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New pill shows promise for severe postpartum depression in phase 3 trial

NCT ID NCT06979544

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested an oral drug called LPCN 1154A in 90 women with severe postpartum depression. The goal was to see if it reduces depressive and anxiety symptoms better than a placebo. Participants took the drug or a placebo and were monitored for side effects and mood changes using a standard depression scale.

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

90 people

The number who actually took part.

Started

Jun 2025

Finished

Feb 2026

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 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: * 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

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Conditions

The condition(s) this trial relates to.

postpartum depression

As listed by the trial registrant

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

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

Contacts and locations

Locations

  • Advanced Research Center

    Anahiem, California, 92805, United States

  • Alliance Research Institute

    Canoga Park, California, 91304, United States

  • Atlanta Behavioral Research

    Atlanta, Georgia, 30338, United States

  • Best Clinical Trials

    New Orleans, Louisiana, 70115, United States

  • CenExel Research Center

    Decatur, Georgia, 30030, United States

  • CenExel Research Center

    Savannah, Georgia, 31405, United States

  • Clinical Research Prime

    Idaho Falls, Idaho, 83404, United States

  • Cypress Medical Research Center, LLC

    Kansas City, Kansas, 67226, United States

  • D&H National Research Centers

    Miami, Florida, 33155, United States

  • Gadolin Research

    Beaumont, Texas, 77702, United States

  • Maximos OB/GYN

    League City, Texas, 77573, United States

  • MedOne Clinical Research, LLC

    Miami, Florida, 33145, United States

  • Meridian International Research

    Miami Gardens, Florida, 33014, United States

  • Monroe Biomedical Research

    Monroe, North Carolina, 28112, United States

  • New Dawn Wellness and Medical Center

    Houston, Texas, 77082, United States

  • Oasis Clinical Research

    Las Vegas, Nevada, 89121, United States

  • Populace Research

    Provo, Utah, 84604, United States

  • Suburban Research Associates

    Media, Pennsylvania, 19063, United States

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