Clinical TrialEsketamineCompleted

Oral Esketamine for Severe TRD: Multicenter Compassionate Use Open-Label Study (Veraart 2025, Netherlands)

Multicenter open-label study under compassionate use protocol (J Psychopharmacol 2025; Veraart JK, Smith-Apeldoorn SY, van der Meij A, Spijker J; Netherlands; PMID 40285334). Exempt from Dutch Medical Research Involving Human Subjects Act (MRIHA); no formal trial registration. Participants: n=185 patients with severe treatment-resistant depression; treatment resistance quantified by the Dutch Measure for Quantification of Treatment Resistance in Depression (DM-TRD). Intervention: 12 doses of oral esketamine in liquid formulation over 6 weeks (twice weekly) under off-label compassionate use; patients continued regular antidepressants and other psychiatric medications; benzodiazepines tapered to ≤2 mg/day prior to treatment. Primary outcomes: HDRS-17 and IDS-SR; functional outcomes assessed with WHODAS II; adverse events monitored with SAFTEE and Interstitial Cystitis Symptom Index. CT.gov: 0 hits; PubMed DataBankList: empty.

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Target Enrollment
185 participants
Study Type
interventional
Design
Non-randomized

Study Arms & Interventions

Oral esketamine

experimental

Individually titrated oral esketamine treatment twice-weekly for 6 weeks.

Interventions

  • Esketamine0.5 mg/kg
    via Oral• twice weekly• 12 doses total

    Doses were individually titrated from 0.5 or 1 mg/kg up to a maximum of 2.0 mg/kg (June 2017–April 2019) or 3.0 mg/kg (May 2019–June 2023).

Study Details

  • Status
    Completed
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment185 participants
  • Timeline
    Start: 2021-01-01
    End: 2024-01-01
  • Compound
    Esketamine

Related Publications

Open AccessindividualPrimary

Oral esketamine for patients with severe treatment-resistant depression: Effectiveness, safety, and tolerability of a six-week open-label treatment program

In a naturalistic open‑label study of 185 adults with severe treatment‑resistant depression, twice‑weekly individually titrated oral esketamine for six weeks significantly reduced depressive symptoms (HDRS‑17 mean 21.2→15.8, p<0.001) with MCID 47.1%, response 26.8% and remission 15.6%, and a low dropout rate (7.6%). Treatment was generally well tolerated with frequent but manageable side effects and no significant urinary or cognitive adverse effects, suggesting oral esketamine is a safe, patient‑friendly option with effectiveness comparable to other administration routes.

Published
Journal
Journal of Psychopharmacology
Authors
Veraart, J. K. E., Smith-Apeldoorn, S. Y., van der Meij, A., Spijker, J., Schoevers, R. A., Kamphuis, J.