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New treatment option for Postpartum Depression (PPD)
Official title A Study of MI078 for Postpartum Depression
ClinicalTrials.gov ID: NCT07721961
What this study is testing
What is MI078 capsule?
MI078 capsule is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for postpartum depression (ppd).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45, women only
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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...
- Meeting diagnostic criteria for treatment-resistant depression.
- Continuous use of therapeutic doses of antidepressants for more than 14 days during the current episode.
See the full eligibility 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...
- 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.
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, China
- Chongqing, Chongqing Municipality, China
- Xiamen, Fujian, China
- Lanzhou, Gansu, China
- Guangzhou, Guangdong, China
- Zhaoqing, Guangdong, China
- Liuzhou, Guangxi, China
- Guiyang, Guizhou, China
- Zunyi, Guizhou, China
- Haikou, Hainan, China
- Shijiazhuang, Hebei, China
- Shiyan, Hebei, China
- Xingtai, Hebei, China
- Xinxiang, Henan, China
- Zhengzhou, Henan, China
- Zhumadian, Henan, China
- Wuhan, Hubei, China
- Changsha, Hunan, China
- Zhuzhou, Hunan, China
- Wuxi, Jiangsu, China
+ 11 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 45 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, Anhui, China; Chongqing, Chongqing Municipality, China; Xiamen, Fujian, China; Lanzhou, Gansu, China; Guangzhou, Guangdong, China; Zhaoqing, Guangdong, China and 25 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.