Major Depressive Disorder (MDD)Phase 3NCT07741331
Compare the Efficacy and Safety of KH607 Tablets Versus Vortioxetine Hydrobromide Tablets in Adult Patients With Major Depressive Disorder
A Phase 3 study testing KH607 tablets, Vortioxetine Hydrobromide Tablets and Part B: KH607 in people with Major Depressive Disorder (MDD), run by Chengdu Kanghong Pharmaceutical Group Co., Ltd..
Trial summary
This trial includes a short-term study and a long-term study. The short-term study is a multicenter, randomized, double-Blind, double-Dummy, Parallel-Controlled study with a 6-week duration. 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?
- KH607 tablets, Vortioxetine Hydrobromide Tablets and Part B: KH607
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 326 participants
- Where
- No sites listed yet
- Study dates
- Jul 2026to Dec 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Age: 18 to 65 years old (inclusive), Male or female.
- Based on investigator's clinical assessment, study participants meet the diagnostic criteria for Major Depressive Disorder (MDD) as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), with a diagnosis of single episode or recurrent episodes (ICD-10 codes: 296.2/296.3), without psychotic features. For patients with first-episode depression, the current episode must have a duration of ≥3 months; for patients with recurrent depression, the current depressive episode must have a duration of ≥1 month
- Depressive episode confirmed by the Mini International Neuropsychiatric Interview Version 7.0.0 (M.I.N.I. 7.0.0).
- Patients must have a Montgomery and Åsberg Depression Rating Scale (MADRS) total score ≥26, a Clinical Global Impression-Severity (CGI-S) score ≥4, and a score ≥2 on Item 1 (Depressed Mood) of the HAM-D17 at screening and baseline
- Body weight ≥45.0 kg for females or ≥50.0 kg for males, with a body mass index (BMI) ≥19 kg/m²
- Participants who is taking antidepressants must have stopped for 7 days or 5 half-lives of the antidepressant prior to Day 1.
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- Participant is willing to stop other antidepressants, antipsychotics, mood stabilizers, sedatives and hypnotics during the trial.
- Fully understand the procedures and sigh the informed consent.
- Only for long-term trials:
- Subjects who complete the short-term trial (Visit 8 completion), have a ≥50% reduction from short-term trial baseline in MADRS total score at Visit 8, and volunteer to enter the long-term trial.
Who cannot join
- Other psychiatric disorders meeting DSM-5 criteria, including but not limited to schizophrenia spectrum and other psychotic disorders, bipolar and related disorders, panic disorder, agoraphobia, social anxiety disorder, obsessive-compulsive disorder, post-traumatic stress disorder, generalized anxiety disorder, anorexia nervosa and bulimia nervosa, neurodevelopmental disorders, schizoaffective disorder, or any other psychiatric disorder that, in the Investigator's judgment, may compromise subject compliance.
- A reduction of ≥25% in MADRS total score at baseline compared with the screening visit (this criterion does not apply if baseline and screening assessments are performed at the same visit).
- Participants with clinically significant risk of suicide or self-harm, defined as any of the following:
- A score ≥4 on Item 10 (Suicidal Thoughts) of the MADRS;
- An answer of "Yes" to Question 4 (active suicidal ideation with intent without specific plan) or Question 5 (active suicidal ideation with specific plan and intent) of the C-SSRS within the past 6 months at screening, or a suicide-related behavior within the past 6 months (any "Yes" response for Actual Attempt, Interrupted Attempt, or Aborted Attempt).
- Participants meeting any of the following depressive disorder diagnoses:
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- Poor response to adequate dose and adequate duration (at least 6 weeks) of two or more antidepressants with distinct pharmacological mechanisms during a prior depressive episode (based on Investigator interview, to be adjudicated and documented by the Investigator);
- Depressive disorder secondary to other psychiatric disorders or somatic diseases (e.g., depression induced by hypothyroidism);
- Substance/medication-induced depressive disorder.
- Participants receiving structured psychotherapy (interpersonal therapy, psychodynamic therapy, cognitive behavioral therapy, etc.), music therapy, exercise therapy, acupuncture, or other therapies from screening through baseline, who require continuation of such therapies during the study.
