Ignite Creation Date:
2025-12-24 @ 4:39 PM
Ignite Modification Date:
2025-12-24 @ 4:39 PM
Study NCT ID:
NCT04209166
Status:
UNKNOWN
Last Update Posted:
2019-12-23
First Post:
2019-12-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Individualized Diagnosis and Treatment for Major Depressive Disorder With Atypical Features
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'}, {'id': 'D000068760', 'term': 'Serotonin and Noradrenaline Reuptake Inhibitors'}, {'id': 'D012701', 'term': 'Serotonin'}], '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'}, {'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'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 780}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-08-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2022-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-12-20', 'studyFirstSubmitDate': '2019-12-16', 'studyFirstSubmitQcDate': '2019-12-20', 'lastUpdatePostDateStruct': {'date': '2019-12-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'remission of acute phase', 'timeFrame': '12th week', 'description': "scored 7 or lower on the Hamilton's Depression Scale with 24 items"}, {'measure': 'switch rate', 'timeFrame': '4th year', 'description': 'the rate of patients who switch from depression to mania or hypomania during 4-year follow-up'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Major Depressive Disorder']}, 'referencesModule': {'references': [{'pmid': '37143128', 'type': 'DERIVED', 'citation': 'Zhou R, Zhang H, He S, Li Y, Xu G, Huang J, Wang H, Wang Q, Li B, Wang X, Chen N, Li F, Li X, Liu M, Peng D. A Study of Individualized Diagnosis and Treatment for Depression with Atypical Features (iDoT-AFD): study protocol for a randomized clinical trial and prognosis study. Trials. 2023 May 4;24(1):308. doi: 10.1186/s13063-023-07317-w.'}]}, 'descriptionModule': {'briefSummary': 'The lifetime prevalence of major depressive disorder (MDD) is 10%\\~20%. Worldwide, nearly 340 million individuals have suffered the torture of depression. World Health Organization has reported that MDD would become the most serious global burden of disease and eventually turn into a public health problem in 2030. Varied clinical symptoms, inappropriate treatment, unclear pathogenesis, and lack of recurrent risk early-warning predictors cause a series of clinical problems, such as low diagnostic rate, low effective treatment rate, and high recurrent rate. Hence, this study aims to search multidimensional markers for early diagnosis of MDD, to establish optimized personalized therapy, and to explore sensitive recurrence predictors.\n\nBased on the criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), MDD is subdivided into eight different clinical specifiers, one of which the incident rate of MDD with atypical features reaches 30%\\~38%. However, there is still a lack of meta-evidence for the clinical treatment strategy in MDD with atypical features. And 45.4 percentage of MDD with atypical features convert to bipolar disorder. Therefore, this study will focus on three issues about what\'s the objective endophenotype in MDD with atypical features, how to select appropriate personalized treatment for MDD with atypical features, what\'s the predictive biomarker of conversion to bipolar disorder.\n\nBased on the investigators\' previous findings, this study will investigate adult depression at a cross-sectional study and a prospective cohort study. Multivariate informatics analysis was performed from three research dimensions (cognitive neuropsychology, metabonomics, and multimodal neuroimaging), including atypical features, "cold/hot" cognition assessment, KP (kynurenine pathway) metabolomics and inflammatory factors, multimodal MRI robust property. Referring guidelines for the diagnosis and treatment of depression and evidence-based medicine evidence, MDD with atypical features are divided into f groups (antidepressants, antidepressants+mood stabilizers, mood stabilizers, treat as usual). Then, the investigators perform follow-up to verify optimized treatment strategies and to explore risk factors of conversion from MDD with atypical features to bipolar disorder. Furthermore, this study performs correlation analysis to analyze cross-omics data, weight coefficient analysis to analyze multidimensional indexes, clustering analysis to analyze multivariate bio-information data, and artificial intelligence technologies (such as pattern recognition, and machine learning) to realize the transformation from medical data to practical transformation. Eventually, this study builds three specific models (the multidimensional early diagnosis models for MDD with atypical features, the optimized personalized therapy model, and the recurrence and conversion risk early-warning model), which form the integrated intelligent platform for multidimensional diagnosis, personalized treatment, recovery management of MDD with atypical features.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. 