A Study to Evaluate Efficacy and Safety of GW117 Tablets in Major Depressive Disorder
A Multicenter, Randomized , Double-blind, Parallel, Placebo-controlled Design Clinical Trial of GW117 Tablets
1 other identifier
interventional
280
1 country
17
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2022
Shorter than P25 for phase_2
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 7, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 28, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 12, 2023
CompletedFirst Submitted
Initial submission to the registry
January 22, 2025
CompletedFirst Posted
Study publicly available on registry
January 28, 2025
CompletedApril 23, 2025
January 1, 2025
1.2 years
January 22, 2025
April 22, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (5)
The change inMontgomery-Åsberg Depression Rating Scale (MADRS) total score from baseline
8 week
The response rate of HAMD-17
8 week
The response rate of MADRS
8 week
The changes in Clinical Global Impression Scale-Improvement (CGI-I )total score from baseline
8 week
The changes in Clinical Globel Impression-Severity(CGI-S) from baseline
8 week
Study Arms (4)
GW117 Tablets 20mg group
EXPERIMENTALplacebo
PLACEBO COMPARATORGW117 Tablets 40mg group
EXPERIMENTALGW117 Tablets 60mg group
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Hebei Mental Health Center
Baoding, China
Beijing Huilongguan Hospital
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, 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
Related Publications (1)
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.
PMID: 41425080DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 22, 2025
First Posted
January 28, 2025
Study Start
July 7, 2022
Primary Completion
September 28, 2023
Study Completion
October 12, 2023
Last Updated
April 23, 2025
Record last verified: 2025-01