Major Depressive Disorder (MDD)Phase 3NCT07741240
A Study of KH607 as Monotherpy in Adults Participants With Major Depressive Disorder
A Phase 3 study testing KH607 tablets 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, placebo-controlled parallel-group study with a 6-week duration. The long-term study is a multicenter, open-label, single-arm study with a maximum duration of 27 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?
- KH607 tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 232 participants
- Where
- No sites listed yet
- Study dates
- Jul 2026to Dec 2027
- 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 17-item Hamilton Depression Rating Scale (HAM-D17) total score ≥24, 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 studys:
- Participants who complete the short-term study (Visit 8 completion), have a ≥50% reduction from short-term study baseline in HAM-D17 total score at Visit 8, and volunteer to enter the long-term study.
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 HAM-D17 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.
- Known or suspected history of hypersensitivity to the investigational product or its excipients, or participants with multiple allergies (defined as allergies to at least 2 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.
- 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: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Parallel-Group Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of KH607 Tablets in the Treatment of Major Depressive Disorder
This trial includes a short-term study and a long-term study. The short-term study is a multicenter, randomized, double-blind, placebo-controlled parallel-group study with a 6-week duration. The long-term study is a multicenter, open-label, single-arm study with a maximum duration of 27 weeks.
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, placebo-controlled parallel-group design, including a 14-day screening period；a 3-week double-blind treatment period, and a 3-week off-drug follow-up period. The long-term study uses a multicenter, open-label, single-arm design. Subjects who complete all study procedures of the short-term study and achieve a ≥50% reduction in the 17-item Hamilton Depression Rating Scale (HAM-D17) score at the end of the short-term study will be eligible to enter the long-term study. All enrolled subjects will receive repeated treatment with KH607 Tablets. The dosing regimen is 20 mg KH607 Tablets administered orally once every night before bedtime. A treatment course consists of 21 consecutive days of dosing, with an interval of no less than 6 weeks between two courses. Subjects may receive a maximum of 3 treatment cycles, and the maximum duration of the long-term study is 27 weeks.
- Conditions
- Major Depressive Disorder (MDD)
- Being tested
- KH607 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.
KH607 tabletsDrug
oral 20mg, once daily for 21 days
placeboDrug
oral, once daily for 21 days
KH607 tabletsDrug
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, as tolerated. Receives: Drug: KH607 tablets |
| Part A: Placebo | Placebo comparator | Eligible participants receive matching placebo tablets once daily for 21 days. Receives: Drug: placebo |
| Part B: KH607 | Experimental | All participants will receive 20 mg (2 tablets) KH607 Tablets QN before go to bed. Treatment will continue for 21 consecutive days, followed by a 6-week drug off-drug observation period. After completing Cycle 1, participants may enter Cycle 2 and Cycle 3 sequentially, up to a maximum of 3 treatment cycles. The maximum duration of the long-term study is 27 weeks. Receives: Drug: KH607 tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Double Blind (DB) Treatment Phase: Change from Baseline in 17-item Hamilton Rating Scale for Depression (HAM-D17) Total Score in Participants with Major Depressive Disorder
The HAM-D is a clinician-administered scale designed to measure depression severity and detects changes due to antidepressant treatment.HAM-D17 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 22
Secondary outcomes (20)
Double Blind (DB) Treatment Phase: Change from Baseline in HAM-D17 Total Score in Participants with Major Depressive Disorder
The HAM-D is a clinician-administered scale designed to measure depression severity and detects changes due to antidepressant treatment.HAM-D17 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
Double Blind (DB) Treatment Phase: 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 up to Day 42
Double Blind (DB) Treatment Phase: 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
Double Blind (DB) Treatment Phase: 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
Double Blind (DB) Treatment Phase: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 CGI-I was only rated at post-treatment assessments.
Measured: Baseline up to Day 42
Double Blind (DB) Treatment Phase: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: Baseline up to Day 42
Double Blind (DB) Treatment Phase: Percentage of Participants With HAM-D Remission
HAM-D remission was defined as having a HAM-D total score of ≤7.
