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 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.
Citations in the library
Cited by 7
- Systematic review and meta-analysis of intranasal esketamine for treatment-resistant depression: Evidence from real-world studies. Journal of Affective Disorders January 28, 2026
- Effects of ketamine on sleep and circadian rhythmicity in major depressive disorder and bipolar disorder: A systematic review. Journal of Affective Disorders May 6, 2026
- Digital Enablement of Psychedelic-Assisted Therapy in Non-Clinical Settings: A Systematic Review of Safety, Efficacy, and Implementation Models Psychoactives December 24, 2025
- Insomnia and Esketamine Add-On Therapy to Antidepressant Therapy in Patients with Treatment-Resistant Depression-A Pilot Study. Pharmaceuticals July 19, 2025
- Evaluating the abuse liability of ketamine in the treatment of mood disorders: A systematic review. Journal of Psychopharmacology June 24, 2026
and 2 more in the library
Cites 10
- Efficacy and Safety of Flexibly Dosed Esketamine Nasal Spray Combined With a Newly Initiated Oral Antidepressant in Treatment-Resistant Depression: A Randomized Double-Blind Active-Controlled Study American Journal of Psychiatry May 21, 2019
- Efficacy of Esketamine Nasal Spray Plus Oral Antidepressant Treatment for Relapse Prevention in Patients With Treatment-Resistant Depression JAMA Psychiatry June 5, 2019
- Efficacy and Safety of Intranasal Esketamine Adjunctive to Oral Antidepressant Therapy in Treatment-Resistant Depression JAMA Psychiatry December 27, 2017
- Efficacy and Safety of Intranasal Esketamine for the Rapid Reduction of Symptoms of Depression and Suicidality in Patients at Imminent Risk for Suicide: Results of a Double-Blind, Randomized, Placebo-Controlled Study American Journal of Psychiatry April 16, 2018
- Efficacy and Safety of Fixed-Dose Esketamine Nasal Spray Combined With a New Oral Antidepressant in Treatment-Resistant Depression: Results of a Randomized, Double-Blind, Active-Controlled Study (TRANSFORM-1) The International Journal of Neuropsychopharmacology July 9, 2019
and 5 more in the library