Table 1.
Treatment comparison of efficacy and safety in induction phase (pooled studies TRANSFORM‐1 and 2)
|
Esketamine + AD Risk/100 Patients N = 343 |
AD + placebo Risk/100 Patients N = 222 |
Treatment Difference (Esketamine‐Placebo) |
|
|---|---|---|---|
|
(Esketamine + AD) – (AD + placebo) Risk Difference/100 Patients (95% CI) | |||
| Efficacy MADRS (Day 28) | |||
| Responders | |||
| TRANSFORM‐1 (56 mg) | 54.1 | 38.9 | 15.2 (2.11–28.22) |
| TRANSFORM‐1 (84 mg) | 53.1 | 14.2 (0.68–27.67) | |
| TRANSFORM‐2 | 69.3 | 52 | 17.3 (4.01–30.60) |
| Remitters | |||
| TRANSFORM‐1 (56 mg) | 36 | 30.6 | 5.5 (−6.98 to 17.94) |
| TRANSFORM‐1 (84 mg) | 38.8 | 8.2 (−4.76 to 21.20) | |
| TRANSFORM‐2 | 52.5 | 31 | 21.5 (8.17–34.78) |
| Safety | |||
| Death | 0.3 | 0 | 0.3 |
| Discontinuation due to common ADR a | 2.6 | 0 | 2.6 |
| Any serious or severe common ADR a | 12 | 3.6 | 8.4 (4.13–12.57) |
| Dissociation | 4.4 | 0 | 4.4 |
| Dizziness | 2.6 | 0.5 | 2.2 |
| Nausea | 1.5 | 0 | 1.5 |
| Sedation | 0.9 | 0.5 | 0.4 |
| Headache | 1.5 | 0.9 | 0.6 (−1.22 to 2.33) |
| Vertigo | 2.9 | 0.5 | 2.5 |
| Dysgeusia | 1.7 | 0 | 1.7 |
| Hypoesthesia | 0.6 | 0 | 0.6 |
| Blood pressure increased | 0 | 0 | 0 |
| Anxiety | 1.7 | 1.8 | −0.1 (−2.29 to 2.18) |
| Vomiting | 1.5 | 0 | 1.5 |
| Any serious or severe common ADR | |||
| Day of dosing → day of dosing | 10.2 | 1.4 | 8.9 (5.31 to 12.40) |
| Day of dosing → different day | 1.2 | 0.5 | 0.7 |
| Nondosing day | 1.5 | 2.3 | −0.8 (−3.12 to 1.53) |
| Postbaseline suicidal ideation |
N = 254 10.2 |
N = 162 12.3 |
−2.1 (−8.40 to 4.18) |
TRANSFORM‐1: esketamine 56 mg + AD, N = 115; esketamine 84 mg + AD, n = 114; AD + placebo, n = 113.
TRANSFORM‐2: esketamine + AD, n = 114; AD + placebo, n = 109.
MADRS total score ranges from 0 to 60; a higher score indicates a more severe condition. Negative change in score indicates improvement.
AD, antidepressant; ADR, adverse drug reaction; CI, confidence interval; MADRS, Montgomery‐Åsberg Depression Rating Scale; TRD, treatment‐resistant depression.
The following grouped terms with an incidence of ≥ 10% in TRD subjects treated with esketamine nasal spray + oral AD and greater than oral AD + placebo are regarded as common ADRs: dissociation, dizziness, nausea, sedation, headache, vertigo, dysgeusia, hypoesthesia, blood pressure increased, anxiety, and vomiting. No CI provided if the number of events is 0 or 1 in either group.