The change of CGI score at 8 weeks from baseline', 'timeFrame': 'week 0,2,4,8', 'description': 'The scores are assessment at 0,2,4,8 weeks since the medication begins for MDD group'}, {'measure': 'The prognosis after the intervention', 'timeFrame': 'Up to 2 years'}, {'measure': 'Number of participants with serious and non-serious adverse events', 'timeFrame': 'Up to two years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Depressive Disorder, Major']}, 'referencesModule': {'references': [{'pmid': '39433132', 'type': 'DERIVED', 'citation': 'Cui F, Liu Q, Lv X, Tian H, Wei J, Zhang K, Zhu G, Chen Q, Wang G, Wang X, Zhang N, Huang Y, Si T, Yu X. Effect of childhood trauma on cognitive function in individuals with major depressive disorder and healthy controls. J Affect Disord. 2025 Feb 15;371:196-204. doi: 10.1016/j.jad.2024.10.059. Epub 2024 Oct 19.'}, {'pmid': '37657624', 'type': 'DERIVED', 'citation': 'Lin J, Li JT, Kong L, Liu Q, Lv X, Wang G, Wei J, Zhu G, Chen Q, Tian H, Zhang K, Wang X, Zhang N, Yu X, Si T, Su YA. Proinflammatory phenotype in major depressive disorder with adulthood adversity: In line with social signal transduction theory of depression. J Affect Disord. 2023 Nov 15;341:275-282. doi: 10.1016/j.jad.2023.08.104. Epub 2023 Aug 30.'}, {'pmid': '34985583', 'type': 'DERIVED', 'citation': 'Lin J, Su Y, Lv X, Liu Q, Wang G, Wei J, Zhu G, Chen Q, Tian H, Zhang K, Wang X, Zhang N, Yan H, Wang Y, Yu X, Si T. Childhood adversity, adulthood adversity and suicidal ideation in Chinese patients with major depressive disorder: in line with stress sensitization. Eur Arch Psychiatry Clin Neurosci. 2022 Aug;272(5):887-896. doi: 10.1007/s00406-021-01375-4. Epub 2022 Jan 5.'}, {'pmid': '33874911', 'type': 'DERIVED', 'citation': 'Cui F, Liu Q, Lv X, Leonhart R, Tian H, Wei J, Zhang K, Zhu G, Chen Q, Wang G, Wang X, Zhang N, Huang Y, Si T, Yu X. Severe sleep disturbance is associated with executive function impairment in patients with first-episode, treatment-naive major depressive disorders. BMC Psychiatry. 2021 Apr 19;21(1):198. doi: 10.1186/s12888-021-03194-2.'}, {'pmid': '31959583', 'type': 'DERIVED', 'citation': 'Lin J, Su Y, Lv X, Liu Q, Wang G, Wei J, Zhu G, Chen Q, Tian H, Zhang K, Wang X, Zhang N, Wang Y, Yu X, Si T. Perceived stressfulness mediates the effects of subjective social support and negative coping style on suicide risk in Chinese patients with major depressive disorder. J Affect Disord. 2020 Mar 15;265:32-38. doi: 10.1016/j.jad.2020.01.026. Epub 2020 Jan 10.'}, {'pmid': '29664050', 'type': 'DERIVED', 'citation': 'Lin JY, Huang Y, Su YA, Yu X, Lyu XZ, Liu Q, Si TM. Association between Perceived Stressfulness of Stressful Life Events and the Suicidal Risk in Chinese Patients with Major Depressive Disorder. Chin Med J (Engl). 2018 Apr 20;131(8):912-919. doi: 10.4103/0366-6999.229898.'}, {'pmid': '27422150', 'type': 'DERIVED', 'citation': 'Lv X, Si T, Wang G, Wang H, Liu Q, Hu C, Wang J, Su Y, Huang Y, Jiang H, Yu X. The establishment of the objective diagnostic markers and personalized medical intervention in patients with major depressive disorder: rationale and protocol. BMC Psychiatry. 2016 Jul 15;16:240. doi: 10.1186/s12888-016-0953-z.'}]}, 'descriptionModule': {'briefSummary': 'Major depressive disorder (MDD) is one of the most common psychiatric disorders, with high recurrence rate, suicide rate and disability rate. It\'s reported that the global burden caused by MDD will be up to the second rank among all the disease burdens by 2020. China is also confronted with the daunting challenges against MDD. It\'s assessed that the monthly incidence of MDD is 6.1%, non-hospitalizing rate reaches up to 92% and the non-treatment rate is approximate 95%. However, to date, the pathogenesis of MDD is obscure and the current therapies don\'t work well. Therefore, it\'s urgent and critical to elucidate the pathogenesis of MDD, to develop early diagnostic criteria and effective intervention in MDD. Considering the diversity of weights on genetic factor and environmental factor in MDD, in this project, the investigators aim firstly to explore the effect of "genetic-environmental interaction"on the pathogeny of MDD for classifying MDD into "genetic type", "environmental type" and "others" based on a case-control study. We next conduct the neurobiological, neurocognitive and psycho-behavioral assessments among MDD, schizophrenia and healthy groups to screen the salient endophenotypes for establishing the diagnostic models of MDD . The investigators further analyse the changes of these indicators after 8 weeks\'medication to select the potential predictors for therapeutic evaluations and interventional options in MDD patients. Finally, the investigators continue a 2-year follow-up study to test and verify the predictors of prognosis in MDD patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': '1. For MDD group:\n\n Inclusion criteria:\n * Age between 18-55, male or female;\n * The diagnosis of MDD consistent with DSM-IV (M.I.N.I)\n * First-episode or relapsed;\n * Certain ability of reading and writing to complete the questionnaire survey and psychological assessment.