- Receipt of depression-related neuromodulation therapies within 1 month prior to enrollment, including but not limited to modified electroconvulsive therapy (MECT), transcranial magnetic stimulation (TMS), vagus nerve stimulation (VNS), deep brain stimulation (DBS).
- Prior use of atypical antipsychotics or mood stabilizers during the current depressive episode (e.g., olanzapine, risperidone, quetiapine, aripiprazole, brexpiprazole, ziprasidone, cariprazine, valproate, lithium carbonate).
- Use of any strong CYP3A4 inhibitor or inducer within 14 days (or 5 half-lives, whichever is longer) prior to enrollment.
- Abnormal hepatic or renal function prior to enrollment: liver function abnormalities (ALT or AST >2×ULN), renal function abnormalities (Cr >1.5×ULN), or other conditions deemed inappropriate for enrollment by the Investigator.
- Positive test results at screening for active hepatitis B (HBV-DNA ≥1000 copies/mL or 200 IU/mL), hepatitis C antibody, syphilis antibody, or human immunodeficiency virus (HIV) antibody.
- 12-lead electrocardiogram (ECG) showing second-degree or third-degree atrioventricular block, long QT syndrome, or QTcF >450 ms (male) / 460 ms (female) prior to enrollment; or other conditions unsuitable for participation as judged by the Investigator (e.g., clinically significant tachyarrhythmia requiring intervention).
- Severe hypothyroidism (TSH ≥10.0 mIU/L).
- Participants with current obstructive sleep apnea and/or narcolepsy.
- Participants who have known or suspected hypersensitivity to vortioxetine hydrobromide, the investigational product or their excipients, or those with allergic diathesis (defined as allergy to at least two different substances).
- Pregnant or breastfeeding women, or women of childbearing potential with a positive pregnancy test at screening.
- Participants or their partners planning pregnancy, sperm donation, or oocyte donation during the study and within 6 months after the last study drug administration, and unwilling to use adequate and effective contraception throughout this period.
- Participants who cannot avoid driving, operating hazardous machinery, or working at heights from the first dose of study drug until 2 weeks after the last dose.
- History of seizures, or any other medical conditions associated with an increased seizure risk (e.g., stroke, severe head trauma, significant metabolic disturbances).
- History of narrow-angle glaucoma or other conditions resulting in elevated intraocular pressure.
- Any other conditions that, in the Investigator's opinion, render the subject unsuitable for participation in this study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Controlled Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of KH607 Tablets in the Treatment of Major Depressive Disorder With Vortioxetine Hydrobromide Tablets as the Active Control
This trial includes a short-term study and a long-term study. The short-term study is a multicenter, randomized, double-Blind, double-Dummy, Parallel-Controlled study with a 6-week duration. The long-term study is a withdrawal follow-up study; participants meeting relapse criteria may receive one cycle of KH607 Tablets treatment.
Read the detailed description
This trial consists of two parts: a short-term study and a long-term study. The short-term study adopts a multicenter, randomized, double-blind, double-Dummy parallel-group design, including a 14-day screening period, 6-week double-blind treatment period; the experimental group receives KH607 tablets for 3 weeks, followed by KH607 placebo for 3 weeks; the control group receives vortioxetine hydrobromide tablets for 6 weeks. In the long-term study, participants will return to the study site for follow-up every 4 weeks for up to 24 weeks. Those who do not meet relapse criteria will receive no antidepressant treatment, while participants meeting relapse criteria will be treated with KH607 Tablets for one cycle.
- Conditions
- Major Depressive Disorder (MDD)
- Being tested
- KH607 tablets, Vortioxetine Hydrobromide Tablets, Part B: KH607
- 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.
KH607 tabletsDrug
oral 20mg, once daily for 21 days.
Vortioxetine Hydrobromide TabletsDrug
oral 10mg, once daily for 42 days.
