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

Beijing Greatway Pharmaceutical Technology Co.,Ltd.

Status and phase: Completed; Phase 2

Conditions: Major Depressive Disorder (MDD)

Treatments: Drug: GW117 Tablets; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06796868

GW117-C201

Details and patient eligibility

About

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.

Enrollment: 280 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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.;
• Depression secondary to other mental or physical diseases. Note: Other inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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280 participants in 4 patient groups, including a placebo group

GW117 Tablets 20mg group

Experimental group

Treatment:

Drug: GW117 Tablets

Drug: GW117 Tablets

Drug: GW117 Tablets

placebo

Placebo Comparator group

Treatment:

Drug: Placebo

GW117 Tablets 40mg group

Experimental group

Treatment:

Drug: GW117 Tablets

Drug: GW117 Tablets

Drug: GW117 Tablets

GW117 Tablets 60mg group

Experimental group

Treatment:

Drug: GW117 Tablets

Drug: GW117 Tablets

Drug: GW117 Tablets