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Can a Three-Day pill ease postpartum depression?

NCT ID NCT07721961

Disease control Sponsor: Nanjing Minova Pharmaceutical Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 23, 2026 · Last updated Jul 24, 2026 · Updated 1 time

Summary

This phase 3 trial tests whether an experimental drug called MI078 can safely reduce symptoms of postpartum depression in new mothers. About 200 women aged 18 to 45 with a recent diagnosis of major depression linked to childbirth will receive either MI078 capsules or a placebo for three days. Researchers will measure changes in depression scores using standard rating scales to see if the drug offers meaningful relief.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
an experimental drug called MI078
What this could lead to
If it works, this could offer a new, fast-acting treatment option for postpartum depression, a condition that affects many new mothers.
What could go wrong
This is an early-phase trial with only 200 participants, so results may not apply to everyone. The drug's safety and effectiveness are still unproven, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 45 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

postpartum depression

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Postpartum depression (PPD)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    36 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Affiliated Hospital of Zunyi Medical University

    RECRUITING

    Zunyi, Guizhou, China

  • Beijing Anding Hospital, Capital Medical University

    RECRUITING

    Beijing, China

  • Beijing Huilongguan Hospital

    RECRUITING

    Beijing, China

  • Chongqing Three Gorges Hospital

    RECRUITING

    Chongqing, Chongqing Municipality, China

  • Gansu Provincial Hospital of Traditional Chinese Medicine

    RECRUITING

    Lanzhou, Gansu, China

  • Ganzhou Third People's Hospital

    RECRUITING

    Ganzhou, Jiangxi, China

  • Guangxi Zhuang Autonomous Region Brain Hospital

    RECRUITING

    Liuzhou, Guangxi, China

  • Guizhou Provincial People's Hospital

    RECRUITING

    Guiyang, Guizhou, China

  • Hainan Anning Hospital

    RECRUITING

    Haikou, Hainan, China

  • Hunan Brain Hospital

    RECRUITING

    Changsha, Hunan, China

  • Huzhou Third People's Hospital

    RECRUITING

    Huzhou, Zhejiang, China

  • Kangning Hospital Affiliated to Ningbo University

    RECRUITING

    Ningbo, Zhejiang, China

  • Linfen Central Hospital

    RECRUITING

    Linfen, Shanxi, China

  • Renmin Hospital of Wuhan University

    RECRUITING

    Wuhan, Hubei, China

  • Shandong Daizhuang Hospital

    RECRUITING

    Jining, Shandong, China

  • Shiyan Taihe Hospital

    RECRUITING

    Shiyan, Hebei, China

  • Sichuan Provincial People's Hospital

    RECRUITING

    Chengdu, Sichuan, China

  • The Affiliated Hospital of Chongqing Medical University

    RECRUITING

    Chongqing, Chongqing Municipality, China

  • The Affiliated Hospital of Southwest Medical University

    RECRUITING

    Luzhou, Sichuan, China

  • The First Affiliated Hospital of Jinan University

    RECRUITING

    Guangzhou, Guangdong, China

  • The First Affiliated Hospital of Nanchang University

    RECRUITING

    Nanchang, Jiangxi, China

  • The First Affiliated Hospital of Ningbo University

    RECRUITING

    Ningbo, Zhejiang, China

  • The First Affiliated Hospital of Zhengzhou University

    RECRUITING

    Zhengzhou, Henan, China

  • The First Hospital of Hebei Medical University

    RECRUITING

    Shijiazhuang, Hebei, China

  • The Second Affiliated Hospital of Anhui Medical University

    RECRUITING

    Hefei, Anhui, China

  • The Second Affiliated Hospital of Xinxiang Medical University (Henan Mental Health)

    RECRUITING

    Xinxiang, Henan, China

  • The Second Hospital of Hebei Medical University

    RECRUITING

    Shijiazhuang, Hebei, China

  • Wuxi Mental Health Center

    RECRUITING

    Wuxi, Jiangsu, China

  • Xi'an Mental Health Center

    RECRUITING

    Xi’an, Shanxi, China

  • Xiamen Xianyue Hospital

    RECRUITING

    Xiamen, Fujian, China

  • Xingtai People's Hospital

    RECRUITING

    Xingtai, Hebei, China

  • Xuzhou Dongfang Hospital

    RECRUITING

    Xuzhou, Jiangsu, China

  • Zhaoqing Third People's Hospital

    RECRUITING

    Zhaoqing, Guangdong, China

  • Zhengzhou Ninth People's Hospital

    RECRUITING

    Zhengzhou, Henan, China

  • Zhumadian Psychiatric Hospital

    RECRUITING

    Zhumadian, Henan, China

  • Zhuzhou Third Hospital (Zhuzhou Psychiatric Hospital)

    RECRUITING

    Zhuzhou, Hunan, China

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