Clinical TrialEsketaminePlaceboCompleted

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

Single-centre, double-blind, midazolam-controlled randomised clinical trial (JAMA Netw Open 2023; Xiao C, Zhou J, Li A, Zhang L; Beijing Anding Hospital, Capital Medical University, China; PMID 37578792). Participants: 30 adults with MDD and fluctuating antidepressant response (FAR), randomised 1:1. Intervention: single IV esketamine 0.2 mg/kg vs IV midazolam 0.045 mg/kg over 40 minutes, both in 50 mL normal saline; participants maintained on current oral antidepressant. Recruitment: August 2021–January 2022. Primary outcome: MADRS response (≥50% reduction) at 2 weeks. Secondary: MADRS remission, CGI-S, safety (CADSS, YMRS, C-SSRS). No formal sample size calculation; pilot study. CT.gov: 0 hits; PubMed DataBankList empty. Chinese RCTs post-2018 are typically ChiCTR-registered but number not recovered from available data.

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

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).

Primary Results(1 publication)

Participants

N = 30C. et al. 2023 →

Response Rates

≥50% reduction in Montgomery-Åsberg Depression Rating Scale (MADRS)

10/15(66.7%)·C. et al. 2023 →
1/15(6.7%)·C. et al. 2023 →
10/15(66.7%)·C. et al. 2023 →
5/15(33.3%)·C. et al. 2023 →

MADRS score of 10 or lower (remission)

10/15(66.7%)·C. et al. 2023 →
3/15(20.0%)·C. et al. 2023 →
8/15(53.3%)·C. et al. 2023 →
1/15(6.7%)·C. et al. 2023 →
8/15(53.3%)·C. et al. 2023 →
3/15(20.0%)·C. et al. 2023 →
9/15(60.0%)·C. et al. 2023 →
4/15(26.7%)·C. et al. 2023 →
7/15(46.7%)·C. et al. 2023 →
3/15(20.0%)·C. et al. 2023 →
6/15(40.0%)·C. et al. 2023 →
2/15(13.3%)·C. et al. 2023 →
9/15(60.0%)·C. et al. 2023 →
4/15(26.7%)·C. et al. 2023 →

Adverse Events (from all publications)

Arm / GroupnAny TEAESevereSeriousDiscont.
Esketamine-treated groupexperimental15——0(0.0%)1(6.7%)
Midazolam-controlled groupactive_comparator15——0(0.0%)0(0.0%)

* 1 participant discontinued due to withdrawal of consent (job change). No serious adverse events were observed.

* No serious adverse events were observed.

Study Details

  • Status
    Completed
  • Type
    interventional
  • Design
    Randomizeddouble Blind
  • Target Enrollment30 participants
  • Timeline
    Start: 2021-08-01
    End: 2022-01-31
  • Compounds
    EsketaminePlacebo

Related Publications

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

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

Your Library

Esketamine vs Midazolam for MDD with Fluctuating... — Clinical Trial Details | Blossom