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The purpose of this study is to learn about:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Dose PRT042 nasal spray | Experimental |
| |
| median Dose PRT042 nasal spray | Experimental |
| |
| high Dose PRT042 nasal spray | Experimental |
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| placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low Dose PRT042 nasal spray | Drug | two times a week, for 4 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score at 24 Hours After the First Dose (Day 2) | The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The test consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total score of 60. Higher scores represent a more severe condition. | Baseline (Day 1, predose) and 24 hours first post dose (Day 2) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Montgomery Asberg Depression Rating Scale Total Score During Double-blind Phase | The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The test consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total score of 60. Higher scores represent a more severe condition. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ke yao | Contact | 86-028-85170738 | ke.yao@btyy.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BEIjing AnDing hospital capital medical university | Recruiting | Beijing | China |
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| median Dose PRT042 nasal spray |
| Drug |
two times a week, for 4 weeks |
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| high dose PRT042 nasal spray | Drug | two times a week, for 4 weeks |
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| placebo | Drug | two times a week, for 4 weeks |
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| Days 1 (4 hours postdose), 4, 8, 11, 15, 18, 22 and Day 25 |
| Number of Participants who Achieved Response （≥50% decrease from baseline MADRS total score）Through the Double-blind Phase | Days 1 (4 hours postdose),2, 4, 8, 11, 15, 18, 22 and Day 25 |
| Number of Participants Who Achieved Remission (MADRS Total Score Less Than or Equal to [<=] 12) Through the Double-blind Phase | Days 1 (4 hours postdose), 2, 4, 8, 11, 15, 18, 22 and Day 25 |
| 5. Change From Baseline in Clinical Global Impression- Severity of Suicidality-Revised (CGI-SS-R) During Double-blind Phase | CGI-SS-R was derived from the Clinical Global Impression Severity Scale (CGI-S), a global rating scale that gives an overall measure of the severity of a participants illness. The CGI-SS-R rating is scored on a 7-point scale from 0 (normal, not at all suicidal) to 6 (among the most extremely suicidal participants). A higher score indicates a more severe condition and a reduction in score indicates improvement (that is, lower severity of suicidality). | Days 1 (4 hours postdose), 2, 4, 8, 11, 15, 18, 22 and Day 25 |
| Number of Participants Who Achieved Resolution of Suicidality (CGI-SS-R Score of 0 or 1) Through Double-blind Phase | up to Day 25 |
| Change From Baseline in Clinical Global Impression of Imminent Suicide Risk (CGI-SR-I) Scale Total Score During Double-blind Phase | The CGI-SR-I is a scale summarizing the clinician's best assessment of the likelihood that the participant will attempt suicide in the next 7 days. The CGI-SR-I rating is scored on a 7-point scale: where' 0 (no imminent suicide risk); 1 (minimal imminent suicide risk), 2 (mild imminent suicide risk), 3 (moderate imminent suicide risk), 4 (marked imminent suicide risk), 5 (severely imminent suicide risk), 6 (extreme imminent suicide risk). Higher score indicates a more severe condition. Negative change in score indicates improvement. | Days 1 (4 hours postdose), 2, 4, 8, 11, 15, 18, 22 and Day 25 |
| 8. Change From Baseline in Beck Hopelessness Scale (BHS) Total Score During Double-blind Phase | BHS is a self-reported measure to assess one's level of negative expectations or pessimism regarding future. It consists of 20 true-false items that examine respondent's attitude over past week by either endorsing a pessimistic statement or denying an optimistic statement; 9 are keyed false and 11 are keyed true. For every statement, each response was assigned score of 0 or 1. Total BHS score is sum of item responses, ranged from 0-20, where higher score represented higher level of hopelessness. | Baseline, Days 8 ,15 and 25 |
| Change From Baseline in Beck Scale for Suicide Ideation -Chinese Version (BSI-CV) Total Score During Double-blind Phase | BSI-CV is a self-reported measure with 19 items, scored on a 3-point scale (0 to 2). The final score ranges from 0 to 38, with higher scores indicating a greater likelihood of suicide. | Baseline, Days 8 ,15 and 25 |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs)、Vital Signs Abnormalities、Abnormal Electrocardiogram (ECG) Values et al: DB Treatment Phase | up to Day 25 |
| Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) | up to Day 25 |
| Maximum Plasma Concentration [Cmax] | up to Day 25 |
| plasma elimination half-life [T1/2] | up to Day 25 |
| Beijing AnDing hospital capital medical university | Recruiting | Beijing | China |
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| Beijing Huilongguan Hospital | Recruiting | Beijing | China |
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| The Fourth People's Hospital of Chengdu | Recruiting | Chengdu | China |
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| Hangzhou Seventh People's Hospital | Recruiting | Hangzhou | China |
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| The fourth affiliated hospital of Anhui medical university | Recruiting | Hefei | China |
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| The affiliated Kangning Hospital of Ningbo University | Recruiting | Ningbo | China |
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| Suzhou Guangji Hospital | Recruiting | Suzhou | China |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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