Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2026-02-22 @ 9:37 AM
Study NCT ID:
NCT02723903
Status:
UNKNOWN
Last Update Posted:
2020-03-04
First Post:
2016-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hierarchical Treatment Based on Somatization Symptom Checklist
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017566', 'term': 'Microvascular Angina'}], 'ancestors': [{'id': 'D000787', 'term': 'Angina Pectoris'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000851', 'term': 'flupentixol, melitracen drug combination'}, {'id': 'D005473', 'term': 'Fluoxetine'}], 'ancestors': [{'id': 'D011437', 'term': 'Propylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-02', 'studyFirstSubmitDate': '2016-02-15', 'studyFirstSubmitQcDate': '2016-03-24', 'lastUpdatePostDateStruct': {'date': '2020-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The efficacy of somatization symptom score', 'timeFrame': '2 weeks after the first visit', 'description': 'observe the efficacy by the score of somatic symptom scale (SSS), Patient Health Questionnaire (PHQ-9), Generalized Anxiety Disorder 7-items (GAD-7)'}], 'secondaryOutcomes': [{'measure': 'scale chest discomfort', 'timeFrame': '2 weeks after the first visit', 'description': 'observe if the chest discomfort no change, alleviate or disappear'}, {'measure': 'The efficacy of Patient Health Questionnaire', 'timeFrame': '2 weeks after the first visit', 'description': 'observe the efficacy by the score of Patient Health Questionnaire (PHQ-9)'}, {'measure': 'The efficacy of Generalized Anxiety Disorder 7-items', 'timeFrame': '2 weeks after the first visit', 'description': 'observe the efficacy by the score of Generalized Anxiety Disorder 7-items (GAD-7)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['somatization symptom score', 'SSS checklist', 'coronary angiography', 'Patient Health Questionnaire', 'Generalized Anxiety Disorder 7-items'], 'conditions': ['Syndrome X']}, 'descriptionModule': {'briefSummary': 'A comparative study is conducted on the patients with suspected coronary artery disease (CAD). The patient will undergo coronary angiography after a somatic symptom scale (SSS) survey is carried out combining with Patient Health Questionnaire (PHQ-9) and Generalized Anxiety Disorder 7-items (GAD-7). Patient is then treated according to the checklist score and coronary angiography result. The efficacy, sensitivity and specificity of the SSS checklist will be evaluated during following up.', 'detailedDescription': 'The presentation of physical complaints such as chest discomfort suggestive of suspicious coronary artery disease (CAD) but remain unexplained after negative finding from coronary angiography represents one of the most frustrating and puzzling problems in clinical medicine.A comparative study is conducted on the patients with suspected coronary artery disease. A somatic symptom scale (SSS) survey is carried out combining with Patient Health Questionnaire (PHQ-9) and Generalized Anxiety Disorder 7-items (GAD-7). Patient is treated according to the checklist score and coronary angiography result. Three surveys will be re-conducted 2 weeks after treatment. The sensitivity and specificity of the SSS checklist will be evaluated during following up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with suspected coronary artery disease\n\nExclusion Criteria:\n\n* patients who have lost their self assessments of capacity.\n* patients who have been previously confirmed serious mental disorders.\n* patients who is taking anti-anxiety agents or anti-depression agents.'}, 'identificationModule': {'nctId': 'NCT02723903', 'briefTitle': 'Hierarchical Treatment Based on Somatization Symptom Checklist', 'organization': {'class': 'OTHER', 'fullName': 'RenJi Hospital'}, 'officialTitle': 'Efficacy of Hierarchical Treatment For Suspected Coronary Heart Disease Based on Somatization Symptom Checklist and Coronary Angiography', 'orgStudyIdInfo': {'id': '81470391'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'with CAD and somatic symptom', 'description': 'Patients with the coronary artery disease and with the somatization symptom, the investigators treat the patients according to the guideline for coronary artery disease and anti-somatic agents (Deanxit, Prozac according to the somatization type)', 'interventionNames': ['Drug: Deanxit', 'Drug: Prozac', 'Procedure: coronary artery disease treatment']}, {'type': 'OTHER', 'label': 'without CAD, with somatic symptom', 'description': 'Only somatic symptom is presented, anti-somatic agents is prescribed (Deanxit, Prozac according to the somatization type)', 'interventionNames': ['Drug: Deanxit', 'Drug: Prozac']}, {'type': 'NO_INTERVENTION', 'label': 'without CAD, without somatic symptom', 'description': 'Have neither coronary artery disease nor somatic symptom, continue follow-up.'}, {'type': 'OTHER', 'label': 'with CAD, without somatic symptom', 'description': 'Patient with the coronary artery disease, without the somatization symptom, the investigators treat the patients according to coronary artery disease treatment guideline including coronary artery stent implantation,medication according to the severity of stenosis of the coronary arteries.', 'interventionNames': ['Procedure: coronary artery disease treatment']}], 'interventions': [{'name': 'Deanxit', 'type': 'DRUG', 'otherNames': ['Deanxit as anti-anxiety treatment'], 'description': 'we use Deanxit for the patient with anxiety', 'armGroupLabels': ['with CAD and somatic symptom', 'without CAD, with somatic symptom']}, {'name': 'Prozac', 'type': 'DRUG', 'otherNames': ['Prozac as anti-depression treatment'], 'description': 'we use Prozac for the patient with depression', 'armGroupLabels': ['with CAD and somatic symptom', 'without CAD, with somatic symptom']}, {'name': 'coronary artery disease treatment', 'type': 'PROCEDURE', 'otherNames': ['re-vascularization'], 'description': 'including medication, coronary artery stent implantation according to the severity of stenosis of the coronary arteries', 'armGroupLabels': ['with CAD and somatic symptom', 'with CAD, without somatic symptom']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wang lingling, Postgraduate', 'role': 'CONTACT', 'phone': '15000053961'}, {'name': 'Chen bingxu, Postgraduate', 'role': 'CONTACT', 'phone': '15800539513'}], 'facility': 'Renji Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Mao Jialiang, Docter', 'role': 'CONTACT', 'email': 'maoji@aliyun.com', 'phone': '13311606283', 'phoneExt': '68383477'}, {'name': 'Jiang Meng, Doctor', 'role': 'CONTACT', 'email': 'jiangmeng0919@163.com', 'phone': '13788912766', 'phoneExt': '58752445'}], 'overallOfficials': [{'name': 'Mao Jialiang, Docter', 'role': 'STUDY_CHAIR', 'affiliation': 'Renji hosipital,Jiaotong University, School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RenJi Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}