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. 2023 Dec 13;15(12):2773. doi: 10.3390/pharmaceutics15122773

Table 2.

Characteristics of observational studies included in the systematic review.

Author, Year Study Design Population Study Main Outcomes Duration Study Drug Main Findings
Estrade et al., 2023
[43]
OS 105 MDD patients with TRD Define trajectories of ESK response using MADRS score 5 months IN ESK 28–84 mg After two ESK administrations, the MADRS score predicted the 90-day trajectories of response with an accuracy of 80%.
Singh et al., 2023
[44]
OS 62 MDD patients with TRD Change in QIDS-SR score and time to achieve response and remission Up to 6 weeks Ketamine IV 0.5 mg/kg vs. IN ESK 56–84 mg There was no significant difference in response and remission rates between IV and IN routes. A significantly faster time to remission was observed in the ketamine IV group compared to the IN ESK group (HR = 5.0, p = 0.02).
Brendle et al., 2022
[45]
OS 171 MDD patients Change in GAD-7 and PHQ-9 scores 1 to 71 treatment sessions IN ESK 56–84 mg Significant reduction in PHQ-9 and GAD-7 scores was observed between baseline and last available treatment (PHQ-9 = mean [SD]: 16.7 [5.82] vs. 12 [6.38], p < 0.001; GAD-7 = mean [SD]: 12.0 [5.8] vs. 8.7 [5.62], p < 0.001).
Martinotti et al., 2022
[46]
OS 116 MDD patients with TRD Change in MADRS score and response and remission rates 3 months ESK 28–84 mg Significant improvement in MADRS score was observed at months 1 (T1) and 3 (T2) (Student t-test baseline vs. T1: t −15.79, p < 0.0001; T2 vs. baseline: t 18.07, p < 0.0001).
Samalin et al., 2022,
[47]
OS 66 MDD patients with TRD Characteristics of TRD patients receiving IN ESK, change in MADRS score 30 days (median treatment exposure) ESK 28–84 mg A decrease in MADRS score by 36% was observed from baseline to week 4 (mean MADRS score: 30.9 vs. 19.5, respectively).

Abreviations: ESK: esketamine; GAD: general anxiety disorder; HR: hazard ratio; IN: intranasal, IV: intravenous; MADRS: Montgomery–Asberg Depression Rating Scale; MDD: major depressive disorder; OS: observational study; PHQ-9: patient health questionnaire; QIDS-SR: Quick Inventory of Depressive Symptomatology-Self Report; SD: standard deviation; TRD: treatment-resistant depression.