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New pill hopes to lift postpartum depression in days

NCT ID NCT06963580

Symptom relief 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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a new capsule called MI078 in 72 women with postpartum depression. The women took the drug or a placebo for 3 days. Researchers measured depression scores to see if the drug helps symptoms and to find the best dose. The trial is complete, and results will show if MI078 is safe and effective.

What this could mean

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

Active substance
MI078 capsule
What this could lead to
If it works, this could point toward a new short-term treatment for postpartum depression.
What could go wrong
This is an early Phase 2 trial with only 72 people, so results may not apply to everyone. The drug may not work better than placebo or could have side effects.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

72 people

The number who actually took part.

Started

Sep 2024

Finished

Aug 2025

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 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.

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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

Contacts and locations

Locations

  • Beijing HuiLongGuan Hospital

    Beijing, Beijing Municipality, 100096, China

  • First Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan, 650032, China

  • Guangxi Zhuang Autonomous Region People's Hospital

    Nanning, Guangxi, 530021, China

  • Linfen Central Hospital

    Linfen, Shanxi, 041000, China

  • Shanghai Mental Health Center

    Shanghai, Shanghai Municipality, 200122, China

  • Shanghai Pudong New Area Mental Health Center

    Shanghai, Shanghai Municipality, 200124, China

  • Shunde Hospital of Southern Medical University

    Foshan, Guangdong, 528308, China

  • Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital

    Chengdu, Sichuan, 610072, China

  • The Affiliated Beijing Anding Hospital of Capital Medical University, Wuhu Hospital

    Wuhu, Anhui, 241000, China

  • The Affiliated Kangning Hospital of Ningbo University

    Ningbo, Zhejiang, 315201, China

  • The First Affiliated Hospital of Jinan University

    Guangzhou, Guangdong, 510630, China

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006, China

  • The First Affiliated Hospital of Ningbo University

    Ningbo, Zhejiang, China

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325000, China

  • The First Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050023, China

  • The First Hospital of Shanxi Medical University

    Taiyuan, Shanxi, 030001, China

  • The First People's Hospital of Hangzhou

    Hangzhou, Zhejiang, 310006, China

  • The People's Hospital of Guizhou Province

    Guiyang, Guizhou, 550002, China

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310009, China

  • Xiamen Xian Yue Hospital

    Xiamen, Fujian, China

  • Xingtai People's Hospital

    Xingtai, Hebei, 054001, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.