Major Depressive Disorder (MDD)Phase 2NCT06796868
A Study to Evaluate Efficacy and Safety of GW117 Tablets in Major Depressive Disorder
A Phase 2 study testing GW117 Tablets in people with Major Depressive Disorder (MDD), run by Beijing Greatway Pharmaceutical Technology Co.,Ltd. at 17 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder (MDD)
- What is being tested?
- GW117 Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 280 participants
- Where
- 17 sitesChina
- Study dates
- 7 Jul 2022to 12 Oct 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
17 sites in 1 country.
17 sites in 1 country
China17 sites
Hebei Mental Health Center
Baoding
Beijing Huilongguan Hospital
Beijing
Capital Medical University Affliated Anding HospitalContact
Beijing
Peking University Sixth Hospital
Beijing
Chengdu No.4 People's Hospital
Chengdu
Chongqing Mental Health Center
Chongqing
The third hospital of Daqing
Daqing
Huzhou Third People's Hospital
Huzhou
Jilin Neuropsychiatric Hospital
Jilin City
The Third People's Hospital of Mianyang City
Mianyang
Shanghai Mental Health Center
Shanghai
Shenzhen Kangning Hospital
Shenzhen
The First Hospital of Hebei Medical University
Shijiazhuang
Tianjin Anding Hospital
Tianjin
Wuxi Mental Health Center
Wuxi
Xijing Hospital, the Fourth Military Medical University, Xi'an, China
Xi'an
Zhumadian Second People's Hospital
Zhumadian
About this study
Official title: A Multicenter, Randomized , Double-blind, Parallel, Placebo-controlled Design Clinical Trial of GW117 Tablets
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.
- Conditions
- Major Depressive Disorder (MDD)
- Being tested
- GW117 Tablets, Placebo
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GW117 TabletsDrug
GW117 Tablets 20mg orally once a day
GW117 TabletsDrug
GW117 Tablets 20mg*2 orally once a day
GW117 TabletsDrug
GW117 Tablets 20mg*3 orally once a day
PlaceboDrug
placebo orally once a day
| Study group | Role | What they receive |
|---|---|---|
| GW117 Tablets 20mg group | Experimental | Not described Receives: Drug: GW117 Tablets |
| placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| GW117 Tablets 40mg group | Experimental | Not described Receives: Drug: GW117 Tablets |
| GW117 Tablets 60mg group | Experimental | Not described Receives: Drug: GW117 Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in Hamilton Depression Scale-17(HAMD-17) total score from baseline
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.
Measured: 8 week
Secondary outcomes (5)
The change inMontgomery-Åsberg Depression Rating Scale (MADRS) total score from baseline
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.
Measured: 8 week
The response rate of HAMD-17
The response definition of HAMD-17 is that the reduction rate of HAMD-17 score relative to baseline is ≥ 50%.
Measured: 8 week
The response rate of MADRS
The response definition of MADRS is that the reduction rate of MADRS score relative to baseline is ≥ 50%.
Measured: 8 week
The changes in Clinical Global Impression Scale-Improvement (CGI-I )total score from baseline
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.
Measured: 8 week
The changes in Clinical Globel Impression-Severity(CGI-S) from baseline
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.
Measured: 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start7 Jul 2022
- Primary completion28 Sep 2023
- Study completion12 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive Disorder (MDD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Greatway Pharmaceutical Technology Co.,Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06796868
- Sponsor's protocol ID
- GW117-C201
- Status last verified
- Jan 2025
- First submitted
- 22 Jan 2025
- Last updated
- 23 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Shen Y, Hao X, Shi X, Tao Z, Yu X, Wang X, Di X, Yang H, Zhang Y, Li J, Wang Z, Zhang G, Wang J, Jiang Z, Wang R, Liu J, Dong Z, Gu W, Zhang H. Efficacy and safety of GW117 tablets in major depressive disorder: a randomised, double-blind, placebo-controlled, phase 2 dose-finding study. Gen Psychiatr. 2025 Dec 17;38(6):e102337. doi: 10.1136/gpsych-2025-102337. eCollection 2025.
PubMed 41425080
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized , Double-blind, Parallel, Placebo-controlled Design Clinical Trial of GW117 Tablets
- ClinicalTrials.gov ID
- NCT06796868
- Acronym / sponsor ID
- GW117-C201
- Conditions
- Major Depressive Disorder (MDD)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Beijing Greatway Pharmaceutical Technology Co.,Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Jul 2022 (actual)
- Primary completion
- 28 Sep 2023 (actual)
- Study completion
- 12 Oct 2023 (actual)
- First posted
- 28 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| GW117 Tablets 20mg group | Experimental | Drug: GW117 Tablets |
| placebo | Placebo comparator | Drug: Placebo |
| GW117 Tablets 40mg group | Experimental | Drug: GW117 Tablets |
| GW117 Tablets 60mg group | Experimental | Drug: GW117 Tablets |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GW117 TabletsGW117 Tablets 20mg orally once a day | Drug | GW117 Tablets 20mg group |
| GW117 TabletsGW117 Tablets 20mg*2 orally once a day | Drug | GW117 Tablets 40mg group |
| GW117 TabletsGW117 Tablets 20mg*3 orally once a day | Drug | GW117 Tablets 60mg group |
| Placeboplacebo orally once a day | Drug | placebo |
Primary outcome
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.
5 secondary outcomes
The change inMontgomery-Åsberg Depression Rating Scale (MADRS) total score from baseline
Time frame: 8 week
The response rate of HAMD-17
Time frame: 8 week
The response rate of MADRS
Time frame: 8 week
The changes in Clinical Global Impression Scale-Improvement (CGI-I )total score from baseline
Time frame: 8 week
The changes in Clinical Globel Impression-Severity(CGI-S) from baseline
Time frame: 8 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2025.
- Derived from this study: PubMed 41425080Shen Y, Hao X, Shi X, Tao Z, Yu X, Wang X, Di X, Yang H, Zhang Y, Li J, Wang Z, Zhang G, Wang J, Jiang Z, Wang R, Liu J, Dong Z, Gu W, Zhang H. Efficacy and safety of GW117 tablets in major depressive disorder: a randomised, double-blind, placebo-controlled, phase 2 dose-finding study. Gen Psychiatr. 2025 Dec 17;38(6):e102337. doi: 10.1136/gpsych-2025-102337. eCollection 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GW117 Tablets in people with Major Depressive Disorder (MDD), run by Beijing Greatway Pharmaceutical Technology Co.,Ltd. at 17 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in Hamilton Depression Scale-17(HAMD-17) total score from baseline (time frame: 8 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06796868, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2025.