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Single shot could lift postpartum depression, early trial hints

NCT ID NCT06342310

Symptom relief Sponsor: Reunion Neuroscience 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 a single injection of RE104 in 84 women with moderate-to-severe postpartum depression. The goal was to see if it reduces depressive symptoms better than a low-dose comparison. Results will help determine if this approach is safe and effective for new mothers.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

84 people

The number who actually took part.

Started

Jun 2024

Finished

Jun 2025

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

18 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.

Inclusion Criteria: * Is ≤15 months postpartum at Screening. * Meet DSM-5 criteria for postpartum depression (PPD): experiencing a major depressive episode that began at any time starting at the beginning of the second trimester (≥14 weeks) of pregnancy through 4 weeks post delivery. * Has a Hamilton Depression Scale (HAM-D) total score meeting severity threshold at Screening and Baseline. * Is not using any psychotropic medications or psychotherapy for 30 days prior to Screening, OR are on an already stable/established regimen of SSRIs or psychotherapy for 30 days prior to Screening. * Has ceased breastfeeding at Screening. * Has a negative pregnancy test at Screening and Day 0 prior to study drug administration. Exclusion Criteria: * History or active postpartum psychosis per Investigator assessment. * History of treatment-resistant depression within the current postpartum depressive episode. * Has a significant risk of suicide. * Active or medical history of bipolar disorder, schizophrenia, schizoaffective disorder, psychotic disorder and/or borderline personality disorder, or first-degree family history of psychosis or bipolar disorder. * Medically significant condition rendering unsuitability for the study . * Has received electroconvulsive therapy (ECT) or transcranial magnetic stimulation within 90 days prior to Screening. * Has used psychedelics such as psilocybin, ayahuasca, mescaline, or LSD (with the exception of cannabis) within 12 months prior to Screening. * Has used or will need to use prohibited medications.

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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.

Postpartum depression

Contacts and locations

Locations

  • Reunion Investigational Site

    Santa Monica, California, 90404, United States

  • Reunion Investigational Site

    Boulder, Colorado, 80045, United States

  • Reunion Investigational Site

    Denver, Colorado, 80209, United States

  • Reunion Investigational Site

    Lauderhill, Florida, 33319, United States

  • Reunion Investigational Site

    Tampa, Florida, 33613, United States

  • Reunion Investigational Site

    Birmingham, Alabama, 35209, United States

  • Reunion Investigational Site

    Tucson, Arizona, 85724, United States

  • Reunion Investigational Site

    Atlanta, Georgia, 30329, United States

  • Reunion Investigational Site

    Atlanta, Georgia, 30331, United States

  • Reunion Investigational Site

    Decatur, Georgia, 30030, United States

  • Reunion Investigational Site

    Marietta, Georgia, 30060, United States

  • Reunion Investigational Site

    Savannah, Georgia, 31405, United States

  • Reunion Investigational Site

    Honolulu, Hawaii, 96817, United States

  • Reunion Investigational Site

    Kansas City, Kansas, 66160, United States

  • Reunion Investigational Site

    Shreveport, Louisiana, 71106, United States

  • Reunion Investigational Site

    Baltimore, Maryland, 21205, United States

  • Reunion Investigational Site

    Rockville, Maryland, 20850, United States

  • Reunion Investigational Site

    Springfield, Massachusetts, 01103, United States

  • Reunion Investigational Site

    Novi, Michigan, 48377, United States

  • Reunion Investigational Site

    Albuquerque, New Mexico, 87131, United States

  • Reunion Investigational Site

    Buffalo, New York, 14202, United States

  • Reunion Investigational Site

    New York, New York, 10016, United States

  • Reunion Investigational Site

    New York, New York, 10026, United States

  • Reunion Investigational Site

    Chapel Hill, North Carolina, 27599, United States

  • Reunion Investigational Site

    Monroe, North Carolina, 28112, United States

  • Reunion Investigational Site

    Cleveland, Ohio, 44113, United States

  • Reunion Investigational Site

    Columbus, Ohio, 43210, United States

  • Reunion Investigational Site

    West Chester, Pennsylvania, 19380, United States

  • Reunion Investigational Site

    Austin, Texas, 78712, United States

  • Reunion Investigational Site

    Austin, Texas, 78737, United States

  • Reunion Investigational Site

    Austin, Texas, 78759, United States

  • Reunion Investigational Site

    Plano, Texas, 75093, United States

  • Reunion Investigational Site

    San Antonio, Texas, 78229, United States

  • Reunion Investigational Site

    Draper, Utah, 84020, United States

  • Reunion Investigational Site

    Salt Lake City, Utah, 84108, United States

  • Reunion Investigational Site

    Charlottesville, Virginia, 22903, United States

  • Reunion Investigational Site

    Seattle, Washington, 98105, United States

  • Reunion Investigational Site

    Madison, Wisconsin, 53719, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.