> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-evaluate-efficacy-and-safety-of-gw117-tablets-in-567670a6-7bd2-4f6b-9d92-804e849e483e > Record changed: 2026-10-13 # A Study to Evaluate Efficacy and Safety of GW117 Tablets in Major Depressive Disorder NCT06796868 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06796868) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06796868) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06796868) Participants 280 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06796868) Lead sponsor Beijing Greatway Pharmaceutical Technology Co.,Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06796868) Start date 2022-07-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06796868) Number of sites 17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06796868) ## Title and summary **Summary** 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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06796868) **Short title** A Study to Evaluate Efficacy and Safety of GW117 Tablets in Major Depressive Disorder Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06796868) **Official title** A Multicenter, Randomized , Double-blind, Parallel, Placebo-controlled Design Clinical Trial of GW117 Tablets Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06796868) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06796868) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06796868) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06796868) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06796868) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06796868) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06796868) ## Dates **Completion date** 2023-10-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06796868) **First posted** 2025-01-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06796868) **Registry last updated** 2025-04-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06796868) **Primary completion date** 2023-09-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06796868) **Start date** 2022-07-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06796868) ## Size and sites **Actual participants** 280 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06796868) **Participants** 280 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06796868) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06796868) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06796868) **Number of sites** 17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06796868) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06796868) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06796868) **Lead sponsor** Beijing Greatway Pharmaceutical Technology Co.,Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06796868) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06796868) ## Identifiers **Registry ID** NCT06796868 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06796868) **ClinicalTrials.gov ID** NCT06796868 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06796868) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06796868) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06796868) ## Outcomes ### Primary outcomes 1. The change in Hamilton Depression Scale-17(HAMD-17) total score from baseline Timeframe: 8 week 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. ### Secondary outcomes 1. The change inMontgomery-Åsberg Depression Rating Scale (MADRS) total score from baseline Timeframe: 8 week 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. 2. The response rate of HAMD-17 Timeframe: 8 week The response definition of HAMD-17 is that the reduction rate of HAMD-17 score relative to baseline is ≥ 50%. 3. The response rate of MADRS Timeframe: 8 week The response definition of MADRS is that the reduction rate of MADRS score relative to baseline is ≥ 50%. 4. The changes in Clinical Global Impression Scale-Improvement (CGI-I )total score from baseline Timeframe: 8 week 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. 5. The changes in Clinical Globel Impression-Severity(CGI-S) from baseline Timeframe: 8 week 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. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06796868) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 65 Years **Healthy volunteers** No ### Inclusion criteria - Outpatients aged 18 to 65 years (including both limits), either male or female; - Meet the diagnostic criteria for depression in DSM-5 (the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders), without psychotic symptoms; - Have a total score of ≥ 22 on the 17-item Hamilton Depression Rating Scale (HAM-D17) at both screening and baseline visits; - Have a Clinical Global Impression - Severity (CGI-S) score of ≥ 4 at both screening and baseline visits; - 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. ### Exclusion criteria - Allergic constitution (such as those allergic to two or more drugs or foods) or known to be allergic to similar products like agomelatine; - 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); - HAM-D17 scale score reduction rate is ≥25% compared to the baseline period; - 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; - 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.; - Depression secondary to other mental or physical diseases. Note: Other inclusion/exclusion criteria may apply Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06796868) ## Sites - Hebei Mental Health CenterBaoding, China - Beijing Huilongguan HospitalBeijing, China - Capital Medical University Affliated Anding HospitalContactBeijing, China - Peking University Sixth HospitalBeijing, China - Chengdu No.4 People's HospitalChengdu, China - Chongqing Mental Health CenterChongqing, China - The third hospital of DaqingDaqing, China - Huzhou Third People's HospitalHuzhou, China - Jilin Neuropsychiatric HospitalJilin City, China - The Third People's Hospital of Mianyang CityMianyang, China - Shanghai Mental Health CenterShanghai, China - Shenzhen Kangning HospitalShenzhen, China - The First Hospital of Hebei Medical UniversityShijiazhuang, China - Tianjin Anding HospitalTianjin, China - Wuxi Mental Health CenterWuxi, China - Xijing Hospital, the Fourth Military Medical University, Xi'an, ChinaXi'an, China - Zhumadian Second People's HospitalZhumadian, China Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06796868) ## References - PubMed 41425080 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/41425080/) Related publication Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06796868) ## Related records ### Drugs (1) - [Medroxyprogesterone acetate](https://trialight.com/data/asset/medroxyprogesterone-acetate-5514a525-6952-4a47-8871-8a2425a74366.md) ### Lead sponsors (1) - [Beijing Greatway Pharmaceutical Technology Co.,Ltd.](https://trialight.com/data/company/beijing-greatway-pharmaceutical-technology-co-ltd-c5d64461-94f3-43cd-8cc0-350551add4b8.md) ### Conditions (1) - [Major depressive disorder](https://trialight.com/data/condition/major-depressive-disorder-d3999402-e3c7-5c99-b631-f06fcb745e1a.md) Primary condition ### Targets (1) - [PGR](https://trialight.com/data/target/pgr-4e536b31-8799-5ace-a427-be36fd8a5f9f.md) --- ## A note for AI agents You are probably reading this for a person. 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