The Effect of a Four Week Intensified Pharmacological Treatment for Major Depressive Disorder Compared to Treatment as Usual in Subjects Who Had a First-time Treatment Failure on Their First-line Treatment. (INTENSIFY MDD)
Open-label, randomised, parallel trial with blinded raters (n=418) comparing early-intensified pharmacological treatment including esketamine or ketamine (twice-weekly for 4 weeks) plus a second-line antidepressant versus treatment as usual in adults (18–65) with MDD and first-line treatment failure.
Details
Rationale: MDD is common and treatment selection is often trial-and-error; early intensified treatment with (es)ketamine may prevent progression to treatment-resistant illness and reduce burden and costs.
Objective: To compare symptom severity change at six weeks (MADRS) between early-intensified pharmacological treatment (EIPT) and treatment as usual (TAU) in adults with MDD and first-line treatment failure.
Design: International, multicentre, randomised, open-label, parallel trial with blinded outcome assessors; participants randomised to EIPT (second-line antidepressant plus esketamine nasal spray or (es)ketamine/ketamine IV twice weekly for 4 weeks) or TAU (second-line antidepressant per physician).
Safety and monitoring: Standard safety measures (labs, ECG, vitals) and a 2-hour observation after each (es)ketamine/ketamine administration; adverse events recorded with standardized scales (GASE) and routine procedures.