A Phase 2 Study to Evaluate Efficacy and Safety of KH607 Tablets in Woman With Postpartum Depression
NCT ID: NCT07096791
Last Updated: 2025-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
72 participants
INTERVENTIONAL
2025-07-31
2027-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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KH607
Participants receive KH607, 30 milligrams (mg), oral tablets, once daily for 14 days, as tolerated.
KH607 tablet
oral，once daily for 14 days
Placebo
Eligible participants receive matching placebo tablets once daily for 14 days.
placebo
oral，once daily for 14 days
Interventions
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KH607 tablet
oral，once daily for 14 days
placebo
oral，once daily for 14 days
Eligibility Criteria
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Inclusion Criteria
2. Participant had a major depressive episode that began no earlier than the third trimester and no later than the first 4 weeks following delivery, as diagnosed by Structured Clinical Interview for Diagnostic and Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) .
3. Participant was \<=12 months postpartum.
4. Participant has a Hamilton Rating Scale for Depression (HAM-D) total score ≥26 at screening and Day 1 (prior to dosing).
5. Participant either must have ceased lactating at screening or, if still lactating or actively breastfeeding at screening, must agree to temporarily cease giving breast milk to her infant(s).
6. Fully understand the procedures and sigh the informed consent.
Exclusion Criteria
2. 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.
3. Participant has active psychosis.
4. 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.
5. Subject has a history of sleep apnea.
6. 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.
7. 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.
18 Years
45 Years
FEMALE
No
Sponsors
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Chengdu Kanghong Pharmaceutical Group Co., Ltd.
INDUSTRY
Responsible Party
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Central Contacts
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Other Identifiers
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KH607-40201
Identifier Type: -
Identifier Source: org_study_id
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