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Postpartum DepressionPhase 2NCT06963580

Efficacy of MI078 Capsules in Treating Postpartum Depression

A Phase 2 study testing MI078 capsule dose 1 and MI078 capsule dose 2 in people with Postpartum Depression, run by Nanjing Minova Pharmaceutical Co., Ltd. at 21 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is a multicenter, randomized, double-blind, placebo-controlled trial. It includes three groups. Each group will enroll 24 participants. The trial aims todetermine： To evaluate the efficacy of MI078 capsules in treating postpartum depression and to explore the optimal dosing regimen for MI078 capsules. Read more about this study

Who is it for?
Ages 18 to 45 years, women only
Conditions the study is for
Postpartum Depression
What is being tested?
MI078 capsule dose 1 and MI078 capsule dose 2
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
72 participants
Where
21 sitesChina
Study dates
9 Sep 2024to 7 Aug 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

21 sites in 1 country.

21 sites in 1 country

China21 sites

  • Beijing HuiLongGuan Hospital

    Beijing, Beijing Municipality, 100096

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

    Chengdu, Sichuan, 610072

  • Shunde Hospital of Southern Medical University

    Foshan, Guangdong, 528308

  • The First Affiliated Hospital of Jinan University

    Guangzhou, Guangdong, 510630

  • The People's Hospital of Guizhou Province

    Guiyang, Guizhou, 550002

  • The First People's Hospital of Hangzhou

    Hangzhou, Zhejiang, 310006

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310009

  • First Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan, 650032

  • Linfen Central Hospital

    Linfen, Shanxi, 041000

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

  • Guangxi Zhuang Autonomous Region People's Hospital

    Nanning, Guangxi, 530021

  • The Affiliated Kangning Hospital of Ningbo University

    Ningbo, Zhejiang, 315201

  • The First Affiliated Hospital of Ningbo University

    Ningbo, Zhejiang

  • Shanghai Mental Health Center

    Shanghai, Shanghai Municipality, 200122

  • Shanghai Pudong New Area Mental Health Center

    Shanghai, Shanghai Municipality, 200124

  • The First Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050023

  • The First Hospital of Shanxi Medical University

    Taiyuan, Shanxi, 030001

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325000

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

    Wuhu, Anhui, 241000

  • Xiamen Xian Yue Hospital

    Xiamen, Fujian

  • Xingtai People's Hospital

    Xingtai, Hebei, 054001

Other trials in China

About this study

Official title: 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 a multicenter, randomized, double-blind, placebo-controlled trial. It includes three groups. Each group will enroll 24 participants. The trial aims todetermine： To evaluate the efficacy of MI078 capsules in treating postpartum depression and to explore the optimal dosing regimen for MI078 capsules.

To assess the safety of MI078 capsules in postpartum depression patients.

Read the detailed description

This study employs a multicenter, randomized, double-blind, placebo-controlled parallel design. It plans to include three groups: one for the test drug at dose 1, one for the test drug at dose 2, and one for the placebo group, with 24 subjects in each group. The study consists of a screening period (D-14 to D-1), a treatment period (Day 1 to Day 4), and a follow-up period (Day 5 to Day 31). Enrolled subjects will be randomly assigned in a 1:1:1 ratio and will take the study medication for a total of 3 days.

Being tested
MI078 capsule dose 1, MI078 capsule dose 2, placebo
Medical subject headings
Depression, Postpartum

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MI078 capsule dose 1Drug

    MI078 capsule dose 1 for 3 days

  • MI078 capsule dose 2Drug

    MI078 capsule dose 2 for 3 days

  • placeboDrug

    placebo for 3 days

Study groups in NCT06963580
Study groupRoleWhat they receive
MI078 capsule dose 1ExperimentalMI078 capsule dose 1
Receives: Drug: MI078 capsule dose 1
MI078 capsule dose 2ExperimentalMI078 capsule dose 2
Receives: Drug: MI078 capsule dose 2
placeboPlacebo comparatorPlacebo of MI078 capsules
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in HAM-D17 total score

    The Seventeen-Item Hamilton Rating Scale for Depression (HAM-D17) contains 17 individual ratings related to the following symptoms: depressed mood, feelings of guilt, suicide, insomnia (initial, middle, and late), work and interests, psychomotor retardation, psychomotor agitation, anxiety (psychic and somatic), gastrointestinal symptoms, general somatic symptoms, sexual interest, hypochondriasis, insight, and weight loss. The total score ranges from 0 to 52, with higher scores indicating more severe depression.

    Measured: up to day 31

Secondary outcomes (8)

  1. HAM-D17 response

    Defined as having a 50% or greater reduction from baseline in HAM-D17 total score. The total score ranges from 0 to 52, with higher scores indicating more severe depression.

    Measured: up to day 31

  2. HAM-D17 remission

    Defined as having a HAM-D17 total score ≤7. The total score ranges from 0 to 52, with higher scores indicating more severe depression

    Measured: up to day 31

  3. Change from baseline in the CGI-S score

    The CGI-S scale is a 7-point scale that requires the Investigator to assess how mentally ill is the patient at this time. 1 - normal, not at all ill; 2 - borderline mentally ill; 3 - mildly ill; 4 - moderately ill; 5 - markedly ill; 6 - severely ill; or 7 - among the most extremely ill patients

    Measured: up to day 31

  4. Clinical Global Impression - Improvement (CGI-I) scale positive response

    The CGI-I scale is a 7-point scale that requires the Investigator to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of study drug treatment. 1 - very much improved; 2 - much improved; 3 - minimally improved; 4 - no change; 5 - minimally worse; 6 - much worse; or 7 - very much worse

    Measured: up to day 31

  5. Change from baseline in MADRS total score

    The MADRS contains 10 individual items related to the following symptoms: apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. The total score ranges from 0 to 60, with higher scores indicating more severe depression

    Measured: up to day 31

  6. Change from baseline in Edinburgh Postnatal Depression Scale (EPDS) total score

    The Edinburgh Postnatal Depression Scale (EPDS) is a set of 10 screening questions. The total score ranges from 0 to 30, with higher scores indicating more severe depression.

    Measured: up to day 31

  7. Change from baseline in Hamilton Anxiety Rating Scale (HAM-A) total score

    The HAM-A contains 14 individual ratings related to the following symptoms: anxious mood, tension, fears, insomnia, intellectual, depressed mood, somatic (muscular), somatic (sensory), cardiovascular symptoms, respiratory symptoms, gastrointestinal symptoms, genitourinary symptoms, autonomic symptoms, and behavior at interview. The total score ranges from 0 to 56, with higher scores indicating more severe anxiety.

    Measured: up to day 31

  8. Safety Evaluation Indicators

    Adverse events (AEs), Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), clinical laboratory test, 12-lead electrocardiogram (ECG)，C-SSRS，PWC-20

    Measured: up to day 31

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2025
  2. Study start9 Sep 2024
  3. Primary completion7 Aug 2025
  4. Study completion7 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06963580
Sponsor's protocol ID
2024-43
Status last verified
Jun 2026
First submitted
28 Apr 2025
Last updated
25 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MI078 capsule dose 1 and MI078 capsule dose 2 in people with Postpartum Depression, run by Nanjing Minova Pharmaceutical Co., Ltd. at 21 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in HAM-D17 total score (time frame: up to day 31). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06963580.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.

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