A Phase 2 Study to Evaluate Efficacy and Safety of KH607 Tablets in Adult Participents With Major… (NCT07101120) | Clinical Trial Compass
CompletedPhase 2
A Phase 2 Study to Evaluate Efficacy and Safety of KH607 Tablets in Adult Participents With Major Depressive Disorder
China126 participantsStarted 2025-03-19
Plain-language summary
This is a two-part (open-label followed by double-blind) study evaluating the safety, tolerability, pharmacokinetics, and efficacy of KH607 in 120 participants diagnosed with moderate or severe Major Depressive Disorder.
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.
. Participant with diagnosis of MDD as diagnosed by Structured Clinical Interview for Diagnostic and Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) , with symptoms that have been present for at least a 4-week period
. Participant has a Hamilton Rating Scale for Depression (HAM-D) total score ≥24 at screening and Day 1 (prior to dosing).
. 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 antidepressant or antianxiety medications and any new pharmacotherapy regimens, including as-needed benzodiazepine anxiolytics and sleep aids, until after completion of the Day 42 visit.
. Fully understand the procedures and sigh the informed consent.
Exclusion criteria
. Participant is currently at significant risk of suicide, or has attempted suicide associated with the current episode of MDD.
. Participant has a history of treatment-resistant depression, defined as persistent depressive symptoms despite treatment with adequate doses of antidepressants from two different classes for an adequate amount of time.
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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
Change From Baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D17) Total Score at Day 15 - Part A
Timeframe: Baseline to Day 15
2
Change From Baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D17) Total Score at Day 22 - Part B
Timeframe: Baseline to Day 22
Trial details
NCT IDNCT07101120
SponsorChengdu Kanghong Pharmaceutical Group Co., Ltd.
. Participant had used modified electroconvulsive therapy (MECT), transcranial magnetic stimulation (TMS), vagus nerve stimulation (VNS), deep brain stimulation (DBS), light therapy, etc. within 1 month prior to Day 1.
. Subject has a history of sleep apnea.
. Participant has a medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder (such as olanzapine, risperidone, quetiapine, aripiprazole, eptifamol, ziprasidone, caliparazine, sodium valproate, lithium carbonate, etc.) within the current major depressive episode.
. Participant has a clinically significant abnormal 12-lead ECG at the screening or baseline visits. NOTE: mean QT interval calculated using the Fridericia method (QTcF) of \>450 msec in males or \>470 msec in females will be the basis for exclusion from the study.