Depression, Postpartum, Postnatal Depression, Post-Natal Depression, Post-partum Depression, Postpartum Depression
Conditions
Keywords
Depression, Postpartum Depression, NORA520, Postnatal Depression, NuMom
Brief summary
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: * How well NORA520 is tolerated and what side effects it may cause * If NORA520 reduces depressive symptoms in subjects with severe PPD * The amount of NORA520 in the blood at various times after taking the study drug; this provides information that helps determine how often NORA520 should be taken * In a subset of subjects, the amount of NORA520 in breastmilk at various times after taking it to determine if and how much NORA520 can pass into breastmilk Participate in this study will be randomly assigned to one of 3 different groups. All subjects will take the study drug for 3 days.
Interventions
DRUGNORA520 Dose 1
Oral NORA520 tablets Dose 1 for 3 days
DRUGNORA520 Dose 2
Oral NORA520 tablets Dose 2 for 3 days
DRUGPlacebo
Oral Placebo tablets for 3 days
Sponsors
TWi Biotechnology, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Are willing and able to provide signed informed consent to participate in the study and to comply with all study procedures and scheduled visits * Are an adult female between 18 and 45 years of age, inclusive; * Have either ceased lactating at Screening, or if still lactating or actively breastfeeding at Screening, agree to temporarily cease giving breastmilk to their infant(s) from just prior to first dose of study drug on Day 1 through Day 14; * Have a negative pregnancy test at Screening and Day 1 (prior to dosing); * Have had a depressive episode that began no earlier than the third trimester and no later than the first 4 weeks following delivery * Are ≤9 months postpartum at Screening. Key
Exclusion criteria
* Have a history or current diagnosis or current treatment of bipolar disorder, schizophrenia, or schizoaffective disorder; * Have had recorded treatment failure of ≥2 different antidepressant classes (e.g., SSRI, SNRI) in the current or previous episode; * Are currently experiencing active psychosis per Investigator assessment, or are taking typical or atypical antipsychotic medication; * Have a history of suicidal behavior within 2 years; * Have a history or current diagnosis of sleep apnea or narcolepsy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence, severity, and causality of AEs, SAEs, and AESIs | Up to Day 30 | Adverse events (AEs), Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) |
| Change from baseline in HAM-D17 total score compared to placebo | Baseline to Day 4 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in HAM-D17 total score | Baseline to Days 8 and 30 | 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. |
| HAM-D17 response | Baseline to Days 4, 8, and 30 | 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. |
| HAM-D17 remission | Baseline to Days 4, 8, and 30 | Defined as having a HAM-D17 total score ≤7. The total score ranges from 0 to 52, with higher scores indicating more severe depression. |
| Change from baseline in HAM-D17 subscale and individual item scores | Baseline to Days 4, 8, and 30 | 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. |
| Change from baseline in Clinical Global Impression - Severity (CGI-S) score | Baseline to Days 4, 8, and 30 | 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. |
| Clinical Global Impression - Improvement (CGI-I) scale positive response | Baseline to Days 4, 8, and 30 | 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 |
| Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score | Baseline to Days 4, 8, and 30 | 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. |
| Change from baseline in Hamilton Anxiety Rating Scale (HAM-A) total score | Baseline to Days 4, 8, and 30 | 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. |
| Change from baseline in Edinburgh Postnatal Depression Scale (EPDS) total score | Baseline to Days 8 and 30 | 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. |
| Number of patients who start any new antidepressant or anti-anxiety medication | After Day 8 assessments through Day 30 | — |
Countries
United States
Outcome results
None listed