A Multi-Center, Open-Label, Single-Arm Study to Investigate the Early Effectiveness of Esketamine Nasal Spray in Patients with Treatment-Resistant Depression Using a Mobile Self-Monitoring Application.
Junhyung Kim, Seung-Hoon Lee, Cheolmin Shin, Kyu-Man Han, Sung Joon Cho, Narei Hong, Changsu Han
Pharmaceuticals (Basel, Switzerland) August 30, 2024 DOI: 10.3390/ph17091143 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Multi-center, open-label, single-arm study Peer reviewed |
|---|---|
| Population | Adults aged 18-65 years with treatment-resistant depression who had failed at least two antidepressant therapies, enrolled from five tertiary hospitals in South Korea |
| Intervention | Esketamine nasal spray |
| Duration | 4-week induction period with twice-weekly esketamine administration and daily mobile app use; assessments at baseline, week 2, and week 4 |
| Topics | Depression Esketamine |
| Keywords | Early effectiveness Mobile health Self-monitoring #depression-treatment antidepressants Mental health interventions #esketamine-therapy ketamine treatment Nasal spray medication Rapid-acting antidepressant #mhealth-monitoring |
| Citations | 8 |
| Key points | Esketamine nasal spray, complemented by mobile self-monitoring, effectively reduces depressive and anxiety symptoms early in the treatment course for treatment-resistant depression. |
Abstract
This study assesses the early effectiveness of esketamine nasal spray (ESK) in adults with treatment-resistant depression (TRD) 1 day after the first administration, as monitored through self-assessment via the mobile application, Esketamine Continuing Assessment for Relapse Prevention (EsCARe). In this multi-center, open-label, single-arm study, adults aged 18-65 years diagnosed with TRD after failing at least two antidepressant therapies were enrolled from five tertiary hospitals in South Korea. During the induction period, participants self-administered ESK twice weekly and used the EsCARe app daily to record mood, sleep, and somatic symptoms. Key clinical assessments, the Patient Health Questionnaire-9 (PHQ-9), the Hamilton Depression Rating Scale (HAMD), and the Generalized Anxiety Disorder Scale (GAD-7), were measured at baseline and at weeks 2 and 4. The reliability and validity of EsCARe was assessed. The treatment results indicated significant improvements in depressive and anxiety symptoms, with notable reductions in the PHQ-9 and the GAD-7 by week 2, and the HAMD by week 4. The EsCARe app reliably and validly monitored depressive symptoms and demonstrated a significant reduction in depressive symptoms 1 day after the first administration of ESK. Using ESK, complemented by mobile self-monitoring, effectively reduces the symptoms of TRD early in the treatment course. Integrating mobile health technology into the therapeutic regimen highlights a significant advancement in managing TRD, offering patients and clinicians immediate feedback on treatment efficacy.
Comparable studies
Other non-randomized and open-label trials on esketamine for depression, most cited first.