Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2026-01-24 @ 10:34 PM
Study NCT ID:
NCT02012504
Status:
UNKNOWN
Last Update Posted:
2013-12-16
First Post:
2013-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antidepressant Monotherapy on Depressive and Anxiety Symptom in Chinese Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-12-10', 'studyFirstSubmitDate': '2013-11-15', 'studyFirstSubmitQcDate': '2013-12-10', 'lastUpdatePostDateStruct': {'date': '2013-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate the score of HAMD17 (Hamilton Depression Rating Scale) and HAMA (Hamilton Anxiety Rating Scale) of patients in each time between two groups', 'timeFrame': 'one year', 'description': 'The efficacy variables is include:\n\nOnset rate: proportion of patient with at least 20% reduction in HAMD total score after 1 week Response rate: proportion of patient with at least 50% reduction in HAMD total score Remission rate: remission is defined as HAMD ≤ 7; remission rate is proportion of patients with remission HAMD total score change from baseline to week 6 and to week 24 (LOCF) during the study.\n\nHAMA and the Mos36-item Short Form Health Survey (SF-36) score Change from baseline to week6 and to week 24 (LOCF) during the study.'}], 'secondaryOutcomes': [{'measure': 'Evaluate the symptom of depression, anxiety and quality of life in each time between two groups', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Adverse Drug Reaction', 'Anxiety Disorders and Symptoms']}, 'descriptionModule': {'briefSummary': 'The primary objective is to evaluate the improvement of antidepressant monotherapy on depressive and anxiety symptom in Chinese patients who meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for the comorbidity of major depressive disorder (MDD) and generalized anxiety disorder (GAD)', 'detailedDescription': 'To evaluate the improvement of the quality of life of antidepressant monotherapy on Chinese patients who meet DSM-5 criteria for the comorbidity of MDD and GAD. To monitor adverse events (AEs) and serious adverse events (SAEs) of antidepressant monotherapy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Chinese patients who meet DSM-5 criteria for the combidity of MDD and GAD', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. First episode outpatients in department of psychiatry, aged 18-65 years\n2. Comorbidity of MDD and GAD according to DSM-5 criteria Hamilton Depression score (HAMD) of ≥18 at screening\n3. HAMA≥14 at screening\n4. Medically stable\n5. Provision of written, informed consent.\n\nExclusion Criteria:\n\n1. Suicide ideation\n2. Use antidepressants within at least 14 days before study begin\n3. Substance or alcohol dependence at enrolment (except dependence in full remission, and except for caffeine or nicotine dependence)\n4. Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse within 4 weeks prior to enrolment\n5. Unstable or inadequately treated medical illness (e.g. congestive heart failure, angina pectoris, hypertension, renal or hepatic dysfunction, cerebrovascular disease ) as judged by the investigator\n6. Women in pregnancy or lactation\n7. Medical conditions that would affect absorption, distribution, metabolism or excretion of study treatment.\n8. Medical history with seizure disorder, except for febrile convulsion\n9. Participation in another clinical study within 4 weeks (or longer time according to the local requirement)\n10. Receive Electroconvulsive therapy (ECT) before study begin'}, 'identificationModule': {'nctId': 'NCT02012504', 'briefTitle': 'Antidepressant Monotherapy on Depressive and Anxiety Symptom in Chinese Patients', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Zhongshan Hospital'}, 'officialTitle': 'Antidepressant Monotherapy on Depressive and Anxiety Symptom in Chinese Patients Who Meet Comorbidity of Major Depressive Disorder (MDD) and Generalized Anxiety Disorder (GAD)', 'orgStudyIdInfo': {'id': 'B2012-127'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Western medicine', 'description': 'venlafaxine or escitalopram'}, {'label': 'Chinese medcine', 'description': 'Shuganjieyu capsule'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiao Huang', 'role': 'CONTACT', 'phone': '+862164041990'}], 'facility': 'Zhongshan Hospital, Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Xiao Huang', 'role': 'CONTACT', 'phone': '+862164041990', 'phoneExt': '3012'}], 'overallOfficials': [{'name': 'Xiao Huang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fudan University'}, {'name': 'Jian l Ji, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fudan University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Zhongshan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}