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

NCT06796868
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Phase
Phase 2
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Recruitment status
Completed
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Participants
280
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Lead sponsor
Beijing Greatway Pharmaceutical Technology Co.,Ltd.
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Start date
2022-07-07
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Number of sites
17
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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.
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Short title
A Study to Evaluate Efficacy and Safety of GW117 Tablets in Major Depressive Disorder
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Official title
A Multicenter, Randomized , Double-blind, Parallel, Placebo-controlled Design Clinical Trial of GW117 Tablets
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 2
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Study type
Interventional
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Completion date
2023-10-12
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First posted
2025-01-28
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Registry last updated
2025-04-23
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Primary completion date
2023-09-28
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Start date
2022-07-07
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Actual participants
280
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Participants
280
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Participant count basis
Actual
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Protocol amendments
1
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Number of sites
17
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Beijing Greatway Pharmaceutical Technology Co.,Ltd.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06796868
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ClinicalTrials.gov ID
NCT06796868
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. The change in Hamilton Depression Scale-17(HAMD-17) total score from baseline

    Timeframe: 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.

  1. The change inMontgomery-Åsberg Depression Rating Scale (MADRS) total score from baseline

    Timeframe: 8 week

    There are a total of 10 projects in Montgomery-Asberg Depression Rating Scale（MADRS）, each with a 7-point scoring system ranging from 0 to 6 points,for a total possible score of 60. The higher the score, the more severe the degree of depression.

  2. The response rate of HAMD-17

    Timeframe: 8 week

    The response definition of HAMD-17 is that the reduction rate of HAMD-17 score relative to baseline is ≥ 50%.

  3. The response rate of MADRS

    Timeframe: 8 week

    The response definition of MADRS is that the reduction rate of MADRS score relative to baseline is ≥ 50%.

  4. The changes in Clinical Global Impression Scale-Improvement (CGI-I )total score from baseline

    Timeframe: 8 week

    the following one query is rated on a seven-point scale: "Compared to the patient's condition at admission to the project \[prior to medication initiation\], this patient's condition is: 1=very much improved since the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from baseline (the initiation of treatment); 5=minimally worse; 6= much worse; 7=very much worse since the initiation of treatment. the higher the score, the more severe the condition will be.

  5. The changes in Clinical Globel Impression-Severity(CGI-S) from baseline

    Timeframe: 8 week

    The CGI-Severity (CGI-S) is rated on the following seven-point scale: 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. This rating is based upon observed and reported symptoms, behavior, and function in the past seven days. the score should reflect the average severity level across the seven days.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
65 Years
Healthy volunteers
No

  • 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.

  • 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
Sources for eligibility
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  • Hebei Mental Health CenterBaoding, China
  • Beijing Huilongguan HospitalBeijing, China
  • Capital Medical University Affliated Anding HospitalContactBeijing, China
  • Peking University Sixth HospitalBeijing, China
  • Chengdu No.4 People's HospitalChengdu, China
  • Chongqing Mental Health CenterChongqing, China
  • The third hospital of DaqingDaqing, China
  • Huzhou Third People's HospitalHuzhou, China
  • Jilin Neuropsychiatric HospitalJilin City, China
  • The Third People's Hospital of Mianyang CityMianyang, China
  • Shanghai Mental Health CenterShanghai, China
  • Shenzhen Kangning HospitalShenzhen, China
  • The First Hospital of Hebei Medical UniversityShijiazhuang, China
  • Tianjin Anding HospitalTianjin, China
  • Wuxi Mental Health CenterWuxi, China
  • Xijing Hospital, the Fourth Military Medical University, Xi'an, ChinaXi'an, China
  • Zhumadian Second People's HospitalZhumadian, China
Sources for sites
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Sources for references
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Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)

Targets (1)