Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02918318 | A Study to Evaluate the Efficacy, Safety and Tolerability of Fixed Doses of Intranasal Esketamine in Japanese Participants With Treatment Resistant Depression | PHASE2 | COMPLETED | 202 | — | — | Dec 12, 2016 | Dec 13, 2019 | Apr 29, 2025 | 43 | Japan |
MADRS is clinician-rated scale designed to measure depression severity, and to detect changes due to antidepressant treatment. Scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of symptoms), summed for a total possible score of 0 to 60. Higher scores represent more severe condition. Negative change in score indicates improvement.
| Arm | Type | Description |
|---|---|---|
| Placebo | EXPERIMENTAL | Participant will receive 1 spray of placebo to each nostril at 0 minute, 5 minutes and 10 minutes. |
| Esketamine 28 milligram (mg) | EXPERIMENTAL | Participant will receive 1 spray of Esketamine to each nostril at 0 minute and placebo at 5 minutes and 10 minutes. |
| Esketamine 56 mg | EXPERIMENTAL | Participant will receive 1 spray of Esketamine to each nostril at 0 minute, 5 minutes and placebo at 10 minutes. |
| Esketamine 84 mg | EXPERIMENTAL | Participant will receive 1 spray of Esketamine to each nostril at 0 minute, 5 minutes and 10 minutes. |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Participant will receive 1 spray of placebo to each nostril at 0 minute, 5 minutes and 10 minutes. |
| Intranasal esketamine (28 mg) | DRUG | Participant will receive 1 spray of Esketamine to each nostril at 0 minute and placebo at 5 minutes and 10 minutes. |
| Intranasal esketamine (56 mg) | DRUG | Participant will receive 1 spray of Esketamine to each nostril at 0 minute, 5 minutes and placebo at 10 minutes. |
| Intranasal esketamine (84 mg) | DRUG | Participant will receive 1 spray of Esketamine to each nostril at 0 minute, 5 minutes and 10 minutes. |
Inclusion Criteria: * At the start of the screening phase, participant must meet the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnostic criteria for single-episode major depressive disorder (MDD) or recurrent major depressive disorder (MDD), without psychotic features, based u...