Table 2.
Treatment comparison of efficacy and safety in induction phase (TRANSFORM‐3)
|
Esketamine + AD N = 72 Risk/100 Patients |
AD + placebo N = 65 Risk/100 Patients |
Treatment Difference (Esketamine + Oral AD) ‐ (Oral AD + Placebo) Risk Difference/100 Patients (95% CI) |
|
|---|---|---|---|
| Efficacy MADRS (Day 28) | |||
| Responder a (all) | 27 | 13.3 | 13.7 (−0.28 to 27.58) |
| Responder (65–74 years of age) | 28.3 | 13.2 | 15.1 (−0.08 to 30.27) |
| Remitters b (all) | 17.5 | 6.7 | 10.8 (−0.51 to 22.09) |
| Remitters (65–74 years of age) | 20.8 | 5.7 | 15.1 (2.53 to 27.66) |
| Safety | |||
| Death | 0 | 0 | 0 |
| Discontinuation due to common ADR c | 4.2 | 1.5 | 2.6 |
| Any serious or severe common ADR d | 4.2 | 3.1 | 1.1 (−5.15 to 7.33) |
| Dissociation | 0 | 0 | 0 |
| Dizziness | 0 | 1.5 | −1.5 |
| Nausea | 0 | 0 | 0 |
| Sedation | 0 | 0 | 0 |
| Headache | 0 | 0 | 0 |
| Vertigo | 0 | 0 | 0 |
| Dysgeusia | 1.4 | 0 | 1.4 |
| Hypoesthesia | 0 | 0 | 0 |
| Blood pressure increased | 1.4 | 0 | 1.4 |
| Anxiety | 1.4 | 1.5 | −0.1 |
| Vomiting | 0 | 0 | 0 |
| Any serious or severe common ADR | |||
| Day of dosing → day of dosing | 1.4 | 0 | 1.4 |
| Day of dosing → different day | 0 | 0 | 0 |
| Nondosing day | 2.8 | 3.1 | −0.3 (−5.96 to 5.36) |
| Postbaseline suicidal ideation |
N = 58 13.8 |
N = 54 16.7 |
−2.9 (−16.20 to 10.45) |
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.
Responder is defined as the proportion of patients achieving at least 50% improvement in MADRS at Day 28.
Remitter is defined as the proportion of patients achieving MADRS total score of ≤ 12 at Day 28. (All patients had baseline MADRS > 28).
Responder (without remission) is defined as the proportion of patients achieving at least 50% improvement in MADRS and MADRS total score > 12 at Day 28.
The following grouped terms with an incidence of ≥ 10% in TRD subjects treated with intranasal esketamine + 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.