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The purpose of this research study is to test the study drug, NORA520, as a possible treatment for severe postpartum depression (PPD). The trial aims to determine:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NORA520 Tablets Dose 1 | Experimental | NORA520 Tablets Dose 1 |
|
| NORA520 Tablets Dose 2 | Experimental | NORA520 Tablets Dose 2 |
|
| Placebo Tablets | Placebo Comparator | Placebo Tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NORA520 Dose 1 | Drug | Oral NORA520 tablets Dose 1 for 3 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence, severity, and causality of AEs, SAEs, and AESIs | Adverse events (AEs), Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) | Up to Day 30 |
| 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 Day 4 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pillar Clinical Research | Bentonville | Arkansas | 72712 | United States | ||
| Advanced Research Center |
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| NORA520 Dose 2 |
| Drug |
Oral NORA520 tablets Dose 2 for 3 days |
|
| Placebo | Drug | Oral Placebo tablets for 3 days |
|
| Baseline to Days 8 and 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 Days 4, 8, and 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. | Baseline to Days 4, 8, and 30 |
| Change from baseline in HAM-D17 subscale and individual item scores | 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 Days 4, 8, and 30 |
| Change from baseline in Clinical Global Impression - Severity (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. | Baseline to Days 4, 8, and 30 |
| 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 | Baseline to Days 4, 8, and 30 |
| Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score | The MADRS contains 10 individual items related to the following symptoms: apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. The total score ranges from 0 to 60, with higher scores indicating more severe depression. | Baseline to Days 4, 8, and 30 |
| Change from baseline in Hamilton Anxiety Rating Scale (HAM-A) total score | The HAM-A contains 14 individual ratings related to the following symptoms: anxious mood, tension, fears, insomnia, intellectual, depressed mood, somatic (muscular), somatic (sensory), cardiovascular symptoms, respiratory symptoms, gastrointestinal symptoms, genitourinary symptoms, autonomic symptoms, and behavior at interview. The total score ranges from 0 to 56, with higher scores indicating more severe anxiety. | Baseline to Days 4, 8, and 30 |
| Change from baseline in Edinburgh Postnatal Depression Scale (EPDS) total score | The Edinburgh Postnatal Depression Scale (EPDS) is a set of 10 screening questions. The total score ranges from 0 to 30, with higher scores indicating more severe depression. | Baseline to Days 8 and 30 |
| Number of patients who start any new antidepressant or anti-anxiety medication | After Day 8 assessments through Day 30 |
| Anaheim |
| California |
| 92805 |
| United States |
| Alliance Research Institute | Canoga Park | California | 91304 | United States |
| Cenexel Clinical Research | Sherman Oaks | California | 91403 | United States |
| Cenexel Clinical Research | Torrance | California | 90504 | United States |
| MedOne Clinical Research | Miami | Florida | 33145 | United States |
| Meridian International Research, Inc. | Miami Gardens | Florida | 33014 | United States |
| Combined Research | Orlando | Florida | 32807 | United States |
| Clinical Research Center of Florida | Pompano Beach | Florida | 33060 | United States |
| GCP Research | St. Petersburg | Florida | 33607 | United States |
| Cenexel Clinical Research | Atlanta | Georgia | 30331 | United States |
| CenExel Clinical Research | Decatur | Georgia | 30030 | United States |
| CenExel Clinical Research | Savannah | Georgia | 31405 | United States |
| Insight Hospital and Medical Center Chicago | Chicago | Illinois | 60616 | United States |
| Zucker Hillside Hospital | Glen Oaks | New York | 11004 | United States |
| Monroe Biomedical Research | Monroe | North Carolina | 28112 | United States |
| Maximos Ob/Gyn | League City | Texas | 77573 | United States |
| Pillar Clinical Researc | Richardson | Texas | 75080 | United States |
| ID | Term |
|---|---|
| D019052 | Depression, Postpartum |
| D003863 | Depression |
| 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 |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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