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This is a study evaluating the efficacy, and safety of KH607 in 72 participants diagnosed with Postpartum Depressive Disorder.
The study is a randomized, double-blind, parallel-group, placebo-controlled design. Eligible participants were randomized to KH607 group or placebo group for 14 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KH607 | Experimental | Participants receive KH607, 30 milligrams (mg), oral tablets, once daily for 14 days, as tolerated. |
|
| Placebo | Placebo Comparator | Eligible participants receive matching placebo tablets once daily for 14 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KH607 tablet | Drug | oral，once daily for 14 days |
| |
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D17) Total Score at Day 15 | The HAM-D total score comprised a sum of 17 individual item scores.The total score could range from 0 to 52. Higher scores indicated a greater degree of depression. | Baseline, Day15 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D17) Total Score at all other time points | Day3,8,21 and 28 | |
| Change From Baseline in the Montgomery and Åsberg Depression Rating Scale (MADRS) Total Score at Day 15 and All Other Time Points |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gang Wang, Medical Doctor | Contact | 86-010-58303063 | adgangwang@163.com | |
| Xue Wang, Medical Doctor | Contact | 86-010-58303063 | xuew37@aliyun.com |
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| Drug |
oral，once daily for 14 days |
|
The MADRS was a ten-item diagnostic questionnaire which psychiatrists used to measure the severity of depressive episodes in participants with mood disorders. It was designed as an adjunct to the HAM-D, to be more sensitive than the Hamilton Scale to the changes brought on by antidepressants and other forms of treatment. Each item yielded a score of 0 to 6. The MADRS total score was calculated as the sum of the 10 individual item scores, which ranged from 0 to 60. Higher MADRS scores indicated more severe depression. A negative change from baseline indicated less severe depression. A positive change from baseline indicated more severe depression. The analysis was performed in participants included in Part A of the study.
| Day 3,8,15,21 and 28 |
| Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score at All Time Points | 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). Scoring for HAM-A was calculated by assigning scores of 0 (not present) to 4 (very severe), with a total score range of 0 to 56. The HAM-A total score was calculated as the sum of the 14 individual item scores. A negative change from baseline indicated less anxiety. A positive change from baseline indicated more anxiety. The analysis was performed in participants included in Part A of the study. | Day 3,8,15,21 and 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. | Day 3,8,15,21 and 28 |
| Percentage of Participants With Clinical Global Impression - Severity (CGI-S) Response | The CGI-S item employed a 7-point Likert scale to measure the overall severtity in the participant's condition. | Day 3,8,15,21 and 28 |
| Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response | The CGI-I item employed a 7-point Likert scale to measure the overall improvement in the participant's condition post-treatment. The investigator rated the participant's total improvement whether or not it was due entirely to drug treatment. The CGI-I was only rated at post-treatment assessments. By definition, all CGI-I assessments were evaluated against baseline conditions. CGI-I response was defined as having a CGI-I global improvement score of 1 (very much improved) or 2 (much improved). The analysis was performed in participants included in Part A of the study. Data is reported for participants who had CGI-I response. | Day 3,8,15,21 and 28 |
| Percentage of Participants With HAM-D Response | HAM-D response was defined as having a 50% or greater reduction from baseline in HAM-D total score. The analysis was performed in participants included in Part A of the study. Data is reported for participants who had HAM-D response. | Day 3,8,15,21 and 28 |
| Percentage of Participants With HAM-D Remission | HAM-D remission was defined as having a HAM-D total score of ≤7. The analysis was performed in participants included in Part A of the study. | Day 3,8,15,21 and 28 |