Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-25 @ 9:30 PM
Study NCT ID:
NCT02942251
Status:
UNKNOWN
Last Update Posted:
2016-10-26
First Post:
2016-10-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Relapse Predicting Model for First Episode Depression
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': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D014181', 'term': 'Transplantation Immunology'}, {'id': 'D015897', 'term': 'Comorbidity'}, {'id': 'D013812', 'term': 'Therapeutics'}], 'ancestors': [{'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D013678', 'term': 'Technology, Pharmaceutical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D055633', 'term': 'Immune System Phenomena'}, {'id': 'D015981', 'term': 'Epidemiologic Factors'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-10-25', 'studyFirstSubmitDate': '2016-10-20', 'studyFirstSubmitQcDate': '2016-10-20', 'lastUpdatePostDateStruct': {'date': '2016-10-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-10-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HAM-D total score', 'timeFrame': '12 weeks', 'description': 'The change from baseline to end of study (EOS) in HAM-D total score'}], 'secondaryOutcomes': [{'measure': 'Time to relapse', 'timeFrame': '12 months', 'description': 'The time to new intervention for an emerging mood episode'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['MDD', 'big data analytics'], 'conditions': ['Major Depressive Disorders']}, 'descriptionModule': {'briefSummary': 'Major depressive depression(MDD) is an severe public mental disorders. The purpose of current study is using big data analysis based on clinical features and immunochemistry to investigate and establish an relapse predict model for patients with first episode MDD.', 'detailedDescription': 'Major depressive depression(MDD) is an severe public mental disorders. The purpose of current study is using big data analysis based on clinical features and immunochemistry to investigate and establish an relapse predict model for patients with first episode MDD.\n\nThis study includes two steps. Step 1: Big data analysis based on the clinical features and immunochemical figures of 30000 patients with first episode MDD will be conducted to construct a relapse predict model.\n\nStep 2: 300 patients with first episode MDD will be recruited in this step. Physicians prefer to give corresponding treatment recommendation based on the predictive factors to verify this relapse model.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age from 18 to 65 years old;\n* Han Chinese;\n* Outpatient and inpatient patients;\n* Patients met Diagnostic and Statistical Manual of Mental Disorders(DSM-IV-TR) criteria of bipolar I or II disorder, currently depressed, ascertained with the Mini International Neuropsychiatric Interview (MINI)\n* Hamilton Depression Scale(HAM-D) total score≥17, HAM-D item 1 (depressed mood) score≥2, and Young Mania Rating Scale(YMRS) total score≤10 at baseline;\n* Written informed consent was given;\n* Junior high school education and above, with enough audio-visual ability to accomplish the visits;\n* Normally resident in one country and had a residential address, able to follow-up.\n\nExclusion Criteria:\n\n* Bipolar disorder rapid cycling or mixed episode;\n* Experienced DSM-IV-TR axis I disorders in the 6 months prior to randomization;\n* Severe personality disorder, metal retardation, anorexia/bulimia nervosa;\n* Actively suicide ascertained by research psychiatrist or HAM-D item 3 score≥3(suicidality);\n* Female patients who were pregnant, planning to be pregnant or breast feeding;\n* Severe medical or neurological problems.'}, 'identificationModule': {'nctId': 'NCT02942251', 'acronym': 'RPM-FED', 'briefTitle': 'Relapse Predicting Model for First Episode Depression', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Mental Health Center'}, 'officialTitle': 'The Study of Relapse Predicting Model for First Episode Depression: Big Data Analysis Based on Clinical Features and Immunochemistry', 'orgStudyIdInfo': {'id': 'Pending'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Clinical features and medication', 'description': 'A group patients with significant high risk of clinical features and medications.', 'interventionNames': ['Other: Clinical features and medication']}, {'type': 'EXPERIMENTAL', 'label': 'Psycho-social', 'description': 'A group patients with significant high risk of psycho-social problems.', 'interventionNames': ['Other: Psycho-social']}, {'type': 'EXPERIMENTAL', 'label': 'immunology', 'description': 'A group patients with significant high risk of immune disturbance.', 'interventionNames': ['Other: immunology']}, {'type': 'EXPERIMENTAL', 'label': 'Laboratory abnormality', 'description': 'A group patients with significant high risk of Laboratory abnormalities.', 'interventionNames': ['Other: Laboratory abnormality']}, {'type': 'EXPERIMENTAL', 'label': 'Comorbidity', 'description': 'A group patients with physical or mental disorders comorbidities.', 'interventionNames': ['Other: Comorbidity']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment as usual', 'description': 'Control group.', 'interventionNames': ['Other: Treatment as usual']}], 'interventions': [{'name': 'Clinical features and medication', 'type': 'OTHER', 'description': 'This group will be suggested to take optimize treatment according to Chinese treatment guidelines.', 'armGroupLabels': ['Clinical features and medication']}, {'name': 'Psycho-social', 'type': 'OTHER', 'description': 'This group will be suggested to add on psychotherapy on medical treatment.', 'armGroupLabels': ['Psycho-social']}, {'name': 'immunology', 'type': 'OTHER', 'description': 'This group will be suggested to add on Omega-3 polyunsaturated fatty acid(PUFAs) on medical treatment.', 'armGroupLabels': ['immunology']}, {'name': 'Laboratory abnormality', 'type': 'OTHER', 'description': 'This group will be suggested to more safety antidepressants.', 'armGroupLabels': ['Laboratory abnormality']}, {'name': 'Comorbidity', 'type': 'OTHER', 'description': 'This group will be suggested to treat their comorbidities as well as treat MDD.', 'armGroupLabels': ['Comorbidity']}, {'name': 'Treatment as usual', 'type': 'OTHER', 'otherNames': ['Treatment as usual(TAU)'], 'description': 'Patients will accept routine treatments based on psychiatrist experience, not based on the relapse predict model.', 'armGroupLabels': ['Treatment as usual']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Jun Chen, M.D., Ph.D', 'role': 'CONTACT', 'email': 'doctorcj2010@gmail.com', 'phone': '021-34773367'}, {'name': 'Jia Huang, Master', 'role': 'CONTACT', 'email': 'kittyhj_2000@aliyun.com', 'phone': '13750892815'}], 'overallOfficials': [{'name': 'Jun Chen, M.D., Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai Mental Health Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Mental Health Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}