Part B: KH607Drug
oral 20mg, once daily for 21 days.
| Study group | Role | What they receive |
|---|---|---|
| Part A: KH607 | Experimental | Participants receive KH607, 20 milligrams (mg), oral tablets, once daily for 21 days. Receives: Drug: KH607 tablets |
| Part A: Vortioxetine Hydrobromide | Active comparator | Participants receive Vortioxetine Hydrobromide 10 milligrams (mg), oral tablets, once daily for 42 days. Receives: Drug: Vortioxetine Hydrobromide Tablets |
| Part B: KH607 | Experimental | while participants meeting relapse criteria will be treated with KH607 Tablets for one cycle. All participants will receive 20 mg (2 tablets) KH607 Tablets QN at bedtime. Treatment will continue for 21 consecutive days. Receives: Drug: Part B: KH607 |
What is being measured
The primary outcome is the main question the study is designed to answer.
short-term study: Change From Baseline in the Montgomery and Åsberg Depression Rating Scale (MADRS) Total Score
The MADRS was a ten-item diagnostic questionnaire which psychiatrists used to measure the severity of depressive episodes in participants with mood disorders. Each item yielded a score of 0 to 6. The MADRS total score was calculated as the sum of the 10 individual item scores, which ranged from 0 to 60. Higher MADRS scores indicated more severe depression.
Measured: Baseline to Day 22
Secondary outcomes (24)
short-term study: Change From Baseline in the MADRS Total Score
The MADRS was a ten-item diagnostic questionnaire which psychiatrists used to measure the severity of depressive episodes in participants with mood disorders. Each item yielded a score of 0 to 6. The MADRS total score was calculated as the sum of the 10 individual item scores, which ranged from 0 to 60. Higher MADRS scores indicated more severe depression.
Measured: Baseline up to Day 42
short-term study: Change From Baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D17) Total Score
The HAM-D total score comprised a sum of 17 individual item scores.The total score could range from 0 to 52. Higher scores indicated a greater degree of depression.
Measured: Baseline up to Day 42
short-term study: Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score
The 14-item HAM-A was used to rate the severity of symptoms of anxiety. Scoring for HAM-A was calculated by assigning scores of 0 (not present) to 4 (very severe), with a total score range of 0 to 56. The HAM-A total score was calculated as the sum of the 14 individual item scores.
Measured: Baseline up to Day 42
short-term study: Change from baseline in Clinical Global Impressions-Severity (CGI-S) score
The CGI-S item employed a 7-point Likert scale to measure the overall severtity in the participant's condition.
Measured: Baseline up to Day 42
short-term study: Change in Clinical Global Impressions-Improvement (CGI-I) score
The CGI-I item employed a 7-point Likert scale to measure the overall improvement in the participant's condition post-treatment. The investigator rated the participant's total improvement whether or not it was due entirely to drug treatment. The CGI-I was only rated at post-treatment assessments.
Measured: Baseline up to Day 42
short-term study: Percentage of Participants With HAM-D Response
HAM-D response was defined as having a 50% or greater reduction from baseline in HAM-D total score.
Measured: Day 4,8,15,22,28,42
short-term study: Percentage of Participants With HAM-D Remission
HAM-D remission was defined as having a HAM-D total score of ≤7.
Measured: Day 4,8,15,22,28,42
short-term study: Percentage of Participants With MADRS Response
MADRS response was defined as having a 50% or greater reduction from baseline in MADRS total score.
Measured: Day 4,8,15,22,28,42
short-term study: Percentage of Participants With MADRS Remission
MADRS remission was defined as having a MADRS total score of ≤10.
Measured: Day 4,8,15,22,28,42
short-term study: Number of Participants with Adverse Events
An AE is any untoward medical occurrence in a clinical study participant administered with a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the intervention.
Measured: Baseline up to Day 42
short-term study: Number of Participants with Suicidality Assessment using Columbia-Suicide Severity Rating Scale (C-SSRS)
The C-SSRS is a low-burden measure of the spectrum of suicidal ideation and behavior that was developed to assess severity and track suicidal events through any treatment. The C-SSRS scale consists of 28 items in 4 sections: suicide behavior, actual attempts, suicidal ideation, and intensity of ideation. Suicidal ideation consists of 5 'yes/no' items: wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods (not plan) without intention to act, active suicidal ideation with some intent to act without specific plan, active suicidal ideation with specific plan and intent.
