Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2026-01-02 @ 5:47 PM
Study NCT ID:
NCT03148535
Status:
UNKNOWN
Last Update Posted:
2017-05-11
First Post:
2017-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Guidance Model of Standardized Treatment of Antidepressants in Bipolar Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016651', 'term': 'Lithium Carbonate'}], 'ancestors': [{'id': 'D002254', 'term': 'Carbonates'}, {'id': 'D000468', 'term': 'Alkalies'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D002255', 'term': 'Carbonic Acid'}, {'id': 'D017554', 'term': 'Carbon Compounds, Inorganic'}, {'id': 'D018020', 'term': 'Lithium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2018-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-05-09', 'studyFirstSubmitDate': '2017-05-09', 'studyFirstSubmitQcDate': '2017-05-09', 'lastUpdatePostDateStruct': {'date': '2017-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HRSD reduction ratio', 'timeFrame': '8 weeks', 'description': 'HRSD reduction ratio'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['the Use of Antidepressants in Patients With Bipolar Depression']}, 'descriptionModule': {'briefSummary': 'The bipolar depression patients of 18-55 years old were recruited. At the time of enrollment, the demographic, symptomatic, neuropsychological, neurobiological and genetic data was collected. After the completion of the baseline assessment and examination, the patients were given lithium carbonate or lithium carbonate combined with SSRI antidepressant treatment. Clinical evaluation was performed at 2 and 8 weeks after treatment, including the therapeutic efficacy and adverse drug reactions, and monitoring of serum lithium concentration. The patients further receive the fMRI scans after treatment for 8 weeks. Through above work, this study aimed to provide some guidance for the use of antidepressants in patients with bipolar depression.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 18-55 years old, bipolar depression\n\nExclusion Criteria:\n\n* other mental illness, serious somatic illnesses, MRI contradictions.'}, 'identificationModule': {'nctId': 'NCT03148535', 'briefTitle': 'Guidance Model of Standardized Treatment of Antidepressants in Bipolar Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Peking University'}, 'officialTitle': 'Clinical Psychopharmacology Division Institute of Mental Health, Peking University', 'orgStudyIdInfo': {'id': '2016-1-4111'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'lithium carbonate', 'description': 'recieve lithium carbonate', 'interventionNames': ['Drug: Lithium Carbonate']}, {'type': 'EXPERIMENTAL', 'label': 'lithium carbonate combined with SSRI antidepressant treatment', 'description': 'recieve lithium carbonate combined with SSRI antidepressant treatment', 'interventionNames': ['Drug: lithium carbonate combined with SSRI antidepressant treatment']}], 'interventions': [{'name': 'Lithium Carbonate', 'type': 'DRUG', 'description': 'bipolar depression recieve lithium Carbonate treatment', 'armGroupLabels': ['lithium carbonate']}, {'name': 'lithium carbonate combined with SSRI antidepressant treatment', 'type': 'DRUG', 'description': 'lithium carbonate combined with SSRI antidepressant treatment', 'armGroupLabels': ['lithium carbonate combined with SSRI antidepressant treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100191', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Tianmei Si, PhD.', 'role': 'CONTACT', 'email': 'si.tian-mei@163.com', 'phone': '8610-82801960'}, {'name': 'Tianmei Si, PhD.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Institute of mental health, Peking University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '050000', 'city': 'Shijiazhuang', 'state': 'Hebei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xueyi Wang, Professor', 'role': 'CONTACT', 'phone': '0311-85917290'}, {'name': 'Xueyi Wang', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'The first hospital of Hebei Province University', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}, {'zip': '210000', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhijian Yao, PhD.', 'role': 'CONTACT', 'email': 'zhijianyao@163.com', 'phone': '86-13851580276'}], 'facility': 'Nanjing Brain Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '116000', 'city': 'Dalian', 'state': 'Liaoning', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shoufu Xie, MD.', 'role': 'CONTACT', 'email': 'shoufuxie@126.com', 'phone': '86-18441168381'}], 'facility': "Dalian No.7 People's Hospital", 'geoPoint': {'lat': 38.91222, 'lon': 121.60222}}], 'centralContacts': [{'name': 'Ji-Tao Li, MD', 'role': 'CONTACT', 'email': 'ljt_102124@163.com', 'phone': '010-62723742'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Psychopharmacology Division Institute of Mental Health', 'investigatorFullName': 'Si Tianmei', 'investigatorAffiliation': 'Peking University'}}}}