Postpartum Depression (PPD)Phase 3NCT07721961
A Study of MI078 for Postpartum Depression
A Phase 3 study testing MI078 capsule in people with Postpartum Depression (PPD), run by Nanjing Minova Pharmaceutical Co., Ltd. at 36 sites in China.
Trial summary
This is a multicenter, randomized, double-blind, placebo-controlled trial consisting of an experimental drug group and a placebo group, each enrolling 100 participants. The objective of this study is to assess the efficacy and safety of MI078 capsules for the treatment of postpartum depression. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Postpartum Depression (PPD)
- What is being tested?
- MI078 capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 36 sitesChina
- Study dates
- 10 Jul 2026to Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 18-45 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
36 sites in 1 country. Contact the study team or a site near you to ask about taking part.
36 sites in 1 country
China36 sites, 36 recruiting
- Recruiting
Beijing Anding Hospital, Capital Medical University
Beijing
gang Wang
- Recruiting
Beijing Huilongguan Hospital
Beijing
Fude Yang
- Recruiting
Hunan Brain Hospital
Changsha, Hunan
Ning Yuan
Zhengyu Tang
- Recruiting
Sichuan Provincial People's Hospital
Chengdu, Sichuan
Bo Zhou
- Recruiting
Chongqing Three Gorges Hospital
Chongqing, Chongqing Municipality
Shiyou Tang
- Recruiting
The Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality
Lian Du
- Recruiting
Ganzhou Third People's Hospital
Ganzhou, Jiangxi
Ying Shen
- Recruiting
The First Affiliated Hospital of Jinan University
Guangzhou, Guangdong
- Recruiting
Guizhou Provincial People's Hospital
Guiyang, Guizhou
Hui Xiang
- Recruiting
Hainan Anning Hospital
Haikou, Hainan
Yin Lin
- Recruiting
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui
Feng Geng
- Recruiting
Huzhou Third People's Hospital
Huzhou, Zhejiang
Zhongxia Shen
- Recruiting
Shandong Daizhuang Hospital
Jining, Shandong
Zengxun Liu
- Recruiting
Gansu Provincial Hospital of Traditional Chinese Medicine
Lanzhou, Gansu
Shenghui Huang
- Recruiting
Linfen Central Hospital
Linfen, Shanxi
Dong Yan
- Recruiting
Guangxi Zhuang Autonomous Region Brain Hospital
Liuzhou, Guangxi
Fang Fang
- Recruiting
The Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan
Kezhi Liu
- Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
Ailan Wan
- Recruiting
Kangning Hospital Affiliated to Ningbo University
Ningbo, Zhejiang
- Recruiting
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang
Yunxin Ji
- Recruiting
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei
Cuixia An
- Recruiting
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei
Xiaona Sheng
- Recruiting
Shiyan Taihe Hospital
Shiyan, Hebei
Chunqi Ai
- Recruiting
Renmin Hospital of Wuhan University
Wuhan, Hubei
Qirong Wan
- Recruiting
Wuxi Mental Health Center
Wuxi, Jiangsu
Zhiqiang Wang
- Recruiting
Xi'an Mental Health Center
Xi’an, Shanxi
Huali Lin
- Recruiting
Xiamen Xianyue Hospital
Xiamen, Fujian
Yan Qiu
- Recruiting
Xingtai People's Hospital
Xingtai, Hebei
- Recruiting
The Second Affiliated Hospital of Xinxiang Medical University (Henan Mental Health)
Xinxiang, Henan
Ruiling Zhang
- Recruiting
Xuzhou Dongfang Hospital
Xuzhou, Jiangsu
Shiping Xie
- Recruiting
Zhaoqing Third People's Hospital
Zhaoqing, Guangdong
Guoqiang Cheng
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
Yihui Hao
- Recruiting
Zhengzhou Ninth People's Hospital
Zhengzhou, Henan
Xiaojuan Ma
- Recruiting
Zhumadian Psychiatric Hospital
Zhumadian, Henan
Jingli Wang
- Recruiting
Zhuzhou Third Hospital (Zhuzhou Psychiatric Hospital)
Zhuzhou, Hunan
Xiaoli Liu
- Recruiting
Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou
Guifang Chen
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase 3 Clinical Trial of MI078 Capsules for the Treatment of Patients With Postpartum Depression
This is a multicenter, randomized, double-blind, placebo-controlled trial consisting of an experimental drug group and a placebo group, each enrolling 100 participants. The objective of this study is to assess the efficacy and safety of MI078 capsules for the treatment of postpartum depression.
