Efficacy of MI078 Capsules in Treating Postpartum Depression

Launched by NANJING MINOVA PHARMACEUTICAL CO., LTD. · May 6, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a medication called MI078 capsules to see if it can help women who are experiencing postpartum depression, which is a type of depression that can occur after giving birth. The trial is taking place at multiple locations and involves three groups of participants, with 24 women in each group. The main goals are to find out how effective MI078 is for treating postpartum depression and to determine the best dosage. The researchers will also assess how safe the capsules are for the participants.

To be eligible for this trial, women must be between 18 and 45 years old and have a certain level of depression as measured by a specific scoring system. They should have experienced symptoms of depression between the 28th week of pregnancy and four weeks after giving birth, and they need to be within nine months postpartum at the time of screening. Participants will need to agree to follow the study guidelines and provide informed consent. It’s important to note that women with certain mental health conditions, a history of severe suicidal thoughts, or those currently taking other specific medications may not be eligible. Participants can expect regular check-ins and support throughout the study as they take the MI078 capsules.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Female patients aged 18 to 45 years (inclusive) with a Body Mass Index (BMI) ranging from 18.5 to 37.0 kg/m² (inclusive).
• • The patient meets the diagnostic criteria for Major Depressive Disorder (MDD) as defined in the Diagnostic and Statistical Manual of Mental Disorders(DSM-5), based on the investigator's clinical evaluation. The onset of illness must occur between 28 weeks of pregnancy and 4 weeks postpartum (inclusive).
• • The patient is within 9 months postpartum during the screening period.
• • The total score on the HAMD17 is ≥26 during both the screening and baseline periods.
• • The patient understands and voluntarily agrees to participate in the study, consents to comply with all study requirements, and is able to provide written informed consent prior to the initiation of any study-specific procedures.
• • The patient is able to communicate effectively with the investigator, is willing and able to adhere to the lifestyle restrictions or requirements specified in the study protocol, and can cooperate fully in completing the trial.
• Exclusion Criteria:
• • Current diagnosis of another mental disorder according to DSM-5 criteria, as assessed by the investigator
• • History of bipolar disorder, schizophrenia, and/or schizoaffective disorder
• • History of sleep apnea
• • Presence of suicidal ideation/intent, or a score \>3 on Item 3 (suicide) of the HAMD17, or a response of "yes" to Item 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) within the past 6 months, or a history of suicidal behavior within the past year
• • Meeting the diagnostic criteria for treatment-resistant depression
• • Continuous use of therapeutic doses of antidepressants for more than 14 days during the current episode
• • Failure to discontinue psychotropic medications for at least 5 half-lives prior to the use of the study drug.
• • Need for concurrent use of other psychotropic medications, such as antidepressants, antipsychotics, mood stabilizers, and sedative-hypnotics (excluding benzodiazepines), during the trial dosing period.