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Intranasal Esketamine-dexmedetomidine Combination and Postpartum Depression

2026년 6월 11일 업데이트: Dong-Xin Wang, Peking University First Hospital

Impact of Intranasal Esketamine-dexmedetomidine Combination on Postpartum Depression in Parturients With Prenatal Depressive Symptoms: a Randomized, Double-blind, and Placebo-controlled Trial

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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

Perinatal depression is a common mental disorder in women during the perinatal period. Many studies have shown that existence of prenatal depressive symptoms is an important risk factor of postpartum depression. Early identification of pregnant women with symptoms of prenatal depression, and providing appropriate interventions may play important roles in reducing the incidence of postpartum depression.

Ketamine is an NMDA-receptor antagonist. Esketamine, the S-enantiomer of ketamine, has a higher affinity for the NMDA receptor and is approximately twice as potent as ketamine in anesthesia and analgesia. Recent studies have demonstrated that ketamine and esketamine have marked rapid-acting antidepressant effects, but often accompanied by neuropsychiatric adverse effects, including dizziness, hallucinations, nightmares, and dissociative symptoms. Intranasal esketamine is approved for treatment-resistant depression.

Dexmedetomidine, a highly selective α2-adrenergic receptor agonist, is commonly used as a perioperative adjuvant. Recently, its potential role in psychiatric disorders has drawn increasing attention, with evidence suggesting preventive and therapeutic effects on anxiety, depression, and post-traumatic stress disorder. Intranasal dexmedetomidine has been safely used in both adults and children, particularly for procedural sedation and preoperative administration.

Combined use of esketamine with dexmedetomidine has been shown to reduce the neuropsychiatric adverse effects associated with esketamine alone, while also exhibiting synergistic sedative and analgesic effects. The investigators suppose that, for pregnant women with prenatal depressive symptoms, intranasal administration of a low-dose esketamine-dexmedetomidine combination after childbirth may reduce the incidence of postpartum depression with fewer neuropsychiatric side effects.

This randomized controlled trial is designed to investigate the effect of esketamine-dexmedetomidine combination administered intranasally after childbirth on the incidence of postpartum depression among paturients with prenatal depressive symptoms.

연구 유형

중재적

등록 (추정된)

164

단계

  • 4단계

연락처 및 위치

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연구 연락처

연구 연락처 백업

연구 장소

  • 중국
    • Beijing Municipality
      • Beijing, Beijing Municipality, 중국, 100034
        • Peking University First Hospital
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

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  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Intranasal esketamine-dexmedetomidine

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).
의약품: Esketamine-dexmedetomidine 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 childbirth with an interval of 12 hours (2 sessions in total).
위약 비교기: Intranasal placebo

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).
의약품: Placebo
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).
다른 이름들:
  • 생리 식염수

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Prevalence of depressive symptoms at 42 days postpartum
기간: At 42 days postpartum
Maternal depression will be assessed using the 17-item Hamilton Depression Rating Scale (HAMD-17; scores range from 0 to 54, with higher scores indicating more severe depressive symptoms) at 42 days postpartum. A HAMD-17 total score ≥8 is defined as presence of at least mild depressive symptoms.
At 42 days postpartum

2차 결과 측정

결과 측정
측정값 설명
기간
Prevalence of depressive symptoms at 7 days postpartum
기간: At 7 days postpartum
Maternal depression will be assessed using the 17-item Hamilton Depression Rating Scale (HAMD-17; scores range from 0 to 54, with higher scores indicating more severe depressive symptoms) at 7 days postpartum at 7 days postpartum. A HAMD-17 total score ≥8 is defined as presence of at least mild depressive symptoms.
At 7 days postpartum
Treatment response rates at 7 and 42 days postpartum
기간: At 7 and 42 days postpartum
Treatment response is defined as a ≥50% reduction in the 17-item Hamilton Depression Rating Scale (HAMD-17; scores range from 0 to 54, with higher scores indicating more severe depressive symptoms) score from baseline.
At 7 and 42 days postpartum
Prevalence of major depressive episode at 42 days postpartum
기간: At 42 days postpartum
The presence of major depressive episodes will be diagnosed with the the Mini-International Neuropsychiatric Interview version 7.0.2 (MINI 7.0.2, depression module). The MINI 7.0.2 is a brief structured diagnostic interview to assess the diagnosis of depression.
At 42 days postpartum

기타 결과 측정

결과 측정
측정값 설명
기간
Length of hospital stay after giving birth
기간: Up to 30 days after giving birth
Length of hospital stay after giving birth
Up to 30 days after giving birth
Time to initiation of breastfeeding
기간: Up to 3 days after giving birth
Time to initiation of breastfeeding after giving birth
Up to 3 days after giving birth
Pain intensity at 1 and 7 days postpartum
기간: At 1 and 7 days postpartum
Pain intensity will be assessed using the Numeric Rating Scale (NRS; an 11-point scale where 0=no pain and 10=the worst pain), both at rest and with movement.
At 1 and 7 days postpartum
Incidence of persistent pain at 42 days postpartum
기간: At 42 days postpartum
Persistent pain is defined as pain with an NRS pain score ≥1 that persisted since childbirth.
At 42 days postpartum
Proportion of exclusive breastfeeding
기간: At 1, 7, and 42 days postpartum
Proportion of exclusive breastfeeding at 1, 7, and 42 days postpartum
At 1, 7, and 42 days postpartum
Maternal complications within 42 days.
기간: Up to 42 days postpartum
Maternal complications are defined as any medical conditions that required hospital visits and therapeutic intervention.
Up to 42 days postpartum
Neonatal complications within 42 days.
기간: Up to 42 days after birth
Neonatal complications are defined as any medical conditions that required hospital visits and therapeutic intervention.
Up to 42 days after birth

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Peking University First Hospital

수사관

  • 수석 연구원: Dong-Xin Wang, MD, PhD, Peking University First Hospital

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일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 6월 1일

기본 완료 (추정된)

2029년 10월 1일

연구 완료 (추정된)

2029년 12월 1일

연구 등록 날짜

최초 제출

2026년 6월 4일

QC 기준을 충족하는 최초 제출

2026년 6월 5일

처음 게시됨 (실제)

2026년 6월 10일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 15일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 11일

마지막으로 확인됨

2026년 6월 1일

추가 정보

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키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 2026-0287

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이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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