A Study of MI078 for Postpartum Depression
ConditionPostpartum Depression (PPD)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorNanjing Minova Pharmaceutical Co., Ltd.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
MI078 capsule
DrugMI078 capsule for 3 days
Placebo of MI078 capsules
DrugPlacebo for 3days
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: MI078 capsuleExperimental treatment 1 intervention
Group B: placeboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
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.
Time frame
up to day 31Secondary outcomes
1
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
Time frame
up to day 312
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.
Time frame
up to day 313
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
Time frame
up to day 314
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
Time frame
up to day 31Other outcomes
1
Number of participants with treatment-emergent adverse events (TEAEs)
Adverse events (AEs) will be assessed by type, frequency, severity, and relationship to study drug.
Time frame
up to day 312
Number of participants with Serious Adverse Events (SAEs)
As defined by ICH-GCP guidelines
Time frame
up to day 313
Change from baseline in PR interval，QRS duration, QT interval and Fridericia-corrected QT interval (QTcF)
The PR interval ,QRS duration, and QT interval will be measured from the 12-lead electrocardiogram (ECG) and reported in milliseconds (ms),The QT interval corrected for heart rate using Fridericia's formula (QTcF) will be derived from the 12-lead electrocardiogram (ECG) and reported in milliseconds (ms)
Time frame
up to day 314
Number of participants with suicidal ideation or behavior as assessed by C-SSRS
The Columbia-Suicide Severity Rating Scale (C-SSRS) will be used to evaluate suicidal ideation and behavior
Time frame
up to day 31Sponsors and contacts
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Source ClinicalTrials.gov