Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2025-12-30 @ 4:26 PM
Study NCT ID:
NCT06796868
Status:
COMPLETED
Last Update Posted:
2025-04-23
First Post:
2025-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate Efficacy and Safety of GW117 Tablets in Major Depressive Disorder
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': 'C000722503', 'term': 'GW117'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 280}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2023-10-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-22', 'studyFirstSubmitDate': '2025-01-22', 'studyFirstSubmitQcDate': '2025-01-22', 'lastUpdatePostDateStruct': {'date': '2025-04-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change in Hamilton Depression Scale-17(HAMD-17) total score from baseline', 'timeFrame': '8 week', 'description': 'There are a total of 17 projects in Hamilton Depression Scale-17（HAMD-17）. Scores are distributed on a scale of 0 to 53. Higher scores represent a more severe condition.'}], 'secondaryOutcomes': [{'measure': 'The change inMontgomery-Åsberg Depression Rating Scale (MADRS) total score from baseline', 'timeFrame': '8 week', 'description': 'There are a total of 10 projects in Montgomery-Asberg Depression Rating Scale（MADRS）, each with a 7-point scoring system ranging from 0 to 6 points,for a total possible score of 60. The higher the score, the more severe the degree of depression.'}, {'measure': 'The response rate of HAMD-17', 'timeFrame': '8 week', 'description': 'The response definition of HAMD-17 is that the reduction rate of HAMD-17 score relative to baseline is ≥ 50%.'}, {'measure': 'The response rate of MADRS', 'timeFrame': '8 week', 'description': 'The response definition of MADRS is that the reduction rate of MADRS score relative to baseline is ≥ 50%.'}, {'measure': 'The changes in Clinical Global Impression Scale-Improvement (CGI-I )total score from baseline', 'timeFrame': '8 week', 'description': 'the following one query is rated on a seven-point scale: "Compared to the patient\'s condition at admission to the project \\[prior to medication initiation\\], this patient\'s condition is: 1=very much improved since the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from baseline (the initiation of treatment); 5=minimally worse; 6= much worse; 7=very much worse since the initiation of treatment. the higher the score, the more severe the condition will be.'}, {'measure': 'The changes in Clinical Globel Impression-Severity(CGI-S) from baseline', 'timeFrame': '8 week', 'description': 'The CGI-Severity (CGI-S) is rated on the following seven-point scale: 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients.\n\nThis rating is based upon observed and reported symptoms, behavior, and function in the past seven days. the score should reflect the average severity level across the seven days.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Major Depressive Disorder (MDD)']}, 'referencesModule': {'references': [{'pmid': '41425080', 'type': 'DERIVED', 'citation': 'Shen Y, Hao X, Shi X, Tao Z, Yu X, Wang X, Di X, Yang H, Zhang Y, Li J, Wang Z, Zhang G, Wang J, Jiang Z, Wang R, Liu J, Dong Z, Gu W, Zhang H. Efficacy and safety of GW117 tablets in major depressive disorder: a randomised, double-blind, placebo-controlled, phase 2 dose-finding study. Gen Psychiatr. 2025 Dec 17;38(6):e102337. doi: 10.1136/gpsych-2025-102337. eCollection 2025.'}]}, 'descriptionModule': {'briefSummary': 'The study aims to evaluate the efficacy and safety of GW117 Tablets compared to placebo in adults participants with MDD over a period of 8 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Outpatients aged 18 to 65 years (including both limits), either male or female;\n* Meet the diagnostic criteria for depression in DSM-5 (the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders), without psychotic symptoms;\n* Have a total score of ≥ 22 on the 17-item Hamilton Depression Rating Scale (HAM-D17) at both screening and baseline visits;\n* Have a Clinical Global Impression - Severity (CGI-S) score of ≥ 4 at both screening and baseline visits;\n* Voluntarily participate in this trial and sign the informed consent form, and be able to comply with the planned visits, treatment plan, laboratory tests and other research procedures.