Measured: Baseline up to Day 42
short-term study: Change from Baseline in Physician Withdrawal Checklist (PWC-20) total score
The PWC-20 is a simple and accurate method used to assess potential withdrawal symptoms following cessation of treatment. The PWC-20 is a reliable and sensitive instrument for the assessment of discontinuation symptoms.
Measured: Baseline up to Day 42
long-term study:Time from long-term study Baseline (Day 42) to the First Relapse in Participants
Time from long-term study Baseline (Day 42) to the first relapse will be reported.
Measured: long-term study Baseline (Day 42) up to 24 weeks
long-term study: Change from baseline in total scores of MADRS
The MADRS was a ten-item diagnostic questionnaire which psychiatrists used to measure the severity of depressive episodes in participants with mood disorders. Each item yielded a score of 0 to 6. The MADRS total score was calculated as the sum of the 10 individual item scores, which ranged from 0 to 60. Higher MADRS scores indicated more severe depression.
Measured: long-term study Baseline (Day 42) up to 24 weeks
long-term study: Change from baseline in total scores of HAM-D17
The HAM-D total score comprised a sum of 17 individual item scores.The total score could range from 0 to 52. Higher scores indicated a greater degree of depression.
Measured: long-term study Baseline (Day 42) up to 24 weeks
long-term study: Change from baseline in total scores of HAM-A
The 14-item HAM-A was used to rate the severity of symptoms of anxiety. Scoring for HAM-A was calculated by assigning scores of 0 (not present) to 4 (very severe), with a total score range of 0 to 56. The HAM-A total score was calculated as the sum of the 14 individual item scores.
Measured: long-term study Baseline (Day 42) up to 24 weeks
long-term study: Change from baseline in the CGI-S score
The CGI-S item employed a 7-point Likert scale to measure the overall severtity in the participant's condition.
Measured: long-term study Baseline (Day 42) up to 24 weeks
long-term study: Change in the CGI-I score
The CGI-I item employed a 7-point Likert scale to measure the overall improvement in the participant's condition post-treatment. The investigator rated the participant's total improvement whether or not it was due entirely to drug treatment. The CGI-I was only rated at post-treatment assessments.
Measured: long-term study Baseline (Day 42) up to 24 weeks
long-term study:Percentage of Participants With HAM-D Response
HAM-D response was defined as having a 50% or greater reduction from baseline in HAM-D total score.
Measured: long-term study Baseline (Day 42) up to 24 weeks
long-term study:Percentage of Participants With HAM-D Remission
HAM-D remission was defined as having a HAM-D total score of ≤7.
Measured: long-term study Baseline (Day 42) up to 24 weeks
long-term study:Percentage of Participants With MADRS Response
MADRS response was defined as having a 50% or greater reduction from baseline in MADRS total score.
Measured: long-term study Baseline (Day 42) up to 24 weeks
long-term study: Percentage of Participants With MADRS Remission
MADRS remission was defined as having a MADRS total score of ≤10.
Measured: long-term study Baseline (Day 42) up to 24 weeks
long-term study: Number of Participants with Adverse Events
An AE is any untoward medical occurrence in a clinical study participant administered with a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the intervention.
Measured: long-term study Baseline (Day 42) up to 24 weeks
long-term study: Number of Participants with Suicidality Assessment using Columbia-Suicide Severity Rating Scale (C-SSRS)
The C-SSRS is a low-burden measure of the spectrum of suicidal ideation and behavior that was developed to assess severity and track suicidal events through any treatment. The C-SSRS scale consists of 28 items in 4 sections: suicide behavior, actual attempts, suicidal ideation, and intensity of ideation. Suicidal ideation consists of 5 'yes/no' items: wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods (not plan) without intention to act, active suicidal ideation with some intent to act without specific plan, active suicidal ideation with specific plan and intent.
