Clinical TrialParallelPeripartumEsketaminePlaceboNot yet recruiting

Intranasal Esketamine-dexmedetomidine Combination and Postpartum Depression

This Phase IV, randomised, double-blind, placebo-controlled trial (n=164) will assess whether intranasal esketamine combined with dexmedetomidine can reduce postpartum depressive symptoms in women with prenatal depressive symptoms. The study will evaluate parturients aged 18 years and older who screen positive for prenatal depression, with the main outcome being the prevalence of depressive symptoms at 42 days postpartum. Participants will receive either an intranasal esketamine-dexmedetomidine combination or intranasal placebo (normal saline) in a parallel design. The active treatment will use body-weight-based dosing of approximately 0.4 μg/kg dexmedetomidine and 0.2 mg/kg esketamine, delivered by nasal spray alternating between nostrils every 5 minutes until the target dose is reached, and given twice after childbirth at a 12-hour interval. The placebo will follow the same administration schedule and weight-based volume calculation.

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Target Enrollment
164 participants
Study Type
Phase IV interventional
Design
Randomized, quadruple Blind

Detailed Description

Esketamine has rapid-onset antidepressant effects and may reduce the risk of 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.

Study Arms & Interventions

Intranasal esketamine-dexmedetomidine

experimental

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).

Interventions

  • Esketamine
    via Other• twice after childbirth with an interval of 12 hours• 2 doses total

Intranasal placebo

inactive

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).

Interventions

  • Placebo
    via Other• twice after childbirth with an interval of 12 hours• 2 doses total

Participants

Ages
18 – ?
Sexes
female

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.

Study Details

  • Status
    Not yet recruiting
  • Phase
    Phase IV
  • Type
    interventional
  • Design
    Randomizedquadruple Blind
  • Target Enrollment164 participants
  • Timeline
    Start: 2026-06-01
    End: 2029-12-01
  • Compounds
    EsketaminePlacebo
  • Topic
    Peripartum

Study Team

Sponsors & Collaborators

Locations

Peking University First Hospital — Beijing, Beijing Municipality, China