Measured: Baseline up to Day 42
Double Blind (DB) Treatment Phase: Percentage of Participants With MADRS Response
MADRS response was defined as having a 50% or greater reduction from baseline in MADRS total score.
Measured: Baseline up to Day 42
Double Blind (DB) Treatment Phase: Percentage of Participants With MADRS Remission
MADRS remission was defined as having a MADRS total score of ≤10.
Measured: Baseline up to Day 42
Double Blind (DB) Treatment Phase: 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
Double Blind (DB) Treatment Phase: 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
Double Blind (DB) Treatment Phase: 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
Open-Label (OL) Treatment Phase: 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: OL Baseline (Day 42) up to 27 weeks
Open-Label (OL) Treatment Phase: Time from OL Baseline (Day 42) to the First Relapse in Participants
Time from OL Baseline (Day 42) to the first relapse will be reported.
Measured: OL Baseline (Day 42) up to 27 weeks
Open-Label (OL) Treatment Phase: Proportion of participants receiving different numbers of treatment cycles within 27 weeks
Proportion of participants receiving different numbers of treatment cycles
Measured: OL Baseline (Day 42) up to 27 weeks
Open-Label (OL) Treatment Phase: Change from Baseline in HAM-D17 total score
The HAM-D is a clinician-administered scale designed to measure depression severity and detects changes due to antidepressant treatment.HAM-D17 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: OL Baseline (Day 42) up to 27 weeks
Open-Label (OL) Treatment Phase: Change from Baseline in 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: OL Baseline (Day 42) up to 27 weeks
Open-Label (OL) Treatment Phase: Change from Baseline in 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: OL Baseline (Day 42) up to 27 weeks
Open-Label (OL) Treatment Phase: Change from Baseline in CGI-S
Open-Label (OL) Treatment Phase: Change from Baseline in CGI-S
Measured: OL Baseline (Day 42) up to 27 weeks
Open-Label (OL) Treatment Phase: Change in 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 CGI-I was only rated at post-treatment assessments.
Measured: OL Baseline (Day 42) up to 27 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 2027 (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
- 232 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
- NCT07741240
- Sponsor's protocol ID
- KH607-60101
- 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
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Parallel-Group Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of KH607 Tablets in the Treatment of Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT07741240
- Acronym / sponsor ID
- KH607-60101
- Conditions
- Major Depressive Disorder (MDD)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 232 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 2027 (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, placebo-controlled parallel-group study with a 6-week duration. The long-term study is a multicenter, open-label, single-arm study with a maximum duration of 27 weeks.
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, placebo-controlled parallel-group design, including a 14-day screening period；a 3-week double-blind treatment period, and a 3-week off-drug follow-up period. The long-term study uses a multicenter, open-label, single-arm design. Subjects who complete all study procedures of the short-term study and achieve a ≥50% reduction in the 17-item Hamilton Depression Rating Scale (HAM-D17) score at the end of the short-term study will be eligible to enter the long-term study. All enrolled subjects will receive repeated treatment with KH607 Tablets. The dosing regimen is 20 mg KH607 Tablets administered orally once every night before bedtime. A treatment course consists of 21 consecutive days of dosing, with an interval of no less than 6 weeks between two courses. Subjects may receive a maximum of 3 treatment cycles, and the maximum duration of the long-term study is 27 weeks.
