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Completed

NCT Number: NCT06796868

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

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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Key information

Conditions

Major Depressive Disorder (MDD) Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hebei Mental Health Center, Baoding, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GW117 Tablets

Drug

GW117 Tablets 20mg orally once a day

Placebo

Drug

placebo orally once a day

Primary outcomes

  1. 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

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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Beijing Greatway Pharmaceutical Technology Co.,Ltd.

Industry

Registry information

Official study title

A Multicenter, Randomized , Double-blind, Parallel, Placebo-controlled Design Clinical Trial of GW117 Tablets

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 28, 2025
Registry last updated
Apr 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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