Read the detailed description
This study is designed as a multicenter, randomized, double-blind, placebo-controlled parallel-group trial. It plans to enroll two groups - one receiving the investigational drug and the other receiving placebo - with 100 participants per group. The study includes a screening period (Day -14 to Day -1), a treatment period (Days 1 to 4), and a follow-up period (Days 5 to 31). Eligible participants will be randomized in a 1:1 ratio and will take the study drug for a total of 3 days.
- Conditions
- Postpartum Depression (PPD)
- Being tested
- MI078 capsule, Placebo of MI078 capsules
- 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 capsuleDrug
MI078 capsule for 3 days
Placebo of MI078 capsulesDrug
Placebo for 3days
| Study group | Role | What they receive |
|---|---|---|
| MI078 capsule | Experimental | MI078 capsules Receives: Drug: MI078 capsule |
| placebo | Placebo comparator | Placebo of MI078 capsules Receives: Drug: Placebo of MI078 capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (7)
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
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
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
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
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
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
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start10 Jul 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum Depression (PPD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Minova Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- gang Wang, Principal investigator, Beijing Anding Hospital, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07721961
- Sponsor's protocol ID
- No. (118)-2026245FS-2
- Status last verified
- Jul 2026
- First submitted
- 10 Jul 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase 3 Clinical Trial of MI078 Capsules for the Treatment of Patients With Postpartum Depression
- ClinicalTrials.gov ID
- NCT07721961
- Acronym / sponsor ID
- No. (118)-2026245FS-2
- Conditions
- Postpartum Depression (PPD)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Nanjing Minova Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Jul 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 23 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, randomized, double-blind, placebo-controlled trial consisting of an experimental drug group and a placebo group, each enrolling 100 participants. The objective of this study is to assess the efficacy and safety of MI078 capsules for the treatment of postpartum depression.
Detailed description
This study is designed as a multicenter, randomized, double-blind, placebo-controlled parallel-group trial. It plans to enroll two groups - one receiving the investigational drug and the other receiving placebo - with 100 participants per group. The study includes a screening period (Day -14 to Day -1), a treatment period (Days 1 to 4), and a follow-up period (Days 5 to 31). Eligible participants will be randomized in a 1:1 ratio and will take the study drug for a total of 3 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MI078 capsule | Experimental | Drug: MI078 capsuleMI078 capsules |
| placebo | Placebo comparator | Drug: Placebo of MI078 capsulesPlacebo of MI078 capsules |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MI078 capsuleMI078 capsule for 3 days | Drug | MI078 capsule |
| Placebo of MI078 capsulesPlacebo for 3days | Drug | placebo |
Primary outcome
Change from baseline in HAM-D17 total score
Time frame: up to day 31
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.
7 secondary outcomes
Change from baseline in the CGI-S score
Time frame: up to day 31
HAM-D17 response
Time frame: up to day 31
HAM-D17 remission
Time frame: up to day 31
Clinical Global Impression - Improvement (CGI-I) scale positive response
Time frame: up to day 31
Change from baseline in MADRS total score
Time frame: up to day 31
Change from baseline in Edinburgh Postnatal Depression Scale (EPDS) total score
Time frame: up to day 31
Change from baseline in Hamilton Anxiety Rating Scale (HAM-A) total score
Time frame: up to day 31
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
gang Wang principal investigator
Beijing Anding Hospital, Capital Medical University
36 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MI078 capsule in people with Postpartum Depression (PPD), run by Nanjing Minova Pharmaceutical Co., Ltd. at 36 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 20 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: looking for participants now, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact cuixia zhang (025-86667819 ext. 833, zhangcuixia@mnvpharma.com), or a site near the patient. 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?
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 23 Jul 2026.