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A Study to Evaluate Efficacy and Safety of GW117 Tablets in Major Depressive Disorder | Clinical Trials | Clareo Health

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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

NCT06796868•Beijing Greatway Pharmaceutical Technology Co.,Ltd.

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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.;

Locations (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

Key Dates

Start Date

July 7, 2022

Primary Completion Date

September 28, 2023

Completion Date

October 12, 2023

Last Updated

April 23, 2025

Enrollment

280

ACTUAL participants

Conditions

Major Depressive Disorder (MDD)

Interventions

GW117 Tablets

DRUG

GW117 Tablets

DRUG

GW117 Tablets

DRUG

Placebo

DRUG

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 23, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Evaluate Efficacy and Safety of GW117 Tablets in Major Depressive Disorder

Inclusion Criteria

Exclusion Criteria

A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder

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