A Phase 2 Study to Evaluate Efficacy and Safety of KH607 Tablets in Woman With Postpartum Depression

NCT07096791 | Not Yet Recruiting Phase 2

• 1 other identifier: KH607-40201
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a study evaluating the efficacy, and safety of KH607 in 72 participants diagnosed with Postpartum Depressive Disorder.

Conditions

Postpartum Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D17) Total Score at Day 15

  The HAM-D 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.

  Baseline, Day15

Secondary Outcomes (8)

• Change From Baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D17) Total Score at all other time points

  Day3,8,21 and 28

• Change From Baseline in the Montgomery and Åsberg Depression Rating Scale (MADRS) Total Score at Day 15 and All Other Time Points

  Day 3,8,15,21 and 28

• Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score at All Time Points

  Day 3,8,15,21 and 28

• Change From Baseline in Self-Reported Measures of Depressive Symptoms, as Assessed by the Edinburgh Postnatal Depression Scale (EPDS) Total Score

  Day 3,8,15,21 and 28

• Percentage of Participants With Clinical Global Impression - Severity (CGI-S) Response

  Day 3,8,15,21 and 28

Study Arms (2)

KH607

EXPERIMENTAL

Participants receive KH607, 30 milligrams (mg), oral tablets, once daily for 14 days, as tolerated.

Drug: KH607 tablet

Placebo

PLACEBO COMPARATOR

Eligible participants receive matching placebo tablets once daily for 14 days.

Drug: placebo

Interventions

KH607 tablet DRUG

oral，once daily for 14 days

KH607

placebo DRUG

oral，once daily for 14 days

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age: 18 to 45 years old (inclusive), female.
• 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) .
• Participant was \<=12 months postpartum.
• Participant has a Hamilton Rating Scale for Depression (HAM-D) total score ≥26 at screening and Day 1 (prior to dosing).
• 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).
• Fully understand the procedures and sigh the informed consent.

You may not qualify if:

• 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.
• Participant has active psychosis.
• 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.

Sponsors & Collaborators

• Chengdu Kanghong Pharmaceutical Group Co., Ltd.: lead

Central Study Contacts

Gang Wang, Medical Doctor

CONTACT

86-010-58303063; adgangwang@163.com

Xue Wang, Medical Doctor

CONTACT

86-010-58303063; xuew37@aliyun.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2025
• First Posted: July 31, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share