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.
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.
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;
Parallel
Esketamine-dexmedetomidine combination
DrugThe 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).
Placebo
DrugThe 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).
Prevalence of depressive symptoms 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.
Prevalence of depressive symptoms 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.
Treatment response rates 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.
Prevalence of major depressive episode 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.
Length of hospital stay after giving birth
Length of hospital stay after giving birth
Time to initiation of breastfeeding
Time to initiation of breastfeeding after giving birth
Pain intensity 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.
Incidence of persistent pain at 42 days postpartum
Persistent pain is defined as pain with an NRS pain score ≥1 that persisted since childbirth.
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