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Not yet recruitingNCT07741240Updated Aug 3, 2026

A Study of KH607 as Monotherpy in Adults Participants With Major Depressive Disorder

A Phase 3 interventional study of KH607 tablets and placebo in Major Depressive Disorder (MDD), sponsored by Chengdu Kanghong Pharmaceutical Group Co., Ltd.. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-08-03.

Sponsored by Chengdu Kanghong Pharmaceutical Group Co., Ltd. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
232
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Major Depressive Disorder (MDD)
03

In context

Depressive Disorder, Major

2,741 studies on the registry are indexed under Depressive Disorder, Major; 559 are open to participants now.

This study's planned enrollment of 232 is above the median of 80 across 2,283 interventional studies indexed under Depressive Disorder, Major.

Browse Depressive Disorder, Major studies →

Lead sponsor

Chengdu Kanghong Pharmaceutical Group Co., Ltd. is the lead sponsor of 11 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  1. Age: 18 to 65 years old (inclusive), Male or female.
  2. 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
  3. Depressive episode confirmed by the Mini International Neuropsychiatric Interview Version 7.0.0 (M.I.N.I. 7.0.0).
  4. 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
  5. Body weight ≥45.0 kg for females or ≥50.0 kg for males, with a body mass index (BMI) ≥19 kg/m²
  6. Participants who is taking antidepressants must have stopped for 7 days or 5 half-lives of the antidepressant prior to Day 1.
  7. Participant is willing to stop other antidepressants, antipsychotics, mood stabilizers, sedatives and hypnotics during the trial.

  8. Fully understand the procedures and sigh the informed consent.

    Only for long-term studys:

  9. 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.

Key Exclusion Criteria:

  1. 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.
  2. 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).

  3. Participants with clinically significant risk of suicide or self-harm, defined as any of the following:

    1. A score ≥4 on Item 10 (Suicidal Thoughts) of the MADRS;
    2. 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).

  4. Participants meeting any of the following depressive disorder diagnoses:

    1. 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);
    2. Depressive disorder secondary to other psychiatric disorders or somatic diseases (e.g., depression induced by hypothyroidism);
    3. Substance/medication-induced depressive disorder.
  5. 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.
  6. 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).
  7. 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).
  8. Use of any strong CYP3A4 inhibitor or inducer within 14 days (or 5 half-lives, whichever is longer) prior to enrollment.
  9. 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.
  10. 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.
  11. 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).
  12. Severe hypothyroidism (TSH ≥10.0 mIU/L).
  13. Participants with current obstructive sleep apnea and/or narcolepsy.
  14. 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).
  15. Pregnant or breastfeeding women, or women of childbearing potential with a positive pregnancy test at screening.
  16. 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.
  17. 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.
  18. Any other conditions that, in the Investigator's opinion, render the subject unsuitable for participation in this study.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
232 participants (estimated)

Study arms

  • Experimental
    Part A: KH607

    Participants receive KH607, 20 milligrams (mg), oral tablets, once daily for 21 days, as tolerated.

    Drug: KH607 tablets

  • Placebo comparator
    Part A: Placebo

    Eligible participants receive matching placebo tablets once daily for 21 days.

    Drug: placebo

  • Experimental
    Part B: KH607

    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.

    Drug: KH607 tablets

Interventions

  • DrugKH607 tablets

    oral 20mg, once daily for 21 days

  • Drugplacebo

    oral, once daily for 21 days

  • DrugKH607 tablets

    oral 20mg, once daily for 21 days

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline up to Day 22

Secondary outcomes

  1. 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.

    Time frame: Baseline up to Day 42

  2. 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.

    Time frame: Baseline up to Day 42

  3. 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.

    Time frame: Baseline up to Day 42

  4. 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.

    Time frame: Baseline up to Day 42

  5. 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.

    Time frame: Baseline up to Day 42

  6. 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.

    Time frame: Baseline up to Day 42

  7. 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.

    Time frame: Baseline up to Day 42

  8. 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.

    Time frame: Baseline up to Day 42

  9. Double Blind (DB) Treatment Phase: Percentage of Participants With MADRS Remission

    MADRS remission was defined as having a MADRS total score of ≤10.

    Time frame: Baseline up to Day 42

  10. 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.

    Time frame: Baseline up to Day 42

  11. 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.

    Time frame: Baseline up to Day 42

  12. 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.

    Time frame: Baseline up to Day 42

  13. 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.

    Time frame: OL Baseline (Day 42) up to 27 weeks

  14. 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.

    Time frame: OL Baseline (Day 42) up to 27 weeks

  15. 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

    Time frame: OL Baseline (Day 42) up to 27 weeks

  16. 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.

    Time frame: OL Baseline (Day 42) up to 27 weeks

  17. 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.

    Time frame: OL Baseline (Day 42) up to 27 weeks

  18. 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.

    Time frame: OL Baseline (Day 42) up to 27 weeks

  19. Open-Label (OL) Treatment Phase: Change from Baseline in CGI-S

    Open-Label (OL) Treatment Phase: Change from Baseline in CGI-S

    Time frame: OL Baseline (Day 42) up to 27 weeks

  20. 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.

    Time frame: OL Baseline (Day 42) up to 27 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07741240
Lead sponsor
Chengdu Kanghong Pharmaceutical Group Co., Ltd.
Responsible party
Sponsor
First posted
Aug 3, 2026
Start date
Jul 2026 (estimated)
Primary completion
Dec 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Aug 3, 2026

Study contacts

Gang Wang, Medical Doctor
Contact
adgangwang@163.com
86-010-58303063
Bing Bing Fu, Medical Doctor
Contact
fbbkidd@126.com
86-010-58303063

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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