\n\nExclusion Criteria:\n\n* Allergic constitution (such as those allergic to two or more drugs or foods) or known to be allergic to similar products like agomelatine;\n* Have previously received adequate and full-course treatment with agomelatine but showed no effect, or treatment-resistant depression (those who have used at least two antidepressants in adequate and full-course treatment but still showed no effect);\n* HAM-D17 scale score reduction rate is ≥25% compared to the baseline period;\n* High suicide risk; history of suicide attempts within one year before screening; suicidal or self-harming behavior during the screening period; score of ≥3 on item 3 (suicide item) of the HAM-D17 scale;\n* Diagnosed with any disease other than depression according to DSM-5, including anxiety disorders, neurodevelopmental disorders, schizophrenia spectrum and other psychotic disorders, bipolar and related disorders, obsessive-compulsive and related disorders, trauma and stress-related disorders, dissociative disorders, anorexia or bulimia nervosa, personality disorders, etc.;\n* Depression secondary to other mental or physical diseases. Note: Other inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT06796868', 'briefTitle': 'A Study to Evaluate Efficacy and Safety of GW117 Tablets in Major Depressive Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Beijing Greatway Pharmaceutical Technology Co.,Ltd.'}, 'officialTitle': 'A Multicenter, Randomized , Double-blind, Parallel, Placebo-controlled Design Clinical Trial of GW117 Tablets', 'orgStudyIdInfo': {'id': 'GW117-C201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GW117 Tablets 20mg group', 'interventionNames': ['Drug: GW117 Tablets']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'GW117 Tablets 40mg group', 'interventionNames': ['Drug: GW117 Tablets']}, {'type': 'EXPERIMENTAL', 'label': 'GW117 Tablets 60mg group', 'interventionNames': ['Drug: GW117 Tablets']}], 'interventions': [{'name': 'GW117 Tablets', 'type': 'DRUG', 'description': 'GW117 Tablets 20mg orally once a day', 'armGroupLabels': ['GW117 Tablets 20mg group']}, {'name': 'GW117 Tablets', 'type': 'DRUG', 'description': 'GW117 Tablets 20mg\\*2 orally once a day', 'armGroupLabels': ['GW117 Tablets 40mg group']}, {'name': 'GW117 Tablets', 'type': 'DRUG', 'description': 'GW117 Tablets 20mg\\*3 orally once a day', 'armGroupLabels': ['GW117 Tablets 60mg group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'placebo orally once a day', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Baoding', 'country': 'China', 'facility': 'Hebei Mental Health Center', 'geoPoint': {'lat': 38.87288, 'lon': 115.46246}}, {'city': 'Beijing', 'country': 'China', 'facility': 'Beijing Huilongguan Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'country': 'China', 'facility': 'Capital Medical University Affliated Anding HospitalContact', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'country': 'China', 'facility': 'Peking University Sixth Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Chengdu', 'country': 'China', 'facility': "Chengdu No.4 People's Hospital", 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'city': 'Chongqing', 'country': 'China', 'facility': 'Chongqing Mental Health Center', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'city': 'Daqing', 'country': 'China', 'facility': 'The third hospital of Daqing', 'geoPoint': {'lat': 46.58333, 'lon': 125.0}}, {'city': 'Huzhou', 'country': 'China', 'facility': "Huzhou Third People's Hospital", 'geoPoint': {'lat': 30.8703, 'lon': 120.0933}}, {'city': 'Jilin', 'country': 'China', 'facility': 'Jilin Neuropsychiatric Hospital', 'geoPoint': {'lat': 43.84652, 'lon': 126.5608}}, {'city': 'Mianyang', 'country': 'China', 'facility': "The Third People's Hospital of Mianyang City", 'geoPoint': {'lat': 31.46784, 'lon': 104.68168}}, {'city': 'Shanghai', 'country': 'China', 'facility': 'Shanghai Mental Health Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shenzhen', 'country': 'China', 'facility': 'Shenzhen Kangning Hospital', 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}, {'city': 'Shijiazhuang', 'country': 'China', 'facility': 'The First Hospital of Hebei Medical University', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}, {'city': 'Tianjin', 'country': 'China', 'facility': 'Tianjin Anding Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'city': 'Wuxi', 'country': 'China', 'facility': 'Wuxi Mental Health Center', 'geoPoint': {'lat': 31.56887, 'lon': 120.28857}}, {'city': "Xi'an", 'country': 'China', 'facility': "Xijing Hospital, the Fourth Military Medical University, Xi'an, China", 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}, {'city': 'Zhumadian', 'country': 'China', 'facility': "Zhumadian Second People's Hospital", 'geoPoint': {'lat': 32.97944, 'lon': 114.02944}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Greatway Pharmaceutical Technology Co.,Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}