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The purpose of this research study is to test the study drug, LPCN 1154A, as a possible treatment for postpartum depression (PPD). The trial aims to determine:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LPCN 1154A Tablets | Experimental | LPCN 1154A |
|
| Placebo Tablets | Placebo Comparator | Placebo Tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LPCN 1154A | Drug | Oral LPCN 1154A tablets for 48 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in HAM-D17 total score compared to placebo | 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. | Baseline to Hour 60 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence, severity, and causality of AEs and SAEs | Adverse events (AEs) and Serious Adverse Events (SAEs) | upto Day 30 |
| Change from baseline in HAM-D17 total score | The Seventeen-Item Hamilton Rating Scale for Depression (HAM-D17) evaluates mood, suicide, work and interests, retardation, agitation, gastrointestinal symptoms, somatic symptoms, hypochondriasis, body weight and insight The total score ranges from 0 to 52, with higher scores indicating more severe depression. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advanced Research Center | Anahiem | California | 92805 | United States | ||
| Alliance Research Institute |
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| Placebo | Drug | Oral Placebo Tablets for 48 hours |
|
| Baseline at Hours 12, and 36, Day 7 and Day 30 |
| 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. | Baseline to Hours 12, and 36, 60, Day 7 and Day 30 |
| 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. | Hours 12, and 36, 60, Day 7 and Day 30 |
| Patient Global Impression - Change (PGI-C) scale positive response | The PGI-C scale is a 7-point scale that ranges from "1-very much better" to "7-very much worse" that allows participants to self- report their perception of improvement or decline of overall symptoms since starting treatment. | Hours 12, and 36, 60, Day 7 and Day 30 |
| Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score | The MADRS is a 10-item assessment that evaluates mood/thoughts, sleep, appetite, tension, concentration The total score ranges from 0 to 60, with higher scores indicating more severe depression. | Baseline to Hour 60 and Day 30 |
| Change from baseline in Hamilton Anxiety Rating Scale (HAM-A) total score | The HAM-A is a 14-item assessment that evaluates mood, tension, fear, memory/concentration, sleep, and physical symptoms affecting somatic, sensory, respiratory, cardiovascular, gastrointestinal, genitourinary, and autoimmune systems as it relates to anxiety. The total score ranges from 0 to 56, with higher scores indicating more severe anxiety. | Baseline to Hours 12, 36, 60 Day 7 and Day 30 |
| Canoga Park |
| California |
| 91304 |
| United States |
| MedOne Clinical Research, LLC | Miami | Florida | 33145 | United States |
| D&H National Research Centers | Miami | Florida | 33155 | United States |
| Meridian International Research | Miami Gardens | Florida | 33014 | United States |
| Atlanta Behavioral Research | Atlanta | Georgia | 30338 | United States |
| CenExel Research Center | Decatur | Georgia | 30030 | United States |
| CenExel Research Center | Savannah | Georgia | 31405 | United States |
| Clinical Research Prime | Idaho Falls | Idaho | 83404 | United States |
| Cypress Medical Research Center, LLC | Kansas City | Kansas | 67226 | United States |
| Best Clinical Trials | New Orleans | Louisiana | 70115 | United States |
| Oasis Clinical Research | Las Vegas | Nevada | 89121 | United States |
| Monroe Biomedical Research | Monroe | North Carolina | 28112 | United States |
| Suburban Research Associates | Media | Pennsylvania | 19063 | United States |
| Gadolin Research | Beaumont | Texas | 77702 | United States |
| New Dawn Wellness and Medical Center | Houston | Texas | 77082 | United States |
| Maximos OB/GYN | League City | Texas | 77573 | United States |
| Populace Research | Provo | Utah | 84604 | United States |
| 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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| ID | Term |
|---|---|
| C000625635 | brexanolone |
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