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

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.

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder (MDD)
• Intervention / Treatment: Drug: GW117 Tablets; Drug: GW117 Tablets; Drug: GW117 Tablets; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 280
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Baoding, China
    • Hebei Mental Health Center
  • Beijing, China
    • Peking University Sixth Hospital
  • Beijing, China
    • Beijing HuiLongGuan Hospital
  • Beijing, China
    • Capital Medical University Affliated Anding HospitalContact
  • Chengdu, China
    • Chengdu No.4 People's Hospital
  • Chongqing, China
    • Chongqing Mental Health Center
  • Daqing, China
    • The third hospital of Daqing
  • Huzhou, China
    • Huzhou third people's Hospital
  • Jilin, China
    • Jilin Neuropsychiatric Hospital
  • Mianyang, China
    • The Third People's Hospital of Mianyang City
  • Shanghai, China
    • Shanghai Mental Health Center
  • Shenzhen, China
    • Shenzhen Kangning Hospital
  • Shijiazhuang, China
    • The First Hospital of Hebei Medical University
  • Tianjin, China
    • Tianjin Anding Hospital
  • Wuxi, China
    • Wuxi Mental Health Center
  • Xi'an, China
    • Xijing Hospital, the Fourth Military Medical University, Xi'an, China
  • Zhumadian, China
    • Zhumadian Second People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo	Drug: Placebo; placebo orally once a day
Experimental: GW117 Tablets 20mg group	Drug: GW117 Tablets; GW117 Tablets 20mg orally once a day; Drug: GW117 Tablets; GW117 Tablets 20mg*2 orally once a day; Drug: GW117 Tablets; GW117 Tablets 20mg*3 orally once a day
Experimental: GW117 Tablets 40mg group	Drug: GW117 Tablets; GW117 Tablets 20mg orally once a day; Drug: GW117 Tablets; GW117 Tablets 20mg*2 orally once a day; Drug: GW117 Tablets; GW117 Tablets 20mg*3 orally once a day
Experimental: GW117 Tablets 60mg group	Drug: GW117 Tablets; GW117 Tablets 20mg orally once a day; Drug: GW117 Tablets; GW117 Tablets 20mg*2 orally once a day; Drug: GW117 Tablets; GW117 Tablets 20mg*3 orally once a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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
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

Collaborators and Investigators

• Sponsor: Beijing Greatway Pharmaceutical Technology Co.,Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2022
• Primary Completion (Actual): September 28, 2023
• Study Completion (Actual): October 12, 2023

Study Registration Dates

• First Submitted: January 22, 2025
• First Submitted That Met QC Criteria: January 22, 2025
• First Posted (Actual): January 28, 2025

Study Record Updates

• Last Update Posted (Actual): April 23, 2025
• Last Update Submitted That Met QC Criteria: April 22, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: GW117-C201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No