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.