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Intranasal Esketamine-dexmedetomidine Combination and Postpartum Depression

2026年6月11日 更新者：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.

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

164

段階

  • フェーズ 4

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

  • 中国
    • Beijing Municipality
      • Beijing、Beijing Municipality、中国、100034
        • Peking University First Hospital
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：4倍

武器と介入

参加者グループ / アーム
介入・治療
実験的：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).
薬：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).
プラセボコンパレーター：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).
薬：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).
他の名前：
  • 生理食塩水

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Prevalence of depressive symptoms at 42 days postpartum
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Prevalence of depressive symptoms at 7 days postpartum
時間枠：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
時間枠：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
時間枠：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

その他の成果指標

結果測定
メジャーの説明
時間枠
Length of hospital stay after giving birth
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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.
時間枠：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.
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Peking University First Hospital

捜査官

  • 主任研究者：Dong-Xin Wang, MD, PhD、Peking University First Hospital

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年6月1日

一次修了 (推定)

2029年10月1日

研究の完了 (推定)

2029年12月1日

試験登録日

最初に提出

2026年6月4日

QC基準を満たした最初の提出物

2026年6月5日

最初の投稿 (実際)

2026年6月10日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月15日

QC基準を満たした最後の更新が送信されました

2026年6月11日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 2026-0287

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