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Could a nasal spray after childbirth ward off postpartum depression?

NCT ID NCT07639099

Disease control Sponsor: Peking University First Hospital 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a nasal spray containing esketamine and dexmedetomidine, given twice after childbirth, can lower the chance of postpartum depression in women who already had mild depressive symptoms during pregnancy. Esketamine is a fast-acting antidepressant, and dexmedetomidine may reduce its side effects while also helping mood. The trial will follow 164 women for 42 days after birth to see if the spray reduces depressive symptoms compared to a placebo.

What this could mean

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

Active substance
esketamine and dexmedetomidine nasal spray
What this could lead to
If it works, this could offer a fast-acting, non-invasive option to prevent postpartum depression in at-risk women.
What could go wrong
This is a Phase 4 trial with only 164 participants, so results may not apply to everyone. Esketamine can cause side effects like dizziness or hallucinations, and the combination's safety in new mothers is still being studied.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 164 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 years and older

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: * Pregnant women aged ≥18 years who are preparing for childbirth; * Positive prenatal depression screening, defined as a Patient Health Questionnaire-9 (PHQ-9) score ≥5. Exclusion Criteria: * History of schizophrenia or existence of communication barriers; * Severe obstetric complications, including severe preeclampsia, placenta accreta, HELLP syndrome, placenta previa, placental abruption, or ASA physical status classification \>III; * Contraindications to ketamine/esketamine, including refractory hypertension, severe cardiovascular disease (NYHA class ≥III), or hyperthyroidism; * Contraindications to dexmedetomidine, including severe bradycardia (heart rate \<50 bpm), or second-degree or higher atrioventricular block; * Unsuitable for intranasal administration due to nasal cavity diseases (e.g., rhinitis, nasal polyps, or nasal congestion of any cause); * Refusal to participate in this study or concurrent participation in another clinical trial.

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Conditions

The condition(s) this trial relates to.

Depression parturient paresis postpartum depression prevention target

As listed by the trial registrant

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

Depressive symptoms Dexmedetomidine Esketamine Intranasal administration Parturients Postpartum depression

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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 ↗

  3. 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

Locations

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034, China

More trials for these conditions

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