NCT06796868CompletedPhase 2
A Multicenter, Randomized , Double-blind, Parallel, Placebo-controlled Design Clinical Trial of GW117 Tablets
Beijing Greatway Pharmaceutical Technology Co.,Ltd.17 sites in 1 country280 target enrollmentStarted: July 7, 2022Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 280
- Locations
- 17
- Primary Endpoint
- The change in Hamilton Depression Scale-17(HAMD-17) total score from baseline
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
GW117 Tablets 20mg group
Experimental
Intervention: GW117 Tablets (Drug)
placebo
Placebo Comparator
Intervention: Placebo (Drug)
GW117 Tablets 40mg group
Experimental
Intervention: GW117 Tablets (Drug)
GW117 Tablets 60mg group
Experimental
Intervention: GW117 Tablets (Drug)
Outcomes
Primary Outcomes
The change in Hamilton Depression Scale-17(HAMD-17) total score from baseline
Time Frame: 8 week
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.
Secondary Outcomes
- The response rate of HAMD-17(8 week)
- The response rate of MADRS(8 week)
- The change inMontgomery-Åsberg Depression Rating Scale (MADRS) total score from baseline(8 week)
- The changes in Clinical Global Impression Scale-Improvement (CGI-I )total score from baseline(8 week)
- The changes in Clinical Globel Impression-Severity(CGI-S) from baseline(8 week)
Investigators
Study Sites (17)
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