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Intranasal Esketamine · 1 trial · 1 indication
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...
Intranasal esketamine is a small molecule therapy developed by Johnson & Johnson (ticker JNJ) for depression. It is administered through the nose and has been studied in a Phase 2 clinical trial in Japanese participants with treatment resistant depression. It is an investigational treatment and is not approved for use.
Intranasal esketamine is being studied for the treatment of depression, specifically treatment resistant depression. The clinical development has focused on Japanese participants with this condition. It is an investigational therapy and has not been approved for any indication.
Intranasal esketamine is developed by Johnson & Johnson, which trades under the ticker symbol JNJ. The company is responsible for the clinical development of this investigational therapy for depression.
Intranasal esketamine is in Phase 2 clinical development. The completed trial was a Phase 2 study, and no active trials are currently listed. It remains an investigational therapy and is not approved for any indication.
Intranasal esketamine has been evaluated in a single completed Phase 2 trial, NCT02918318, titled "A Study to Evaluate the Efficacy, Safety and Tolerability of Fixed Doses of Intranasal Esketamine in Japanese Participants With Treatment Resistant Depression." The trial enrolled 202 participants in Japan and was randomized, double-blind, and controlled.