Depression, PostpartumPhase 3BLOOMNCT07822321
Brexanolone Lifting Outcomes Of Moms
A Phase 3 study testing LPCN 1154A in people with Depression, Postpartum and Postpartum Depression (PPD), run by Lipocine Inc. at 16 sites in United States.
Trial summary
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: If LPCN 1154A reduces depressive symptoms in subjects with severe PPD How well LPCN 1154A is tolerated and what side effects it may cause Read more about this study
- Who is it for?
- Ages 15 to 45 years, women only
- Conditions the study is for
- Depression, Postpartum, Postpartum Depression (PPD), Post-partum Depression
- What is being tested?
- LPCN 1154A
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 16 sitesUnited States
- Study dates
- Sep 2026to Sep 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 15 to 45 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Are female between 15 and 45 years of age, inclusive;
- Have had a depressive episode that began no earlier than second trimester and no later than the first 4 weeks following delivery
- Are < 18 months postpartum at Screening
- Hamilton Depression Rating Scale (HAM-D) 17-item score indicative of severe depression
Who cannot join
- Have a history of bipolar disorder, schizophrenia or schizoaffective disorder
- Are currently experiencing active psychosis per Investigator assessment
- Have a history of suicidal behavior associated with the current depressive episode
- Have a history of seizure within six months of Screening
Trial locations and contacts
16 sites in 1 country. Contact the study team or a site near you to ask about taking part.
16 sites in 1 country
United States16 sites, 16 recruiting
- Recruiting
Lipocine Investigational Site
Aurora, Colorado, 80045
- Recruiting
Lipocine Investigational Site
Canoga Park, California, 91304
- Recruiting
Lipocine Investigational Site
Chapel Hill, North Carolina, 27514
- Recruiting
Lipocine Investigational Site
Chicago, Illinois, 60641
- Recruiting
Lipocine Investigational Site
Clinton, Utah, 84105
- Recruiting
Lipocine Investigational Site
Decatur, Georgia, 30030
- Recruiting
Lipocine Investigational Site
Idaho Falls, Idaho, 83402
- Recruiting
Lipocine Investigational Site
Las Vegas, Nevada, 89119
- Recruiting
Lipocine Investigational Site
Manhattan, New York, 10036
- Recruiting
Lipocine Investigational Site
New Orleans, Louisiana, 70115
- Recruiting
Lipocine Investigational Site
Orem, Utah, 84058
- Recruiting
Lipocine Investigational Site
Plano, Texas, 75093
- Recruiting
Lipocine Investigational Site
Princeton, New Jersey, 08540
- Recruiting
Lipocine Investigational Site
Richardson, Texas, 75080
- Recruiting
Lipocine Investigational Site
Tucson, Arizona, 85715
- Recruiting
Lipocine Investigational Site
Walnut Creek, California, 94596
About this study
Official title: A Randomized, Blinded, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Oral LPCN 1154A in Women With Postpartum Depression
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:
- If LPCN 1154A reduces depressive symptoms in subjects with severe PPD
- How well LPCN 1154A is tolerated and what side effects it may cause
- Conditions
- Depression, Postpartum, Postpartum Depression (PPD), Post-partum Depression, Postnatal Depression, Post-Natal Depression, Peripartum Depression
- Being tested
- LPCN 1154A, Placebo
- Keywords
- Postpartum Depression, PPD, Depression, LPCN 1154A, brexanolone, neuroactive steriod, GABAA
- 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.
LPCN 1154ADrug
Also called Brexanolone
Oral LPCN 1154A tablets for 48 hours
PlaceboDrug
Oral Placebo Tablets for 48 hours
| Study group | Role | What they receive |
|---|---|---|
| LPCN 1154A Tablets | Experimental | LPCN 1154A Tablets Receives: Drug: LPCN 1154A |
| 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.
