Postpartum Depression (PPD)
Conditions
Brief 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.
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.
Interventions
DRUGMI078 capsule
MI078 capsule for 3 days
DRUGPlacebo of MI078 capsules
Placebo for 3days
Sponsors
Nanjing Minova Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in HAM-D17 total score | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in the CGI-S score | up to day 31 | 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 |
| HAM-D17 response | up to day 31 | 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. |
| HAM-D17 remission | up to day 31 | Defined as having a HAM-D17 total score ≤7. The total score ranges from 0 to 52, with higher scores indicating more severe depression |
| Clinical Global Impression - Improvement (CGI-I) scale positive response | up to day 31 | 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 |
| Change from baseline in MADRS total score | up to day 31 | 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 |
| Change from baseline in Edinburgh Postnatal Depression Scale (EPDS) total score | up to day 31 | 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. |
| Change from baseline in Hamilton Anxiety Rating Scale (HAM-A) total score | up to day 31 | 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. |
Countries
China
Contacts
CONTACTcuixia zhang
PRINCIPAL_INVESTIGATORgang Wang
Beijing Anding Hospital, Capital Medical University
Outcome results
None listed