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Intranasal esketamine · 2 trials · 2 indications
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.
The QT interval corrected for heart rate (QTc interval) using Fridericia, Bazett and study-specific power correction methods, will be measured by electrocardiograms (ECG).
| 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. |
| Sequence 1 | EXPERIMENTAL | Participants will receive Treatment A (intravenous placebo, Intranasal placebo and Oral placebo tablet matched to the moxifloxacin tablet) on Day 1 of period 1, Treatment B (intravenous placebo, 84 milligram (mg) of intranasal esketamine and Oral placebo tablet matched to the moxifloxacin tablet) on Day 1 of period 2, Treatment C (intravenous placebo, Intranasal placebo and 400 mg oral moxifloxacin tablet) on Day 1 of period 3, Treatment D (0.8 milligram per kilogram of intravenous esketamine, Intranasal placebo and Oral placebo tablet matched to the moxifloxacin tablet ) on Day 1 of period 4. Periods 1, 2, 3 and 4 will be separated by 5 to 7 days. |
| Sequence 2 | EXPERIMENTAL | Participants will receive Treatment A on Day 1 of period 1, Treatment C on Day 1 of period 2, Treatment B on Day 1 of period 3, Treatment D on Day 1 of period 4. Periods 1, 2, 3 and 4 will be separated by 5 to 7 days. |
| Sequence 3 | EXPERIMENTAL | Participants will receive Treatment B on Day 1 of period 1, Treatment C on Day 1 of period 2, Treatment A on Day 1 of period 3, Treatment D on Day 1 of period 4. Periods 1, 2, 3 and 4 will be separated by 5 to 7 days. |
| Sequence 4 | EXPERIMENTAL | Participants will receive Treatment B on Day 1 of period 1, Treatment A on Day 1 of period 2, Treatment C on Day 1 of period 3, Treatment D on Day 1 of period 4. Periods 1, 2, 3 and 4 will be separated by 5 to 7 days. |
| Sequence 5 | EXPERIMENTAL | Participants will receive Treatment C on Day 1 of period 1, Treatment A on Day 1 of period 2, Treatment B on Day 1 of period 3, Treatment D on Day 1 of period 4. Periods 1, 2, 3 and 4 will be separated by 5 to 7 days. |
| Sequence 6 | EXPERIMENTAL | Participants will receive Treatment C on Day 1 of period 1, Treatment B on Day 1 of period 2, Treatment A on Day 1 of period 3, Treatment D on Day 1 of period 4. Periods 1, 2, 3 and 4 will be separated by 5 to 7 days. |
| 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. |
| Intranasal Esketamine | DRUG | Participants will receive 84 mg intranasal esketamine as 3 devices, each with 28 mg esketamine. |
| Intravenous Esketamine | DRUG | Participants will receive 0.8 milligram per kilogram body weight esketamine, 40 minutes, intravenous infusion. |
| Moxifloxacin | DRUG | Participants will receive 400 mg Moxifloxacin orally. |
| Oral Placebo | DRUG | Participants will receive matching placebo orally. |
| Intravenous Placebo | DRUG | Participants will receive placebo 40 minutes, intravenous infusion. |
| Intranasal Placebo | DRUG | Participants will receive intranasal placebo (1 spray in each nostril at 0, 5, 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 an investigational small molecule being studied for use in depression, including treatment resistant depression, and in healthy participants for research purposes. It is developed by Johnson & Johnson (JNJ). The drug is still in clinical development and is not yet approved.
Intranasal Esketamine is developed by Johnson & Johnson, which trades under the ticker JNJ. The company is conducting clinical trials to evaluate the drug's safety and efficacy in depression and healthy participants.
Intranasal Esketamine is in Phase 1 and Phase 2 clinical development. One Phase 1 trial in healthy participants is completed, and one Phase 2 trial in Japanese participants with treatment resistant depression is also completed. The drug remains investigational.
Intranasal Esketamine has two completed trials: NCT02737605, a Phase 1 study evaluating effects on cardiac repolarization in healthy participants in Germany, and NCT02918318, a Phase 2 study of fixed doses in Japanese participants with treatment resistant depression. Both trials are completed.
Intranasal Esketamine is a form of esketamine administered via the intranasal route. The clinical trials listed for this drug specifically evaluate intranasal esketamine in depression and healthy participants. No other alternative names are provided.