Clinical trial NCT06796868: A Study to Evaluate Efficacy and Safety of GW117 Tablets in Major Depressive Disorder
Official title: A Multicenter, Randomized , Double-blind, Parallel, Placebo-controlled Design Clinical Trial of GW117 Tablets
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Major Depressive Disorder (MDD)
Lead sponsor: Beijing Greatway Pharmaceutical Technology Co.,Ltd.
Sponsor class: INDUSTRY
First posted: 2025-01-28
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: The change in Hamilton Depression Scale-17(HAMD-17) total score from baseline
timeFrame: 8 week
Secondary outcomes:
measure: The change inMontgomery-Åsberg Depression Rating Scale (MADRS) total score from baseline
timeFrame: 8 week
measure: The response rate of HAMD-17
timeFrame: 8 week
measure: The response rate of MADRS
timeFrame: 8 week
measure: The changes in Clinical Global Impression Scale-Improvement (CGI-I )total score from baseline
timeFrame: 8 week
measure: The changes in Clinical Globel Impression-Severity(CGI-S) from baseline
timeFrame: 8 week
Other outcomes:
Locations:
city: Baoding
country: China
facility: Hebei Mental Health Center
city: Beijing
country: China
facility: Beijing Huilongguan Hospital
city: Beijing
country: China
facility: Capital Medical University Affliated Anding HospitalContact
city: Beijing
country: China
facility: Peking University Sixth Hospital
city: Chengdu
country: China
facility: Chengdu No.4 People's Hospital
city: Chongqing
country: China
facility: Chongqing Mental Health Center
city: Daqing
country: China
facility: The third hospital of Daqing
city: Huzhou
country: China
facility: Huzhou Third People's Hospital
city: Jilin
country: China
facility: Jilin Neuropsychiatric Hospital
city: Mianyang
country: China
facility: The Third People's Hospital of Mianyang City
city: Shanghai
country: China
facility: Shanghai Mental Health Center
city: Shenzhen
country: China
facility: Shenzhen Kangning Hospital
city: Shijiazhuang
country: China
facility: The First Hospital of Hebei Medical University
city: Tianjin
country: China
facility: Tianjin Anding Hospital
city: Wuxi
country: China
facility: Wuxi Mental Health Center
city: Xi'an
country: China
facility: Xijing Hospital, the Fourth Military Medical University, Xi'an, China
city: Zhumadian
country: China
facility: Zhumadian Second People's Hospital
Study officials:
References: