A Study to Evaluate Efficacy and Safety of GW117 Tablets in Major Depressive Disorder
NCT ID: NCT06796868
Last Updated: 2025-04-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
280 participants
INTERVENTIONAL
2022-07-07
2023-10-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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GW117 Tablets 20mg group
GW117 Tablets
GW117 Tablets 20mg orally once a day
placebo
Placebo
placebo orally once a day
GW117 Tablets 40mg group
GW117 Tablets
GW117 Tablets 20mg\*2 orally once a day
GW117 Tablets 60mg group
GW117 Tablets
GW117 Tablets 20mg\*3 orally once a day
Interventions
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GW117 Tablets
GW117 Tablets 20mg orally once a day
GW117 Tablets
GW117 Tablets 20mg\*2 orally once a day
GW117 Tablets
GW117 Tablets 20mg\*3 orally once a day
Placebo
placebo orally once a day
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.;
18 Years
65 Years
ALL
No
Sponsors
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Beijing Greatway Pharmaceutical Technology Co.,Ltd.
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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GW117-C201
Identifier Type: -
Identifier Source: org_study_id
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