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NCT07639099
Intranasal Esketamine-dexmedetomidine Combination and Postpartum Depression
Conditions: Parturients, Depressive Symptoms, Esketamine, Dexmedetomidine, Intranasal Administration, Postpartum Depression
Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 164
Sponsor: Peking University First Hospital
Location: Peking University First Hospital Beijing Beijing Municipality
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.
Eligibility Criteria
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 \
Source: ClinicalTrials.gov (NCT07639099). StuddyBuddy aggregates publicly available trial information.
