Compare the Efficacy and Safety of KH607 Tablets Versus Vortioxetine Hydrobromide Tablets in Adul… (NCT07741331) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Compare the Efficacy and Safety of KH607 Tablets Versus Vortioxetine Hydrobromide Tablets in Adult Patients With Major Depressive Disorder
326 participantsStarted 2026-07
Plain-language 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. The long-term study is a withdrawal follow-up study; participants meeting relapse criteria may receive one cycle of KH607 Tablets treatment.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. 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.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial compares a new drug called KH607 against vortioxetine, which is already approved for depression — can you explain what is currently known about how KH607 works and whether it might offer any advantages over vortioxetine, which you could potentially prescribe for me right now?
2Since this is a Phase 3 trial, it's further along than early-stage studies, but the drug isn't approved yet — what does that mean for how much is known about KH607's safety profile, and are there any risks I should weigh carefully?
3The trial is listed as 'not yet recruiting,' so it hasn't started enrolling patients — how long might it realistically be before it opens, and does it make sense for me to consider starting a proven treatment in the meantime rather than waiting?
4The main outcome being measured is improvement on the MADRS depression rating scale over a short-term period — what does that mean practically, and how would we know if a treatment is actually working for my specific symptoms during or after the trial?
5Since vortioxetine is already available as a standard treatment for MDD, would you consider it as an option for me now, and how does that compare to the potential benefit of participating in a trial where I might receive either the experimental drug or the existing medication?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
short-term study: Change From Baseline in the Montgomery and Åsberg Depression Rating Scale (MADRS) Total Score
Timeframe: Baseline to Day 22
Trial details
NCT IDNCT07741331
SponsorChengdu Kanghong Pharmaceutical Group Co., Ltd.
. 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:
. 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);