Clinical Effectiveness of Esketamine for Treatment-Resistant Depression: A Real-World Study of Patients in Mindful Health Solutions Clinics

Abstract: BACKGROUND: To generate real-world evidence of esketamine effectiveness for treatment resistant depression (TRD), this study assessed change in depressive symptoms after esketamine initiation in a large psychiatric practice based on Patient Health Questionnaire (PHQ-9) scores. METHODS: Adults with TRD initiating esketamine (first session=index date) were identified at Mindful Health Solutions clinics during 05/2018-01/2024. Baseline PHQ-9 score was the most recent score before or on the index date. Follow-up period spanned index date to end of patient clinical activity or data. Mean change in PHQ-9 scores from baseline and proportions of patients with severe depression were reported based on scores captured within 14 days after esketamine sessions. RESULTS: 911 patients were identified (mean age: 43.7 years, 56.6% female, 68.5% comorbid anxiety). Mean baseline PHQ-9 score was 16.3; 84.9% and 32.2% had baseline scores of ≥10 (moderate-to-severe depression) and ≥20 (severe depression), respectively. During the mean follow-up period of 12.8 months, patients had a mean of 24.9 esketamine sessions. After 8 sessions (induction), mean reduction in PHQ-9 score from baseline was 4.0 and 17.5% had severe depression, after 12 sessions, these statistics were 4.6 and 13.3%, and after 24 sessions they were 5.7 and 7.5%, respectively. Benefits were similar in patients with comorbid anxiety and larger in patients with baseline PHQ-9 scores indicating moderate-to-severe depression. CONCLUSIONS: Esketamine treatment was associated with clinically meaningful reduction in depressive symptoms (≥3 points) by induction completion. Improvement in depressive symptoms continued to increase by the 24th session. Findings support effectiveness of sustained esketamine treatment in TRD.Short Description: Data from clinics specializing in esketamine nasal spray administration was used to assess real-world effectiveness of this therapy for treatment resistant depression based on Patient Health Questionnaire scores. Clinically meaningful improvement of depressive symptoms from baseline (mean reduction ≥3 points) was evident after 8 esketamine treatment sessions (induction completion), and symptoms continued to improve after 24 sessions. Findings suggest clinical benefits of sustained esketamine treatment.Name of Sponsoring Organization(s): Johnson & Johnson Innovative Medicine