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Not yet recruitingPhase 4

Intranasal Esketamine-dexmedetomidine Combination and Postpartum Depression

Key facts

Who runs it
Peking University First Hospital
Where
China1 site in 1 countryChoose a country to see its sites
Trial code
Status
Not yet recruiting
Phase
Phase 4
People taking part
164 people, planned
Started
Jun 2026
Expected to end
Dec 2029
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Esketamine-dexmedetomidine combination
  • Placebo
Record updated
15 June 2026

Who can take part

Age
18 years and older
Sex
Women only
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 8 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Refusal to participate in this study or concurrent participation in another clinical trial
  • 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)

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

Esketamine has rapid-onset antidepressant effects and may reduce postpartum depression in parturients with prenatal depressive symptoms. However, its adverse neuropsychiatric symptoms limits clinical application. Dexmedetomidine can alleviate these adverse symptoms and has independent antidepressant effect. This randomized, double-blind, placebo-controlled trial is designed to evaluate whether intranasal esketamine combined with dexmedetomidine can reduce the prevalence of postpartum depression in women with prenatal depressive symptoms.

The 2 groups in the trial

  • Intranasal esketamine-dexmedetomidineTreatment being tested

    Participants in this arm will receive intranasal administration of dexmedetomidine-esketamine combination. The dosage will be calculated based on body weight (approximately 0.4 μg/kg of dexmedetomidine and 0.2 mg/kg of esketamine). The mixture of study drugs will be administered via a nasal spray device, alternating between the two nostrils every 5 minutes, until the target dose is reached. The combination will be administered twice after chilbirth with an interval of 12 hours (2 sessions in total).

    Treatment: Esketamine-dexmedetomidine combination

  • Intranasal placeboPlacebo, for comparison

    Participants in this arm will receive intranasal administration of placebo (normal sline). The dosage (volume) will be calculated based on body weight in the same way as that in the intervention group. The placebo (normal saline) will be administered via a nasal spray device, alternating between the two nostrils every 5 minutes, until the target dose is reached. The placebo will be administered twice after childbirth with an interval of 12 hours (2 sessions in total).

    Treatment: Placebo

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Impact of Intranasal Esketamine-dexmedetomidine Combination on Postpartum Depression in Parturients With Prenatal Depressive Symptoms: a Randomized, Double-blind, and Placebo-controlled Trial
Record updated
15 June 2026