Poster
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(#12) Change in Clinician-Rated and Patient-Reported Depression Severity After Esketamine Nasal Spray as Monotherapy in Adult Patients With Treatment-Resistant Depression: A Post Hoc Analysis of Item Scores
Abstract: Objective: To evaluate improvements in items of the Montgomery-≈sberg Depression Rating Scale (MADRS) and Patient Health Questionnaire-9 (PHQ-9) over 4 weeks of esketamine nasal spray (ESK) monotherapy.
Methods: In this double-blind multicenter study (NCT04599855), patients were randomly assigned on day 1 to ESK 56 mg, ESK 84 mg, or placebo (PBO) twice weekly for 4 weeks. Mean change from baseline in MADRS and PHQ-9 items between treatment groups were evaluated using analysis of covariance models at day 2 (D2; MADRS), D15, and D28 (MADRS and PHQ-9). Treatment-emergent adverse events (TEAEs) were monitored throughout.
Results: The analysis included 378 patients (PBO, n=197; ESK 56 mg, n=86; ESK 84 mg, n=95), with baseline MADRS and PHQ-9 total scores of 37.3 and 20.0, respectively. All MADRS and PHQ-9 items improved from baseline to D28 with ESK. MADRS ratings of reported sadness and apparent sadness were significantly decreased in both ESK groups on D2 and D28; inner tension, reduced appetite, concentration difficulties, lassitude, and inability to feel were significantly decreased on D28 (all P
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