Using MI078 capsules to treat postpartum depression

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of MI078 Capsule in Patients With Postpartum Depression

This study is testing if MI078 capsules can help women with postpartum depression feel better compared to a placebo.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 72 (estimated)
• Ages: 18 Years to 45 Years
• Sex: Female
• Sponsor: Nanjing Minova Pharmaceutical Co., Ltd. (Industry-sponsored)
• Locations: 21 sites (Wuhu, Anhui and 20 other locations)
• Trial ID: NCT06963580 on ClinicalTrials.gov

What this trial studies

This multicenter, randomized, double-blind, placebo-controlled trial aims to evaluate the efficacy of MI078 capsules in treating postpartum depression. The study will include three groups of participants, each receiving either a different dose of MI078 or a placebo. Participants will be enrolled for a total of 31 days, including a screening period, a treatment period of 3 days, and a follow-up period. The trial will assess both the efficacy and safety of MI078 capsules in women diagnosed with major depressive disorder occurring during or after pregnancy.

Who should consider this trial

Good fit: Ideal candidates are females aged 18 to 45 with a BMI between 18.5 and 37.0 who have been diagnosed with major depressive disorder during or after pregnancy.

Not a fit: Patients who do not meet the inclusion criteria, such as those outside the specified age range or without a diagnosis of major depressive disorder, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide an effective option for women suffering from postpartum depression.

How similar studies have performed: Other studies have shown promise in treating postpartum depression with pharmacological interventions, suggesting potential for success with this approach.

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.

Where this trial is running

Wuhu, Anhui and 20 other locations

• The Affiliated Beijing Anding Hospital of Capital Medical University, Wuhu Hospital — Wuhu, Anhui, China (Recruiting)
• Beijing HuiLongGuan Hospital — Beijing, Beijing, China (Recruiting)
• Xiamen Xian Yue Hospital — Xiamen, Fujian, China (Recruiting)
• Shunde Hospital of Southern Medical University — Foshan, Guangdong, China (Recruiting)
• Guangxi Zhuang Autonomous Region People's Hospital — Nanning, Guangxi, China (Recruiting)
• The People's Hospital of Guizhou Province — Guiyang, Guizhou, China (Recruiting)
• The First Hospital of Hebei Medical University — Shijiazhuang, Hebei, China (Recruiting)
• Xingtai People's Hospital — Xingtai, Hebei, China (Recruiting)
• The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (Recruiting)
• Shanghai Mental Health Center — Shanghai, Shanghai, China (Recruiting)
• Shanghai Pudong New Area Mental Health Center — Shanghai, Shanghai, China (Recruiting)
• Linfen Central Hospital — Linfen, Shanxi, China (Recruiting)
• The First Hospital of Shanxi Medical University — Taiyuan, Shanxi, China (Recruiting)
• Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital — Chengdu, Sichuan, China (Recruiting)
• First Affiliated Hospital of Kunming Medical University — Kunming, Yunnan, China (Recruiting)
• The First People's Hospital of Hangzhou — Hangzhou, Zhejiang, China (Recruiting)
• The Second Affiliated Hospital of Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)
• The Affiliated Kangning Hospital of Ningbo University — Ningbo, Zhejiang, China (Recruiting)
• The First Affiliated Hospital of Ningbo University — Ningbo, Zhejiang, China (Recruiting)
• The First Affiliated Hospital of Wenzhou Medical University — Wenzhou, Zhejiang, China (Recruiting)
• The First Affiliated Hospital of Jinan University — Guangzhou, 广东, China (Recruiting)

Study contacts

• Study coordinator: cuixia zhang

Conditions Postpartum Depression