Clinical TrialMajor Depressive Disorder (MDD)EsketaminePlaceboCompleted

Esketamine vs Midazolam for MDD with Fluctuating Antidepressant Response: A Double-Blind Pilot RCT (Xiao 2023, Beijing Anding Hospital)

This unregistered trial (n=30) was a double-blind, midazolam-controlled pilot randomised clinical trial of intravenous esketamine for major depressive disorder with fluctuating antidepressant response in adults, which found significantly higher response rates in the esketamine group.

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Target Enrollment
30 participants
Study Type
interventional
Design
Randomized, double Blind

Detailed Description

This synthetic trial has been added to our database because a psychedelic paper (about a clinical trial) references this trial, but no (live) registration can be found.

The study was a single-centre, double-blind, pilot randomised clinical trial conducted at Beijing Anding Hospital. It investigated whether a single subanesthetic intravenous dose of esketamine (0.2 mg/kg) could boost the efficacy of ongoing oral antidepressant treatment in patients experiencing fluctuating symptoms of major depressive disorder.

Participants were randomised 1:1 to receive either esketamine or midazolam (0.045 mg/kg) as a control. The primary outcome was the MADRS response rate at two weeks. Results indicated that the esketamine group achieved significantly higher response rates compared to the midazolam group, with no serious adverse events or psychotogenic effects reported.

Study Arms & Interventions

Esketamine-treated group

experimental

Participants received a single subanesthetic intravenous dose of esketamine while maintaining their original oral antidepressant regimen.

Interventions

  • Esketamine0.2 mg/kg
    via IV• single dose• 1 doses total

    Administered over 40 minutes via syringe pump; participants maintained ongoing adequate antidepressant treatment (ADT).

Midazolam-controlled group

active comparator

Participants received a single intravenous dose of midazolam while maintaining their original oral antidepressant regimen.

Interventions

  • Placebo0.045 mg/kg
    via IV• single dose• 1 doses total

    Administered over 40 minutes via syringe pump; participants maintained ongoing adequate antidepressant treatment (ADT).

Study Details

Locations

China

Related Publications

Open AccessindividualPrimary

Esketamine vs Midazolam in Boosting the Efficacy of Oral Antidepressants for Major Depressive Disorder

In this single-centre pilot randomised, double-blind trial of 30 adults with major depressive disorder and fluctuating antidepressant response, a single subanaesthetic intravenous dose of esketamine (0.2 mg/kg) added to ongoing oral antidepressants produced markedly higher 2-week response rates (66.7% vs 6.7%) and greater reductions in MADRS scores than midazolam. No serious adverse events, psychotomimetic effects, or clinically significant manic symptoms were observed.

Published
Journal
JAMA Network Open
Authors
Xiao, C., Zhou, J., Zhu, X., Liu, J., Deng, Q., Wang, G., Wang, H., Hu, Y., Li, A.