Depression, PostpartumPhase 3NCT06979544
A Study to Assess the Safety and Efficacy of Oral LPCN 1154A in Women With Severe PPD
A Phase 3 study testing LPCN 1154A in people with Depression, Postpartum and Depression, Post-Partum, run by Lipocine Inc. at 18 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 If LPCN 1154A reduces… Read more about this study
- Who is it for?
- Ages 15 to 45 years, women only
- Conditions the study is for
- Depression, Postpartum, Depression, Post-Partum, Postpartum Depression (PPD)
- 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
- 90 participants
- Where
- 18 sitesUnited States
- Study dates
- 16 Jun 2025to 17 Feb 2026
- Phase
- Phase 3
- 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 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 third trimester and later than the first 4 week following delivery
- Are < 12 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 within 1 year
- Have a history of seizure within 6 months of Screening
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Advanced Research Center
Anahiem, California, 92805
Atlanta Behavioral Research
Atlanta, Georgia, 30338
Gadolin Research
Beaumont, Texas, 77702
Alliance Research Institute
Canoga Park, California, 91304
CenExel Research Center
Decatur, Georgia, 30030
New Dawn Wellness and Medical Center
Houston, Texas, 77082
Clinical Research Prime
Idaho Falls, Idaho, 83404
Cypress Medical Research Center, LLC
Kansas City, Kansas, 67226
Oasis Clinical Research
Las Vegas, Nevada, 89121
Maximos OB/GYN
League City, Texas, 77573
Suburban Research Associates
Media, Pennsylvania, 19063
MedOne Clinical Research, LLC
Miami, Florida, 33145
D&H National Research Centers
Miami, Florida, 33155
Meridian International Research
Miami Gardens, Florida, 33014
Monroe Biomedical Research
Monroe, North Carolina, 28112
Best Clinical Trials
New Orleans, Louisiana, 70115
Populace Research
Provo, Utah, 84604
CenExel Research Center
Savannah, Georgia, 31405
About this study
Official title: A Randomized, Blinded, Placebo-Controlled Study to Evaluate the Saftey 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
- If LPCN 1154A reduces anxiety symptoms in subjects with severe PPD
- Conditions
- Depression, Postpartum, Depression, Post-Partum, Postpartum Depression (PPD), Post-Natal Depression, Peripartum Depression, Postnatal Depression
- Being tested
- LPCN 1154A, Placebo
- Medical subject headings
- Depression, Postpartum
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 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 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 Hour 60
Secondary outcomes (7)
Incidence, severity, and causality of AEs and SAEs
Adverse events (AEs) and Serious Adverse Events (SAEs)
Measured: upto Day 30
Change from baseline in HAM-D17 total score
The Seventeen-Item Hamilton Rating Scale for Depression (HAM-D17) evaluates mood, suicide, work and interests, retardation, agitation, gastrointestinal symptoms, somatic symptoms, hypochondriasis, body weight and insight The total score ranges from 0 to 52, with higher scores indicating more severe depression.
Measured: Baseline at Hours 12, and 36, Day 7 and Day 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 Hours 12, and 36, 60, Day 7 and Day 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: Hours 12, and 36, 60, Day 7 and Day 30
Patient Global Impression - Change (PGI-C) scale positive response
The PGI-C scale is a 7-point scale that ranges from "1-very much better" to "7-very much worse" that allows participants to self- report their perception of improvement or decline of overall symptoms since starting treatment.
Measured: Hours 12, and 36, 60, Day 7 and Day 30
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score
The MADRS is a 10-item assessment that evaluates mood/thoughts, sleep, appetite, tension, concentration The total score ranges from 0 to 60, with higher scores indicating more severe depression.
Measured: Baseline to Hour 60 and Day 30
Change from baseline in Hamilton Anxiety Rating Scale (HAM-A) total score
The HAM-A is a 14-item assessment that evaluates mood, tension, fear, memory/concentration, sleep, and physical symptoms affecting somatic, sensory, respiratory, cardiovascular, gastrointestinal, genitourinary, and autoimmune systems as it relates to anxiety. The total score ranges from 0 to 56, with higher scores indicating more severe anxiety.
Measured: Baseline to Hours 12, 36, 60 Day 7 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 posted20 May 2025
- Study start16 Jun 2025
- Primary completion16 Jan 2026
- Study completion17 Feb 2026
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
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lipocine Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06979544
- Sponsor's protocol ID
- LPCN 1154-24-002a
- Status last verified
- May 2025
- First submitted
- 13 May 2025
- Last updated
- 24 Feb 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 24 Feb 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 Saftey and Efficacy of Oral LPCN 1154A in Women With Postpartum Depression
- ClinicalTrials.gov ID
- NCT06979544
- Acronym / sponsor ID
- LPCN 1154-24-002a
- Conditions
- Depression, Postpartum, Depression, Post-Partum, Postpartum Depression (PPD), Post-Natal Depression, Peripartum Depression, Postnatal Depression
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Lipocine Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Jun 2025 (actual)
- Primary completion
- 16 Jan 2026 (actual)
- Study completion
- 17 Feb 2026 (actual)
- First posted
- 20 May 2025 (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
- If LPCN 1154A reduces anxiety symptoms in subjects with severe PPD
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 |
| 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 third trimester and later than the first 4 week following delivery
- Are < 12 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 within 1 year
- Have a history of seizure within 6 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 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.
7 secondary outcomes
Incidence, severity, and causality of AEs and SAEs
Time frame: upto Day 30
Change from baseline in HAM-D17 total score
Time frame: Baseline at Hours 12, and 36, Day 7 and Day 30
HAM-D17 response
Time frame: Baseline to Hours 12, and 36, 60, Day 7 and Day 30
HAM-D17 remission
Time frame: Hours 12, and 36, 60, Day 7 and Day 30
Patient Global Impression - Change (PGI-C) scale positive response
Time frame: Hours 12, and 36, 60, Day 7 and Day 30
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score
Time frame: Baseline to Hour 60 and Day 30
Change from baseline in Hamilton Anxiety Rating Scale (HAM-A) total score
Time frame: Baseline to Hours 12, 36, 60 Day 7 and 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 24 Feb 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 3 study testing LPCN 1154A in people with Depression, Postpartum and Depression, Post-Partum, run by Lipocine 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 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: finished, as of the sponsor's last update on 24 Feb 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 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?
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?
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 24 Feb 2026; AzTrials last refreshed its copy on 8 Nov 2026.