16-60 years old;\n2. Meeting with the criteria of major depressive disorder in the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5;\n3. Scored 20 or higher on the Hamilton's Depression Scale with 24 items (HAMD-24);\n4. With enough audio-visual ability and comprehensive ability to accomplish the visits;\n5. Be necessary and suitable to accept the treatment of antidepressants;\n6. Scored less than 14 on Hamilton's Anxiety Scale (HAMA) and scored less than 14 on the Hypomania Symptom Checklist-32 (HCL-32);\n7. With 2 or more atypical symptoms including significant weight gain or increase in appetite, hypersomnia, leaden paralysis, and a long-standing pattern of interpersonal rejection sensitivity that results in significant social or occupational impairment.\n\nExclusion Criteria:\n\n1. Severe medical or neurological problems;\n2. Previous mania or hypomania episodes;\n3. Female patients who are pregnant, planning to be pregnant or breastfeeding;\n4. Actively suicide ascertained by research psychiatrist or 3rd item of HAMD scored≥3(suicidality);\n5. Had ECT, MECT or rTMS in the past 6 months;\n6. Experienced severe personality disorder, mental retardation, anorexia/bulimia nervosa."}, 'identificationModule': {'nctId': 'NCT04209166', 'briefTitle': 'A Study of Individualized Diagnosis and Treatment for Major Depressive Disorder With Atypical Features', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Mental Health Center'}, 'officialTitle': 'A Study of Individualized Diagnosis and Treatment for Major Depressive Disorder With Atypical Features', 'orgStudyIdInfo': {'id': 'CRC2018ZD05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FAD', 'description': 'the first-episode major depressive disorder with atypical feature', 'interventionNames': ['Drug: SSRIs/SNRIs (Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors)', 'Drug: SSRIs/SNRIs+Mood Stabilizer', 'Drug: SSRIs/SNRIs+Quetiapine', 'Drug: Usual Treatment']}, {'type': 'EXPERIMENTAL', 'label': 'RAD', 'description': 'the recurrent major depressive disorder with atypical feature who have been medication-free for no less than 2 weeks', 'interventionNames': ['Drug: SSRIs/SNRIs (Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors)', 'Drug: SSRIs/SNRIs+Mood Stabilizer', 'Drug: SSRIs/SNRIs+Quetiapine', 'Drug: Usual Treatment']}, {'type': 'NO_INTERVENTION', 'label': 'BD', 'description': 'the depressive episode of bipolar disorder'}, {'type': 'NO_INTERVENTION', 'label': 'HC', 'description': 'healthy control'}], 'interventions': [{'name': 'SSRIs/SNRIs (Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors)', 'type': 'DRUG', 'description': 'Patients will be treated with Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors.', 'armGroupLabels': ['FAD', 'RAD']}, {'name': 'SSRIs/SNRIs+Mood Stabilizer', 'type': 'DRUG', 'description': 'Patients will be treated with Mood Stabilizer combined with Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors.', 'armGroupLabels': ['FAD', 'RAD']}, {'name': 'SSRIs/SNRIs+Quetiapine', 'type': 'DRUG', 'description': 'Patients will be treated with Quetiapine combined with Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors.', 'armGroupLabels': ['FAD', 'RAD']}, {'name': 'Usual Treatment', 'type': 'DRUG', 'description': "Patients' treatment will be decided by the clinical doctor.", 'armGroupLabels': ['FAD', 'RAD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510000', 'city': 'Guanzhou', 'state': 'Guangdong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Guiyun Xu, MD', 'role': 'CONTACT', 'email': '13650774898@163.com', 'phone': '18922165291'}], 'facility': 'Guangzhou Psychiatric Hospital', 'geoPoint': {'lat': 23.06828, 'lon': 113.37117}}, {'zip': '430000', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yi Li, MD', 'role': 'CONTACT', 'email': 'psylee@163.com', 'phone': '13554013182'}], 'facility': 'Wuhan Mental Health Center', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '116000', 'city': 'Dalian', 'state': 'Liaoning', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shoufu Xie, MD', 'role': 'CONTACT', 'phone': '13998622066'}], 'facility': "Dalian Seventh People's Hospital", 'geoPoint': {'lat': 38.91222, 'lon': 121.60222}}, {'zip': '200030', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Daihui Peng, M.D.,Ph.D.', 'role': 'CONTACT', 'email': 'pdhsh@126.com', 'phone': '18017311136'}], 'facility': 'Shanghai Mental Health Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '710000', 'city': 'Xian', 'state': 'Shanxi', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Huaning Wang, MD', 'role': 'CONTACT', 'email': '13609161341@163.com', 'phone': '13609161341'}], 'facility': 'Fourth Military Medical University'}], 'centralContacts': [{'name': 'Daihui Peng, MD. PhD.', 'role': 'CONTACT', 'email': 'pdhsh@126.com', 'phone': '18017311136'}], 'overallOfficials': [{'name': 'Daihui Peng, MD. PhD.', 'role': 'STUDY_CHAIR', 'affiliation': 'Shanghai Mental Health Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Mental Health Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Air Force Military Medical University, China', 'class': 'OTHER'}, {'name': 'Guangzhou Psychiatric Hospital', 'class': 'OTHER_GOV'}, {'name': "Dalian Seventh People's Hospital", 'class': 'OTHER'}, {'name': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'class': 'OTHER'}, {'name': 'Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}