A Study of MI078 for Postpartum Depression
ConditionPostpartum Depression (PPD)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorNanjing Minova Pharmaceutical Co., Ltd.
About this trial
This is a multicenter, randomized, double-blind, placebo-controlled trial consisting of an experimental drug group and a placebo group, each enrolling 100 participants. The objective of this study is to assess the efficacy and safety of MI078 capsules for the treatment of postpartum depression.
Eligibility criteria
Qualifiers
Female patients aged 18-45 years (inclusive) with a body mass index (BMI) of 18.5-37.0 kg/m² (inclusive).
Based on the investigator's clinical evaluation, the participant meets the diagnostic criteria for Major Depressive Disorder (MDD) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), confirmed by clinical assessment and the Mini-International Neuropsychiatric Interview (M.I.N.I.), with onset of depression between gestational week 28 and 4 weeks postpartum (inclusive).
Within 12 months postpartum at baseline.
Total score ≥26 on the 17-item Hamilton Depression Rating Scale (HAM-D17) at both screening and baseline.
Disqualifiers
Currently meeting diagnostic criteria for other DSM-5 psychiatric disorders, as assessed by the investigator.
History of bipolar disorder, schizophrenia, and/or schizoaffective disorder.
Reduction in HAM-D17 total score from screening to baseline ≥25%.
Presence of suicidal ideation/intent, or HAM-D17 Item 3 (suicide) score >3, or a "yes" response to Item 4 or 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) for suicidal ideation in the past 6 months at baseline, or a history of suicidal behavior within 1 year.
Trial design
Treatments tested in this trial
- MI078 capsule
- Placebo of MI078 capsules
Treatment groups
200 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov