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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorChengdu Kanghong Pharmaceutical Group Co., Ltd.

About this trial

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

Eligibility criteria

Qualifiers

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).

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • KH607 tablet
  • placebo

Treatment groups

72 Participants
are divided into 2 treatment groups

Locations

This trial has no locations