Clinical TrialEsketaminePlaceboCompleted

A Study to Evaluate the Efficacy and Safety of Esketamine Combined With Oral Antidepressants in the Treatment of Major Depressive Disorder With Suicidal Ideation

Phase 4 randomized parallel-group trial of esketamine (0.25 mg/kg) vs midazolam (0.02 mg/kg) as add-on to oral antidepressants in adolescent and adult patients with MDD and suicidal ideation. Four arms (adolescent/adult × esketamine/midazolam), 25 per arm, 100 total. Primary outcome: Columbia Suicide Severity Rating Scale. Sponsor: Affiliated Brain Hospital of Guangzhou Medical University, China.

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Target Enrollment
100 participants
Study Type
Phase IV interventional
Design
Randomized, double Blind

Study Arms & Interventions

Intravenous esketamine

experimental

3 infusions of esketamine (0.25 mg/kg) administered on days 1, 3, and 5, combined with routine inpatient care and oral antidepressants.

Interventions

  • Esketamine0.25 mg/kg
    via IV• 3 infusions over 5 days (days 1, 3, and 5)• 3 doses total

    Infused in 50 mL of 0.9% saline over 40 minutes.

Intravenous midazolam

active comparator

3 infusions of midazolam (0.045 mg/kg) administered on days 1, 3, and 5, combined with routine inpatient care and oral antidepressants.

Interventions

  • Placebo0.045 mg/kg
    via IV• 3 infusions over 5 days (days 1, 3, and 5)• 3 doses total

    Used as an active control/placebo; infused in 50 mL of 0.9% saline over 40 minutes.

Study Details

  • Status
    Completed
  • Phase
    Phase IV
  • Type
    interventional
  • Design
    Randomizeddouble Blind
  • Target Enrollment100 participants
  • Timeline
    Start: 2021-01-01
  • Compounds
    EsketaminePlacebo

Related Publications

Open AccessindividualPrimary

Short-term cognitive effects of repeated-dose esketamine in adolescents with major depressive disorder and suicidal ideation: a randomized controlled trial

In a randomised controlled trial of 51 adolescents with major depressive disorder and suicidal ideation, three subanaesthetic esketamine infusions (0.25 mg/kg) did not impair cognition and were associated with improved processing speed and some improvement in working memory by Day 12. Baseline cognitive performance did not predict antidepressant or antisuicidal response.

Published
Journal
Child and Adolescent Psychiatry
Authors
Lan, X-F., Wang, C-Y., Zhang, F., Liu, H., Mai, S., Ning, Y-P., Zhou, Y-L., Hu, Z., Li, W., Ye, Y.
PaywallindividualPrimary

Effect of Repeated Intravenous Esketamine on Adolescents With Major Depressive Disorder and Suicidal Ideation: A Randomized Active-Placebo-Controlled Trial

This placebo-controlled trial (n=54) investigates the efficacy and safety of esketamine (iv, 17.5mg, 3x) in adolescents suffering from depression (MDD) and suicidal ideation (SI). It shows significant reductions in Columbia Suicide Severity Rating Scale (C-SSRS) Ideation and Intensity scores and Montgomery-Åsberg Depression Rating Scale (MADRS) scores in the esketamine group compared to the midazolam (placebo) group at day six, with maintained antisuicidal and antidepressant responses at four weeks post-treatment.

Published
Journal
Child and Adolescent Psychiatry
Authors
Zhou, Y., Lan, X-F., Wang, C., Zhang, F., Liu, H., Chao, Z., Ning, Y-P., Fu, L., Hu, Z., Li, W., Ye, Y.