Depression, PostpartumPhase 2NuMomNCT06285916
A Study to Assess the Efficacy, Safety, and Tolerability of Oral NORA520 in Adults With Severe Postpartum Depression
A Phase 2 study testing NORA520 Dose 1 and NORA520 Dose 2 in people with Depression, Postpartum and Postpartum Depression, run by TWi Biotechnology, Inc. at 18 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Depression, Postpartum, Postpartum Depression, Post-partum Depression
- What is being tested?
- NORA520 Dose 1 and NORA520 Dose 2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 93 participants
- Where
- 18 sitesUnited States
- Study dates
- 28 Mar 2024to 6 Oct 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Advanced Research Center
Anaheim, California, 92805
Cenexel Clinical Research
Atlanta, Georgia, 30331
Pillar Clinical Research
Bentonville, Arkansas, 72712
Alliance Research Institute
Canoga Park, California, 91304
Insight Hospital and Medical Center Chicago
Chicago, Illinois, 60616
CenExel Clinical Research
Decatur, Georgia, 30030
Zucker Hillside Hospital
Glen Oaks, New York, 11004
Maximos Ob/Gyn
League City, Texas, 77573
MedOne Clinical Research
Miami, Florida, 33145
Meridian International Research, Inc.
Miami Gardens, Florida, 33014
Monroe Biomedical Research
Monroe, North Carolina, 28112
Combined Research
Orlando, Florida, 32807
Clinical Research Center of Florida
Pompano Beach, Florida, 33060
Pillar Clinical Researc
Richardson, Texas, 75080
CenExel Clinical Research
Savannah, Georgia, 31405
Cenexel Clinical Research
Sherman Oaks, California, 91403
GCP Research
St. Petersburg, Florida, 33607
Cenexel Clinical Research
Torrance, California, 90504
About this study
Official title: A Randomized, Placebo-Controlled, Double-Blinded, Phase 2 Study to Evaluate the Efficacy, Safety, and Tolerability of Oral NORA520 in Female Adults With Severe Postpartum Depression
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.
- Conditions
- Depression, Postpartum, Postpartum Depression, Post-partum Depression, Postnatal Depression, Post-Natal Depression
- Being tested
- NORA520 Dose 1, NORA520 Dose 2, Placebo
- Keywords
- Depression, Postpartum Depression, NORA520, Postnatal Depression, NuMom
- Medical subject headings
- Depression, Postpartum, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NORA520 Dose 1Drug
Oral NORA520 tablets Dose 1 for 3 days
NORA520 Dose 2Drug
Oral NORA520 tablets Dose 2 for 3 days
PlaceboDrug
Oral Placebo tablets for 3 days
| Study group | Role | What they receive |
|---|---|---|
| NORA520 Tablets Dose 1 | Experimental | NORA520 Tablets Dose 1 Receives: Drug: NORA520 Dose 1 |
| NORA520 Tablets Dose 2 | Experimental | NORA520 Tablets Dose 2 Receives: Drug: NORA520 Dose 2 |
| Placebo Tablets | Placebo comparator | Placebo Tablets Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence, severity, and causality of AEs, SAEs, and AESIs
Adverse events (AEs), Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs)
Measured: 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.
Measured: Baseline to Day 4
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to Days 8 and 30
Number of patients who start any new antidepressant or anti-anxiety medication
Measured: After Day 8 assessments through Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start28 Mar 2024
- Primary completion11 Sep 2025
- Study completion6 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression, PostpartumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- TWi Biotechnology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06285916
- Sponsor's protocol ID
- NORA520-PT-US-1a
- Acronym
- NuMom
- Status last verified
- Nov 2025
- First submitted
- 17 Feb 2024
- Last updated
- 31 Jul 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled, Double-Blinded, Phase 2 Study to Evaluate the Efficacy, Safety, and Tolerability of Oral NORA520 in Female Adults With Severe Postpartum Depression
- ClinicalTrials.gov ID
- NCT06285916
- Acronym / sponsor ID
- NuMom / NORA520-PT-US-1a
- Conditions
- Depression, Postpartum, Postpartum Depression, Post-partum Depression, Postnatal Depression, Post-Natal Depression
- Keywords
- Depression, Postpartum Depression, NORA520, Postnatal Depression, NuMom
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- TWi Biotechnology, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Mar 2024 (actual)
- Primary completion
- 11 Sep 2025 (actual)
- Study completion
- 6 Oct 2025 (actual)
- First posted
- 29 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NORA520 Tablets Dose 1 | Experimental | Drug: NORA520 Dose 1NORA520 Tablets Dose 1 |
| NORA520 Tablets Dose 2 | Experimental | Drug: NORA520 Dose 2NORA520 Tablets Dose 2 |
| Placebo Tablets | Placebo comparator | Drug: PlaceboPlacebo Tablets |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NORA520 Dose 1Oral NORA520 tablets Dose 1 for 3 days | Drug | NORA520 Tablets Dose 1 |
| NORA520 Dose 2Oral NORA520 tablets Dose 2 for 3 days | Drug | NORA520 Tablets Dose 2 |
| PlaceboOral Placebo tablets for 3 days | Drug | Placebo Tablets |
Primary outcome
Incidence, severity, and causality of AEs, SAEs, and AESIs
Time frame: 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
Time frame: 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.
10 secondary outcomes
Change from baseline in HAM-D17 total score
Time frame: Baseline to Days 8 and 30
HAM-D17 response
Time frame: Baseline to Days 4, 8, and 30
HAM-D17 remission
Time frame: Baseline to Days 4, 8, and 30
Change from baseline in HAM-D17 subscale and individual item scores
Time frame: Baseline to Days 4, 8, and 30
Change from baseline in Clinical Global Impression - Severity (CGI-S) score
Time frame: Baseline to Days 4, 8, and 30
Clinical Global Impression - Improvement (CGI-I) scale positive response
Time frame: Baseline to Days 4, 8, and 30
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score
Time frame: Baseline to Days 4, 8, and 30
Change from baseline in Hamilton Anxiety Rating Scale (HAM-A) total score
Time frame: Baseline to Days 4, 8, and 30
Change from baseline in Edinburgh Postnatal Depression Scale (EPDS) total score
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NORA520 Dose 1 and NORA520 Dose 2 in people with Depression, Postpartum and Postpartum Depression, run by TWi Biotechnology, Inc. at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence, severity, and causality of AEs, SAEs, and AESIs (time frame: Up to Day 30). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.