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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GW117 Tablets 20mg group | Experimental |
| |
| placebo | Placebo Comparator |
| |
| GW117 Tablets 40mg group | Experimental |
| |
| GW117 Tablets 60mg group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GW117 Tablets | Drug | GW117 Tablets 20mg orally once a day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The change in Hamilton Depression Scale-17(HAMD-17) total score from baseline | 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. | 8 week |
| Measure | Description | Time Frame |
|---|---|---|
| The change inMontgomery-Åsberg Depression Rating Scale (MADRS) total score from baseline | 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. | 8 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hebei Mental Health Center | Baoding | China | ||||
| Beijing Huilongguan Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41425080 | Derived | 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. |
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| GW117 Tablets |
| Drug |
GW117 Tablets 20mg*2 orally once a day |
|
| GW117 Tablets | Drug | GW117 Tablets 20mg*3 orally once a day |
|
| Placebo | Drug | placebo orally once a day |
|
| The response rate of HAMD-17 | The response definition of HAMD-17 is that the reduction rate of HAMD-17 score relative to baseline is ≥ 50%. | 8 week |
| The response rate of MADRS | The response definition of MADRS is that the reduction rate of MADRS score relative to baseline is ≥ 50%. | 8 week |
| The changes in Clinical Global Impression Scale-Improvement (CGI-I )total score from baseline | 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. | 8 week |
| The changes in Clinical Globel Impression-Severity(CGI-S) from baseline | 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. This 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. | 8 week |
| Beijing |
| China |
| Capital Medical University Affliated Anding HospitalContact | Beijing | China |
| Peking University Sixth Hospital | Beijing | China |
| Chengdu No.4 People's Hospital | Chengdu | China |
| Chongqing Mental Health Center | Chongqing | China |
| The third hospital of Daqing | Daqing | China |
| Huzhou Third People's Hospital | Huzhou | China |
| Jilin Neuropsychiatric Hospital | Jilin City | China |
| The Third People's Hospital of Mianyang City | Mianyang | China |
| Shanghai Mental Health Center | Shanghai | China |
| Shenzhen Kangning Hospital | Shenzhen | China |
| The First Hospital of Hebei Medical University | Shijiazhuang | China |
| Tianjin Anding Hospital | Tianjin | China |
| Wuxi Mental Health Center | Wuxi | China |
| Xijing Hospital, the Fourth Military Medical University, Xi'an, China | Xi'an | China |
| Zhumadian Second People's Hospital | Zhumadian | China |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000722503 | GW117 |
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