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The primary purpose of this study is to determine if treatment with HS-10353 reduces depressive symptoms in participants with postpartum depression (PPD) compared to placebo as assessed by the change from baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D17) total score at Day 15. And the secondary purpose of this study is to evaluate the safety and tolerability of HS-10353 compared to placebo as assessed by the incidence of adverse events, clinical laboratory evaluations, electrocardiogram (ECG) parameters, the Columbia Suicide Severity Rating Scale (C-SSRS), and the 20-item Physician Withdrawal Checklist (PWC-20).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HS-10353 Capsules | Experimental |
| |
| Placebo for HS-10353 Capsules | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HS-10353 Capsules 30 mg, Oral, QN for 14 days | Drug | HS-10353 Capsules 30 mg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the HAM-D17 total score at day 15 | The HAM-D17 is used to rate the severity of depression in participants who are already diagnosed as depressed. The HAM-D17 total score was calculated as the sum of the 17 individual item scores and could range from 0 to 52. Higher scores indicated more severe depression. A negative change from baseline indicates less depression | Baseline, Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the HAM-D Total Score at Days 3, 8, 21 and 28 | The HAM-D17 is used to rate the severity of depression in participants who are already diagnosed as depressed. The HAM-D17 total score was calculated as the sum of the 17 individual item scores and could range from 0 to 52. Higher scores indicated more severe depression. A negative change from baseline indicates less depression |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yun Chen | Contact | 18652105250 | cheny22@hspharm.com |
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| HS-10353 Capsules 50 mg, Oral, QN for 14 days |
| Drug |
HS-10353 Capsules 50 mg |
|
| HS-10353 Capsules matching placebo, 30mg, Oral, QN for 14 days. | Drug | Placebo |
|
| HS-10353 Capsules matching placebo, 50mg, Oral, QN for 14 days | Drug | Placebo |
|
| Baseline, Day 3, Day 8, Day 21, Day 28 |
| Percentage of Participants With HAM-D17 Response | HAM-D17 Response was defined as having a 50 percent (%) or greater reduction from Baseline in HAM-D17 total score. The HAM-D17 total score was calculated as the sum of the 17 individual item scores and could range from 0 to 52. Higher scores indicated more depression. | Baseline, Day 3, Day 8, Day 15, Day 21, Day 28 |
| Percentage of Participants With HAM-D17 Remission | HAM-D17 Remission was defined as a HAM-D17 total score of less than or equal to (<=)7. The HAM-D17 total score was calculated as the sum of the 17 individual item scores and could range from 0 to 52. | Baseline, Day 3, Day 8, Day 15, Day 21, Day 28 |
| Change From Baseline in the Clinical Global Impressions - Severity Scale (CGI-S) Total Score | The CGI-S is a 7-point Likert scale to rate the severity of the participant's illness at the time of assessment, relative to the clinician's past experience with participants who had the same diagnosis. A participant was assessed on severity of mental illness at the time of rating as 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; and 7= extremely ill participants. A lower score indicates a better outcome. A negative change from baseline indicates improvement. MMRM was used for the analysis | Baseline, Day 3, Day 8, Day 15, Day 21, Day 28 |
| Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response | The Clinical Global Impression - Improvement (CGI-I) item of the CGI scale uses a 7-point Likert scale to measure the overall improvement in the participant's condition posttreatment. The investigator rated the participant's total improvement whether or not it was due entirely to drug treatment. Response choices included: 0=not assessed, 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse. CGI response was defined as a CGI-I score of 1 (very much improved) or 2 (much improved). The percentage of participants with overall improvement in post-treatment condition, rated by investigator as very much improved (CGI-I score of 1) or much improved (CGI-I score of 2) is reported. | Baseline, Day 3, Day 8, Day 15, Day 21, Day 28 |
| Change From Baseline in Montgomery and Åsberg Depression Rating Scale (MADRS) Total Score | The MADRS is a 10-item questionnaire used to measure the severity of depressive episodes in participants with mood disorders. It includes questions on the following symptoms: apparent sadness; reported sadness; inner tension; reduced sleep; reduced appetite; concentration difficulties; lassitude; inability to feel; pessimistic thoughts; and suicidal thoughts. Each item was scored in a range of 0 (no symptoms) to 6 (symptoms of maximum severity). The MADRS total score was calculated as the sum of the 10 individual item scores and could range from 0 to 60. Higher scores indicated more severe depression. A negative change from Baseline indicates less depression. | Baseline, Day 3, Day 8, Day 15, Day 21, Day 28 |
| Change From Baseline in Self-Reported Measures of Depressive Symptoms, as Assessed by the Edinburgh Postnatal Depression Scale (EPDS) Total Score | The EPDS is a self-rated depressive symptom severity scale specific to the perinatal period which consists of 10 individual items. Each item is rated on a 4-point scale ranging from 0 to 3 points. The EPDS total score is calculated as the sum of the 10 individual item scores, ranging from 0 points to 30 points with a higher score indicating more depression. A negative change indicates improvement. | Baseline, Day 3, Day 8, Day 15, Day 21, Day 28 |
| Change From Baseline in Self-Reported Measures of Depressive Symptoms, as Assessed by the 9-item Patient Health Questionnaire (PHQ-9) Score | The PHQ-9 is a self-rated depressive symptom severity scale to monitor severity over time for newly diagnosed participants or participants in current treatment for depression. Scoring was based on participants responses to 9 specific questions as follows: 0 = not at all; 1 = several days; 2 = more than half the days; and 3 = nearly every day. The score were calculated as the sum of the 9 individual item scores. The PHQ-9 total score was categorized as follows: 1 to 4 = minimal depression, 5 to 9 = mild depression, 10 to 14 = moderate depression, 15 to 19 = moderately severe depression; and 20 to 27 = severe depression. The PHQ-9 total score ranges from 1 to 27 with a higher score indicating more depression. A negative change from baseline indicates reduced depression. MMRM was used for the analysis. | Baseline, Day 3, Day 8, Day 15, Day 21, Day 28 |
| Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score | The 14-item HAM-A was used to rate the severity of symptoms of anxiety. Each of the 14 items was defined by a series of symptoms and measured both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). The individual items were scored in a range of 0 (not present) to 4 (very severe). The HAM-A total score was calculated as the sum of the 14 individual item scores and could range from 0 to 56 where a score of <17=mild severity; 18-24= mild to moderate severity and 25-30=moderate to severe severity. A negative change from Baseline indicates less anxiety. | Baseline, Day 3, Day 8, Day 15, Day 21, Day 28 |
| Change From Baseline in (PWC-20) Total Score | Baseline, Day 15, Day 21 |
| Number of Participants With adverse events (AEs), serious adverse events (SAEs), and adverse events leading to withdrawal from the trial, and association with the investigational drug | An Adverse Event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE was defined as an AE with an onset that occurs after receiving study drug. | Up to Day 28 |
| Number of Participants With Potentially Clinically Significant Vital Sign Measurements | Vital signs included assessments of systolic blood pressure (SBP), diastolic blood pressure (DBP), temperature, respiration and heart rate. | Up to Day 28 |
| Number of Participants With Potentially Clinically Significant Laboratory Evaluations | ECG parameters included assessment of the standard 12-lead ECG intervals: QT, QTcF, PR, RR, QRS, and heart rate. Heart rate was measured in terms of beats per minute. Change from Baseline in heart rate, PR Interval, RR Interval, QRS Duration, QT Interval, QTcF Interval is reported. | Up to Day 28 |
| ID | Term |
|---|---|
| D019052 | Depression, Postpartum |
| ID | Term |
|---|---|
| D011644 | Puerperal Disorders |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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