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Clinical application of a new technique of esketamine rapid antidepressant treatment in adolescents and maternal cesarean section population

Clinical application of a new technique of esketamine rapid antidepressant treatment in adolescents and maternal cesarean section population

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300071004
Enrollment
Unknown
Registered
2023-04-28
Start date
2023-05-01
Completion date
Unknown
Last updated
2023-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Interventions

Adolescent esketamine group:Esketamine was administered as a 0.25 mg/kg injection diluted to 50 ml intravenous drip over 40 minutes with saline injection. For all subjects in the esketamine and contro
if not at an effective dose then the dose was rapidly increased to an effective dose after enrollment. Patients not currently taking medication were started on sertraline hydrochloride at a dose of 50
Adolescent control group:For all subjects in the esketamine and control groups who were currently taking SSRI/SNRI antidepressants and were at an effective dose, the original treatment was maintained
if not at an effective dose, it was rapidly increased to an effective dose after enrollment. Patients not currently taking medication were started on sertraline hydrochloride at a dose of 50-200 mg
Maternal esketamine group:In the esketamine group, esketamine (0.25 mg/kg diluted in 10 mL of 0.9% saline) was administered 10 minutes after delivery of the fetus by cesarean section. A trained invest
pill dose: 2 ml, lock time: 8 min)
Maternal conventional anesthetic analgesia control group:No esketamine was given to the control group. A

Sponsors

Beijing Chaoyang Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
14 Years to No maximum

Inclusion criteria

Inclusion criteria: Adolescent inclusion criteria: 1, Diagnosis by a practicing psychiatrist using the Mental Neurology International Brief Interview Questionnaire (M.I.N.I.) meeting diagnostic criteria for depressive disorder without psychotic symptoms; 2. those with a total Montgomery-Asselberg Depression Rating Scale (MARDS) score = 22, including a score of = 1 for the suicide entry, but whose legal guardians and themselves do not accept the recommendation for referral to a psychiatric hospital and still request treatment at this study site; 3. aged 14-18 years, regardless of gender; 4, able to understand the content of the scale and cooperate with the assessment; 5. Legal guardians and themselves signed the study informed consent form and accepted the follow-up. Maternal enrollment criteria: (1) Having more than 1 risk factor for postpartum depression: such as previous history of depression or positive family history, marital problems, adverse life events, inadequate support, low socioeconomic status, advanced age and pregnancy comorbidities such as gestational diabetes mellitus; (2) Pregnant women eligible for American Society of Anesthesiologists (ASA) classification II for proposed cesarean section; (3) Age = 18 years; (4) Consent to postoperative analgesia; (5) able to understand the content of the scale and cooperate with the assessment (6) Legal guardians and themselves signed the study informed consent form and accepted the follow-up.

Exclusion criteria

Exclusion criteria: Adolescent exclusion criteria: 1. patients with previous or current organic mental disorders, neurodevelopmental disorders, neurocognitive disorders, substance-related and addictive disorders, psychotic disorders, bipolar disorders, obsessive-compulsive disorders; 2. patients whose current primary diagnosis is not a depressive disorder; 3, Patients who are currently at high risk of suicide: such as those with serious suicide attempts, who have recently attempted suicide; and those without family caregivers who cannot be accompanied by a designated guardian; 4, female patients during pregnancy or lactation; 5, ketamine, esketamine, or midazolam are contraindicated; 6, Patients who have used ECT or NMDA receptor antagonists within the last 6 months; 7. Patients with current uncontrolled respiratory disease, cardiovascular disease, neurological disease, or other serious physical disease that is difficult to control, such as: patients with severe cardiovascular disease and hyperthyroidism, patients with increased intracranial pressure cerebral hemorrhage, and patients with glaucoma. Maternal exclusion criteria: (1) Patients with current depressive disorders, organic psychiatric disorders, neurodevelopmental disorders, neurocognitive disorders, substance-related and addictive disorders, psychotic disorders, bipolar disorders, and obsessive-compulsive disorders; (2) Abnormal electrocardiograms, hypertension, and severe heart disease; (3) History of ketamine, esketamine abuse dependence, drug or alcohol dependence for more than 6 months; (4) Previous ketamine, esketamine treatment is ineffective or there are serious adverse reactions.

Design outcomes

Primary

MeasureTime frame
MADRS;

Secondary

MeasureTime frame
Stroop-color-worldtest;

Countries

china

Contacts

Public Contactyongdong hu

Beijing Chaoyang Hospital

huyongdong@bjcyh.com+86 18211085181

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026