A Phase 2 interventional study of NORA520 Dose 1 and NORA520 Dose 2 in Depression, Postpartum, Postpartum Depression and Post-partum Depression, sponsored by TWi Biotechnology, Inc.. Completed at 18 sites in United States. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-07-31.
Sponsored by TWi Biotechnology, Inc. · Phase 2, Interventional, and Treatment
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:
Key Inclusion Criteria:
Key Exclusion Criteria:
NORA520 Tablets Dose 1
Drug: NORA520 Dose 1
NORA520 Tablets Dose 2
Drug: NORA520 Dose 2
Placebo Tablets
Drug: Placebo
Oral NORA520 tablets Dose 1 for 3 days
Oral NORA520 tablets Dose 2 for 3 days
Oral Placebo tablets for 3 days
Incidence, severity, and causality of AEs, SAEs, and AESIs
Adverse events (AEs), Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs)
Time frame: 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.
Time frame: Baseline to Day 4
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to Days 8 and 30
Number of patients who start any new antidepressant or anti-anxiety medication
Time frame: After Day 8 assessments through Day 30
Plan to share: No
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TWi Biotechnology, Inc.