Not yet recruitingPhase 4

Intranasal Esketamine-dexmedetomidine Combination and Postpartum Depression

NCT07639099 · Peking University First Hospital

Closed to entry

Status

Not accepting participants

Phase 4

Phase

164

Target enrolment

Study sites

Outside the US

What it is testing

Summary

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

Prevalence of depressive symptoms at 42 days postpartum
Measured over At 42 days postpartum

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years

Ages

FEMALE

Sex

Not accepted

Healthy volunteers

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.

Where

1 study site

Facility	City	Region	Country
Peking University First Hospital	Beijing	Beijing Municipality	China

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

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NCT07639099 on ClinicalTrials.gov →

Last updated in the registry 2026-06-15. Registry records change; this page reflects the data build of 2026-08-25.

Where this trial sits

Substance

Ketamine

Indication

All 7 trials from Peking University First Hospital →