\n * All participants provide written confirmation of informed consent prior to engaging the study protocol.\n\n Exclusion criteria:\n * Current psychopathology or a history of neurologic conditions, including alcohol/substances dependence, the diagnosis of cognition impairment;\n * Severe somatic diseases, such as severe cardio-cerebral vascular diseases, respiratory diseases, liver diseases, kidney diseases, or malignant tumors;\n * Not signed the informed consent;\n * Been engaging other studies.\n2. For Healthy control group\n\nInclusion criteria:\n\n* age between 18 and 55 years at the time of enrollment;\n* providing written confirmation of informed consent prior to engaging the study.\n\nExclusion criteria:\n\n* lifetime or current diagnosis of any mental diseases;\n* severe somatic diseases, such as severe cardio-cerebral vascular diseases, respiratory diseases, liver diseases, kidney diseases, or malignant tumors;\n* not signed the informed consent;\n* been engaging other studies.'}, 'identificationModule': {'nctId': 'NCT02023567', 'briefTitle': 'Objective Diagnostic Markers and Personalized Intervention in MDD Patients', 'organization': {'class': 'OTHER', 'fullName': 'Peking University'}, 'officialTitle': 'The Establishment of the Objective Diagnostic Markers and Personalized Medical Intervention in Patients With Major Depressive Disorders (MDD)', 'orgStudyIdInfo': {'id': '2013CB531305'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MDD group', 'description': 'Drugs: SSRIs fluoxertine hydrochloride (20- 60m/day),paroxetine hydrochloride (20- 60m/day),sertraline hydrochloride (50- 200m/day),citalopram (20-60m/day), escitalopram (10-20mg/day),fluvoxamine (50-300mg/day)', 'interventionNames': ['Drug: SSRIs']}, {'type': 'NO_INTERVENTION', 'label': 'Healthy controls', 'description': 'This group just receive baseline evaluation and did not receive any intervention.'}], 'interventions': [{'name': 'SSRIs', 'type': 'DRUG', 'otherNames': ['selective serotonin reuptake inhibitors'], 'description': 'fluoxertine hydrochloride 20-60mg/day, paroxetine hydrochloride 20-60mg/day, sertraline hydrochloride 50-200mg/day, citalopram 20-60mg/day, escitalopram 10-20mg/day, fluvoxamine 50-300mg/day', 'armGroupLabels': ['MDD group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Gang Wang', 'role': 'CONTACT', 'email': 'gangwangdoc@gmail.com', 'phone': '86-13911695727'}, {'name': 'Changqing Hu', 'role': 'CONTACT', 'email': 'coannhu@126.com', 'phone': '86-13661106500'}], 'facility': 'Beijing Anding Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'China', 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qi Liu', 'role': 'CONTACT', 'email': 'liu_qee@sina.com', 'phone': '86-10-82801955', 'phoneExt': '86-13671013073'}], 'facility': 'Peking University Sixth Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Shijiazhuang', 'state': 'Hebei', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'China', 'facility': 'Hebei Medical University First Hospital', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}, {'city': 'Dalian', 'state': 'Liaoning', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'China', 'facility': "Dalian Seventh People's Hospital", 'geoPoint': {'lat': 38.91222, 'lon': 121.60222}}, {'city': 'Shenyang', 'state': 'Liaoning', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'China', 'facility': 'First Hospital of China Medical University', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'city': 'Taiyuan', 'state': 'Shanxi', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'China', 'facility': 'First Hospital of Shanxi Medical University', 'geoPoint': {'lat': 37.86944, 'lon': 112.56028}}, {'city': 'Tianjin', 'state': 'Tianjin Municipality', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'China', 'facility': 'Tianjin Anding Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'city': 'Tianjin', 'state': 'Tianjin Municipality', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'China', 'facility': 'Tianjin Medical University General Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'centralContacts': [{'name': 'Tianmei Si, MD', 'role': 'CONTACT', 'email': 'si.tian-mei@163.com', 'phone': '86-10-62723748', 'phoneExt': '86-139109877'}, {'name': 'Gang Wang, MD', 'role': 'CONTACT', 'email': 'gangwangdoc@mail1.bbuser.com'}], 'overallOfficials': [{'name': 'Xin Yu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University Sixth Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'After enrollment completion,we will decided whether share data or not.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Capital Medical University', 'class': 'OTHER'}, {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, {'name': 'Tianjin Medical University General Hospital', 'class': 'OTHER'}, {'name': 'Tianjin Anding Hospital', 'class': 'OTHER'}, {'name': 'The First Hospital of Hebei Medical University', 'class': 'OTHER'}, {'name': 'First Hospital of China Medical University', 'class': 'OTHER'}, {'name': "Dalian Seventh People's Hospital", 'class': 'OTHER'}, {'name': 'The First Affiliated Hospital of Shanxi Medical University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Xin Yu', 'investigatorAffiliation': 'Peking University'}}}}