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, as tolerated. |
| Part A: Placebo | Placebo comparator | Drug: placeboEligible participants receive matching placebo tablets once daily for 21 days. |
| Part B: KH607 | Experimental | Drug: KH607 tabletsAll participants will receive 20 mg (2 tablets) KH607 Tablets QN before go to bed. Treatment will continue for 21 consecutive days, followed by a 6-week drug off-drug observation period. After completing Cycle 1, participants may enter Cycle 2 and Cycle 3 sequentially, up to a maximum of 3 treatment cycles. The maximum duration of the long-term study is 27 weeks. |
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 17-item Hamilton Depression Rating Scale (HAM-D17) total score ≥24, 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 (23 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 HAM-D17 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 |
| placebooral, once daily for 21 days | Drug | Part A: Placebo |
| KH607 tabletsoral 20mg, once daily for 21 days | Drug | Part B: KH607 |
Primary outcome
Double Blind (DB) Treatment Phase: Change from Baseline in 17-item Hamilton Rating Scale for Depression (HAM-D17) Total Score in Participants with Major Depressive Disorder
Time frame: Baseline up to Day 22
The HAM-D is a clinician-administered scale designed to measure depression severity and detects changes due to antidepressant treatment.HAM-D17 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.
20 secondary outcomes
Double Blind (DB) Treatment Phase: Change from Baseline in HAM-D17 Total Score in Participants with Major Depressive Disorder
Time frame: Baseline up to Day 42
Double Blind (DB) Treatment Phase: Change from Baseline in the Montgomery and Åsberg Depression Rating Scale (MADRS) Total Score
Time frame: Baseline up to Day 42
Double Blind (DB) Treatment Phase: Change from Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score
Time frame: Baseline up to Day 42
Double Blind (DB) Treatment Phase: Change from Baseline in Clinical Global Impressions-Severity (CGI-S) score
Time frame: Baseline up to Day 42
Double Blind (DB) Treatment Phase:Change in Clinical Global Impressions-Improvement (CGI-I) score
Time frame: Baseline up to Day 42
Double Blind (DB) Treatment Phase:Percentage of Participants With HAM-D Response
Time frame: Baseline up to Day 42
Double Blind (DB) Treatment Phase: Percentage of Participants With HAM-D Remission
Time frame: Baseline up to Day 42
Double Blind (DB) Treatment Phase: Percentage of Participants With MADRS Response
Time frame: Baseline up to Day 42
Double Blind (DB) Treatment Phase: Percentage of Participants With MADRS Remission
Time frame: Baseline up to Day 42
Double Blind (DB) Treatment Phase: Number of Participants with Adverse Events
Time frame: Baseline up to Day 42
Double Blind (DB) Treatment Phase: Number of Participants with Suicidality Assessment using Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Baseline up to Day 42
Double Blind (DB) Treatment Phase: Change from Baseline in Physician Withdrawal Checklist (PWC-20) total score
Time frame: Baseline up to Day 42
Open-Label (OL) Treatment Phase: Number of Participants with Adverse Events
Time frame: OL Baseline (Day 42) up to 27 weeks
Open-Label (OL) Treatment Phase: Time from OL Baseline (Day 42) to the First Relapse in Participants
Time frame: OL Baseline (Day 42) up to 27 weeks
Open-Label (OL) Treatment Phase: Proportion of participants receiving different numbers of treatment cycles within 27 weeks
Time frame: OL Baseline (Day 42) up to 27 weeks
Open-Label (OL) Treatment Phase: Change from Baseline in HAM-D17 total score
Time frame: OL Baseline (Day 42) up to 27 weeks
Open-Label (OL) Treatment Phase: Change from Baseline in MADRS total score
Time frame: OL Baseline (Day 42) up to 27 weeks
Open-Label (OL) Treatment Phase: Change from Baseline in HAM-A total score
Time frame: OL Baseline (Day 42) up to 27 weeks
Open-Label (OL) Treatment Phase: Change from Baseline in CGI-S
Time frame: OL Baseline (Day 42) up to 27 weeks
Open-Label (OL) Treatment Phase: Change in CGI-I score
Time frame: OL Baseline (Day 42) up to 27 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 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 23 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. 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 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?
Double Blind (DB) Treatment Phase: Change from Baseline in 17-item Hamilton Rating Scale for Depression (HAM-D17) Total Score in Participants with Major Depressive Disorder (time frame: Baseline up 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.