This open-label pilot trial (n=25) will assess the safety, tolerability, and clinical effects of intranasal ketamine (IN) treatment in patients with Ultra-Resistant Depression (URD) who have not responded to convulsive therapy.
Open-label, single-group proof-of-concept study testing intranasal ketamine in outpatients with ultra‑resistant major depressive disorder who did not respond to or could not tolerate an acute course of convulsive therapy.
Intervention consists of intranasal ketamine administered via MAD300 atomiser twice weekly for four weeks (up to 8 sessions) with weight-based titration; patients monitored for 2 hours post-dose with vitals every 30 minutes; labetalol available for transient hypertension.
Outcomes include safety/tolerability, depressive symptom change (HRSD-24), suicidal ideation and quality of life measures, and neurophysiological biomarkers using TMS-EMG and EEG to assess cortical excitation and inhibition.
Open-label intranasal ketamine administered twice weekly for four weeks with weight-based titration using MAD300 atomiser; 2‑hour monitoring per session.
Intranasal administration via MAD300 atomiser; weight-based starting dose with titration; monitoring for 2 hours post-dose with vitals every 30 min; labetalol available for transient hypertension.