A Study of MI078 for Postpartum Depression

Official title

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase 3 Clinical Trial of MI078 Capsules for the Treatment of Patients With Postpartum Depression

Overview

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.

Detailed description

This study is designed as a multicenter, randomized, double-blind, placebo-controlled parallel-group trial. It plans to enroll two groups - one receiving the investigational drug and the other receiving placebo - with 100 participants per group. The study includes a screening period (Day -14 to Day -1), a treatment period (Days 1 to 4), and a follow-up period (Days 5 to 31). Eligible participants will be randomized in a 1:1 ratio and will take the study drug for a total of 3 days.

Interventions

• Drug MI078 capsule
  MI078 capsule for 3 days
• Drug Placebo of MI078 capsules
  Placebo for 3days

Primary outcome measures

• Change from baseline in HAM-D17 total score [Time frame: up to day 31]

Secondary outcome measures (7)

• Change from baseline in the CGI-S score [Time frame: up to day 31]
• HAM-D17 response [Time frame: up to day 31]
• HAM-D17 remission [Time frame: up to day 31]
• Clinical Global Impression - Improvement (CGI-I) scale positive response [Time frame: up to day 31]
• Change from baseline in MADRS total score [Time frame: up to day 31]
• Change from baseline in Edinburgh Postnatal Depression Scale (EPDS) total score [Time frame: up to day 31]
• Change from baseline in Hamilton Anxiety Rating Scale (HAM-A) total score [Time frame: up to day 31]

Eligibility criteria

Inclusion criteria

• 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.
• Understand and voluntarily participate in this trial, agree to comply with all study requirements, and provide written informed consent prior to any study-specific procedures.
• Able to communicate well with the investigator, willing and able to comply with lifestyle restrictions or requirements specified in the protocol, and capable of completing the trial as required.

Exclusion criteria

• 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.
• Meeting diagnostic criteria for treatment-resistant depression.
• Continuous use of therapeutic doses of antidepressants for more than 14 days during the current episode.
• Discontinuation of psychotropic medications for less than 5 half-lives prior to the first dose of study drug.
• Need for concomitant use of other psychoactive drugs during the treatment period, including antidepressants, antipsychotics, mood stabilizers, and sedative-hypnotics (excluding non-benzodiazepines).
• Discontinuation of strong CYP3A4 inducers or inhibitors for less than 5 half-lives prior to the first dose of study drug.
• Receipt of systematic psychotherapy (e.g., interpersonal therapy, psychodynamic therapy, cognitive-behavioral therapy) or psychiatric-related acupuncture within 1 week prior to the first dose, or planned receipt of such treatments during the trial.
• Receipt of other physical treatments for psychiatric disorders (e.g., modified electroconvulsive therapy, transcranial magnetic stimulation, psychiatric-related laser therapy, vagus nerve stimulation, deep brain stimulation, light therapy) within 1 month prior to screening.
• Presence of severe or unstable cardiovascular, hepatic, renal, hematological, endocrine (e.g., uncontrolled hyper- or hypothyroidism), neurological (e.g., epilepsy, Parkinson's disease, multiple sclerosis, Huntington's disease, history of seizure disorder \[except single febrile seizure in childhood\]), gastrointestinal (e.g., history of gastrointestinal disease or surgery that may interfere with drug absorption, distribution, metabolism, or excretion), or other systemic or organ diseases, as judged by the investigator.
• History of malignancy within 1 year prior to screening.
• Participation in another drug trial within 3 months prior to screening, or participation in a medical device trial within 1 month prior to screening (defined as having received investigational drug or device treatment).
• Major surgery (excluding cesarean section) within 1 month prior to screening, or planned surgery during the trial period.
• History of hypersensitivity (allergy to at least 2 substances) or known allergy to progesterone.
• Positive pregnancy test at screening or baseline (for participants who are 4 weeks postpartum, a positive result requires retesting), or unwillingness to use effective contraception throughout the trial and for at least 3 months after the last dose of study drug, or plans for oocyte donation during this period.
• Clinically significant abnormal 12-lead electrocardiogram (ECG) or laboratory findings at screening or baseline that, in the investigator's opinion, may affect the trial, including but not limited to alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2× upper limit of normal (ULN), or serum creatinine >1.5× ULN.
• Currently breastfeeding and unwilling to discontinue breastfeeding during the treatment period and for 7 days after the last dose.
• Any physical/psychological illness or condition that, in the investigator's opinion, may increase the risk of the trial, affect compliance with the protocol, or interfere with the completion of the study, or any other condition that the investigator deems unsuitable for participation in this trial.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

China · 36 centers

• The Second Affiliated Hospital of Anhui Medical University — Hefei
• Chongqing Three Gorges Hospital — Chongqing
• The Affiliated Hospital of Chongqing Medical University — Chongqing
• Xiamen Xianyue Hospital — Xiamen
• Gansu Provincial Hospital of Traditional Chinese Medicine — Lanzhou
• The First Affiliated Hospital of Jinan University — Guangzhou
• Zhaoqing Third People's Hospital — Zhaoqing
• Guangxi Zhuang Autonomous Region Brain Hospital — Liuzhou
• … and 28 more centers

Identifiers

NCT: NCT07721961 · No. (118)-2026245FS-2

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