Measured: long-term study Baseline (Day 42) up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study startJul 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 326 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chengdu Kanghong Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07741331
- Sponsor's protocol ID
- KH607-60102
- Status last verified
- Jun 2026
- First submitted
- 23 Jul 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Controlled Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of KH607 Tablets in the Treatment of Major Depressive Disorder With Vortioxetine Hydrobromide Tablets as the Active Control
- ClinicalTrials.gov ID
- NCT07741331
- Acronym / sponsor ID
- KH607-60102
- Conditions
- Major Depressive Disorder (MDD)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 326 participants (estimated)
- Lead sponsor
- Chengdu Kanghong Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 3 Aug 2026 (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.
This trial includes a short-term study and a long-term study. The short-term study is a multicenter, randomized, double-Blind, double-Dummy, Parallel-Controlled study with a 6-week duration. The long-term study is a withdrawal follow-up study; participants meeting relapse criteria may receive one cycle of KH607 Tablets treatment.
Detailed description
This trial consists of two parts: a short-term study and a long-term study. The short-term study adopts a multicenter, randomized, double-blind, double-Dummy parallel-group design, including a 14-day screening period, 6-week double-blind treatment period; the experimental group receives KH607 tablets for 3 weeks, followed by KH607 placebo for 3 weeks; the control group receives vortioxetine hydrobromide tablets for 6 weeks. In the long-term study, participants will return to the study site for follow-up every 4 weeks for up to 24 weeks. Those who do not meet relapse criteria will receive no antidepressant treatment, while participants meeting relapse criteria will be treated with KH607 Tablets for one cycle.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part A: KH607 | Experimental | Drug: KH607 tabletsParticipants receive KH607, 20 milligrams (mg), oral tablets, once daily for 21 days. |
| Part A: Vortioxetine Hydrobromide | Active comparator | Drug: Vortioxetine Hydrobromide TabletsParticipants receive Vortioxetine Hydrobromide 10 milligrams (mg), oral tablets, once daily for 42 days. |
| Part B: KH607 | Experimental | Drug: Part B: KH607while participants meeting relapse criteria will be treated with KH607 Tablets for one cycle. All participants will receive 20 mg (2 tablets) KH607 Tablets QN at bedtime. Treatment will continue for 21 consecutive days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age: 18 to 65 years old (inclusive), Male or female.
- Based on investigator's clinical assessment, study participants meet the diagnostic criteria for Major Depressive Disorder (MDD) as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), with a diagnosis of single episode or recurrent episodes (ICD-10 codes: 296.2/296.3), without psychotic features. For patients with first-episode depression, the current episode must have a duration of ≥3 months; for patients with recurrent depression, the current depressive episode must have a duration of ≥1 month
- Depressive episode confirmed by the Mini International Neuropsychiatric Interview Version 7.0.0 (M.I.N.I. 7.0.0).
- Patients must have a Montgomery and Åsberg Depression Rating Scale (MADRS) total score ≥26, a Clinical Global Impression-Severity (CGI-S) score ≥4, and a score ≥2 on Item 1 (Depressed Mood) of the HAM-D17 at screening and baseline
- Body weight ≥45.0 kg for females or ≥50.0 kg for males, with a body mass index (BMI) ≥19 kg/m²
Key exclusion criteria (25 listed)
- Other psychiatric disorders meeting DSM-5 criteria, including but not limited to schizophrenia spectrum and other psychotic disorders, bipolar and related disorders, panic disorder, agoraphobia, social anxiety disorder, obsessive-compulsive disorder, post-traumatic stress disorder, generalized anxiety disorder, anorexia nervosa and bulimia nervosa, neurodevelopmental disorders, schizoaffective disorder, or any other psychiatric disorder that, in the Investigator's judgment, may compromise subject compliance.
- A reduction of ≥25% in MADRS total score at baseline compared with the screening visit (this criterion does not apply if baseline and screening assessments are performed at the same visit).
- Participants with clinically significant risk of suicide or self-harm, defined as any of the following:
- Participants meeting any of the following depressive disorder diagnoses:
- Participants receiving structured psychotherapy (interpersonal therapy, psychodynamic therapy, cognitive behavioral therapy, etc.), music therapy, exercise therapy, acupuncture, or other therapies from screening through baseline, who require continuation of such therapies during the study.
