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Can a pill ease severe postpartum depression?

NCT ID NCT07822321

Symptom relief Sponsor: Lipocine Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 16, 2026 · Last updated Sep 17, 2026 · Updated 1 time

Summary

Researchers are testing an oral drug called LPCN 1154A as a possible treatment for severe postpartum depression. The trial enrolls women aged 15 to 45 who gave birth within the past 18 months and developed depression during pregnancy or shortly after delivery. Participants receive either the study drug or a placebo for 48 hours, and researchers measure changes in depression symptoms using a standard rating scale.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
an oral tablet form of brexanolone called LPCN 1154A
What this could lead to
If it works, women with severe postpartum depression could have an oral treatment option that does not require an IV infusion in a clinic.
What could go wrong
The trial is relatively small, and an oral form of this drug may not work as well as the intravenous version. Some participants receive a placebo, and side effects such as sedation or dizziness are possible.
Why investors are watching

Lipocine is a micro-cap company, so this Phase 3 readout carries outsized weight for its pipeline. The trial tests whether oral LPCN 1154A eases depressive symptoms in 120 women with severe postpartum depression and how well they tolerate it. A clear result would give the company its most advanced clinical data point in a serious condition.

If it works: A positive result could support a path toward regulatory filing and give Lipocine a late-stage asset in postpartum depression. That may open partnership or financing options for a company of its size.

If it fails: A failed or inconclusive result would leave the program without late-stage support and could set the company back. Phase 3 trials fail often, and a small company has fewer resources to absorb that outcome.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

15 to 45 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * 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: * 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

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Conditions

The condition(s) this trial relates to.

Depression postpartum depression

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Depression, postpartum Peripartum depression Post partum depression Post-natal depression Postnatal depression Postpartum depression (PPD)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    16 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Lipocine Investigational Site

    RECRUITING

    Tucson, Arizona, 85715, United States

  • Lipocine Investigational Site

    RECRUITING

    Canoga Park, California, 91304, United States

  • Lipocine Investigational Site

    RECRUITING

    Walnut Creek, California, 94596, United States

  • Lipocine Investigational Site

    RECRUITING

    Aurora, Colorado, 80045, United States

  • Lipocine Investigational Site

    RECRUITING

    Decatur, Georgia, 30030, United States

  • Lipocine Investigational Site

    RECRUITING

    Idaho Falls, Idaho, 83402, United States

  • Lipocine Investigational Site

    RECRUITING

    Chicago, Illinois, 60641, United States

  • Lipocine Investigational Site

    RECRUITING

    New Orleans, Louisiana, 70115, United States

  • Lipocine Investigational Site

    RECRUITING

    Las Vegas, Nevada, 89119, United States

  • Lipocine Investigational Site

    RECRUITING

    Princeton, New Jersey, 08540, United States

  • Lipocine Investigational Site

    RECRUITING

    Manhattan, New York, 10036, United States

  • Lipocine Investigational Site

    RECRUITING

    Chapel Hill, North Carolina, 27514, United States

  • Lipocine Investigational Site

    RECRUITING

    Plano, Texas, 75093, United States

  • Lipocine Investigational Site

    RECRUITING

    Richardson, Texas, 75080, United States

  • Lipocine Investigational Site

    RECRUITING

    Clinton, Utah, 84105, United States

  • Lipocine Investigational Site

    RECRUITING

    Orem, Utah, 84058, United States

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