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 activities, psychomotor retardation, psychomotor agitation, anxiety (psychic and somatic), gastrointestinal symptoms, general somatic symptoms, genital symptoms, hypochondriasis, insight, and weight loss. The total score ranges from 0 to 52, with higher scores indicating more severe depression.
Measured: Baseline to Hour 60
Secondary outcomes (2)
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 activities, psychomotor retardation, psychomotor agitation, anxiety (psychic and somatic), gastrointestinal symptoms, general somatic symptoms, genital symptoms, hypochondriasis, insight, and weight loss. The total score ranges from 0 to 52, with higher scores indicating more severe depression.
Measured: Baseline to Hour 12 and Day 30
Change from baseline Clinical Global Impression of Severity (CGI-S) scale positive response
The CGI-S scale is a 7-point scale that requires the Investigator to assess the severity of a patient's illness. Scores range from 1 -normal, not at all ill to 7 - among the most extremely ill patients
Measured: Baseline to Hour 12, Hour 60 and Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionSep 2027 (estimated)
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lipocine Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07822321
- Sponsor's protocol ID
- LPCN 1154-26-002
- Acronym
- BLOOM
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Blinded, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Oral LPCN 1154A in Women With Postpartum Depression
- ClinicalTrials.gov ID
- NCT07822321
- Acronym / sponsor ID
- BLOOM / LPCN 1154-26-002
- Conditions
- Depression, Postpartum, Postpartum Depression (PPD), Post-partum Depression, Postnatal Depression, Post-Natal Depression, Peripartum Depression
- Keywords
- Postpartum Depression, PPD, Depression, LPCN 1154A, brexanolone, neuroactive steriod, GABAA
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Lipocine Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 16 Sep 2026 (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, LPCN 1154A, as a possible treatment for postpartum depression (PPD). The trial aims to determine:
- If LPCN 1154A reduces depressive symptoms in subjects with severe PPD
- How well LPCN 1154A is tolerated and what side effects it may cause
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LPCN 1154A Tablets | Experimental | Drug: LPCN 1154ALPCN 1154A Tablets |
| Placebo Tablets | Placebo comparator | Drug: PlaceboPlacebo Tablets |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Are female between 15 and 45 years of age, inclusive;
- Have had a depressive episode that began no earlier than second trimester and no later than the first 4 weeks following delivery
- Are < 18 months postpartum at Screening
- Hamilton Depression Rating Scale (HAM-D) 17-item score indicative of severe depression
Key exclusion criteria (4 listed)
- Have a history of bipolar disorder, schizophrenia or schizoaffective disorder
- Are currently experiencing active psychosis per Investigator assessment
- Have a history of suicidal behavior associated with the current depressive episode
- Have a history of seizure within six months of Screening
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 |
|---|---|---|
| LPCN 1154AAlso: BrexanoloneOral LPCN 1154A tablets for 48 hours | Drug | LPCN 1154A Tablets |
| PlaceboOral Placebo Tablets for 48 hours | Drug | Placebo Tablets |
Primary outcome
Change from baseline in HAM-D17 total score compared to placebo
Time frame: Baseline to Hour 60
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 activities, psychomotor retardation, psychomotor agitation, anxiety (psychic and somatic), gastrointestinal symptoms, general somatic symptoms, genital symptoms, hypochondriasis, insight, and weight loss. The total score ranges from 0 to 52, with higher scores indicating more severe depression.
2 secondary outcomes
Change from baseline in HAM-D17 total score
Time frame: Baseline to Hour 12 and Day 30
Change from baseline Clinical Global Impression of Severity (CGI-S) scale positive response
Time frame: Baseline to Hour 12, Hour 60 and Day 30
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 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.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing LPCN 1154A in people with Depression, Postpartum and Postpartum Depression (PPD), run by Lipocine Inc. at 16 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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vice President of Clinical Development (801-519-4363 ext. 2116, siteinquiry@lipocine.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in HAM-D17 total score compared to placebo (time frame: Baseline to Hour 60). 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 16 Sep 2026.