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 |
|---|---|---|
| KH607 tabletsoral 20mg, once daily for 21 days. | Drug | Part A: KH607 |
| Vortioxetine Hydrobromide Tabletsoral 10mg, once daily for 42 days. | Drug | Part A: Vortioxetine Hydrobromide |
| Part B: KH607oral 20mg, once daily for 21 days. | Drug | Part B: KH607 |
Primary outcome
short-term study: Change From Baseline in the Montgomery and Åsberg Depression Rating Scale (MADRS) Total Score
Time frame: Baseline to Day 22
The MADRS was a ten-item diagnostic questionnaire which psychiatrists used to measure the severity of depressive episodes in participants with mood disorders. Each item yielded a score of 0 to 6. The MADRS total score was calculated as the sum of the 10 individual item scores, which ranged from 0 to 60. Higher MADRS scores indicated more severe depression.
24 secondary outcomes
short-term study: Change From Baseline in the MADRS Total Score
Time frame: Baseline up to Day 42
short-term study: Change From Baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D17) Total Score
Time frame: Baseline up to Day 42
short-term study: Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score
Time frame: Baseline up to Day 42
short-term study: Change from baseline in Clinical Global Impressions-Severity (CGI-S) score
Time frame: Baseline up to Day 42
short-term study: Change in Clinical Global Impressions-Improvement (CGI-I) score
Time frame: Baseline up to Day 42
short-term study: Percentage of Participants With HAM-D Response
Time frame: Day 4,8,15,22,28,42
short-term study: Percentage of Participants With HAM-D Remission
Time frame: Day 4,8,15,22,28,42
short-term study: Percentage of Participants With MADRS Response
Time frame: Day 4,8,15,22,28,42
short-term study: Percentage of Participants With MADRS Remission
Time frame: Day 4,8,15,22,28,42
short-term study: Number of Participants with Adverse Events
Time frame: Baseline up to Day 42
short-term study: Number of Participants with Suicidality Assessment using Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Baseline up to Day 42
short-term study: Change from Baseline in Physician Withdrawal Checklist (PWC-20) total score
Time frame: Baseline up to Day 42
long-term study:Time from long-term study Baseline (Day 42) to the First Relapse in Participants
Time frame: long-term study Baseline (Day 42) up to 24 weeks
long-term study: Change from baseline in total scores of MADRS
Time frame: long-term study Baseline (Day 42) up to 24 weeks
long-term study: Change from baseline in total scores of HAM-D17
Time frame: long-term study Baseline (Day 42) up to 24 weeks
long-term study: Change from baseline in total scores of HAM-A
Time frame: long-term study Baseline (Day 42) up to 24 weeks
long-term study: Change from baseline in the CGI-S score
Time frame: long-term study Baseline (Day 42) up to 24 weeks
long-term study: Change in the CGI-I score
Time frame: long-term study Baseline (Day 42) up to 24 weeks
long-term study:Percentage of Participants With HAM-D Response
Time frame: long-term study Baseline (Day 42) up to 24 weeks
long-term study:Percentage of Participants With HAM-D Remission
Time frame: long-term study Baseline (Day 42) up to 24 weeks
long-term study:Percentage of Participants With MADRS Response
Time frame: long-term study Baseline (Day 42) up to 24 weeks
long-term study: Percentage of Participants With MADRS Remission
Time frame: long-term study Baseline (Day 42) up to 24 weeks
long-term study: Number of Participants with Adverse Events
Time frame: long-term study Baseline (Day 42) up to 24 weeks
long-term study: Number of Participants with Suicidality Assessment using Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: long-term study Baseline (Day 42) up to 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Individual participant dataSharing planned: Yes
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing KH607 tablets, Vortioxetine Hydrobromide Tablets and Part B: KH607 in people with Major Depressive Disorder (MDD), run by Chengdu Kanghong Pharmaceutical Group Co., Ltd..
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 10 inclusion and 25 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: opening soon, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gang Wang, Medical Doctor (86-010-58303063, adgangwang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
short-term study: Change From Baseline in the Montgomery and Åsberg Depression Rating Scale (MADRS) Total Score (time frame: Baseline to Day 22). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Aug 2026.