A Study to Evaluate the Efficacy, Safety and Tolerability of Fixed Doses of Intranasal Esketamine in Japanese Participants With Treatment Resistant Depression

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 2

Conditions: Depression

Treatments: Drug: Intranasal esketamine (56 mg); Drug: Intranasal esketamine (28 mg); Drug: Intranasal esketamine (84 mg); Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02918318

CR108227

54135419TRD2005 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy of fixed dosed intranasal esketamine compared to intranasal placebo, as an add-on to an oral antidepressant in Japanese participants with treatment-resistant depression (TRD), in improving depressive symptoms.

Enrollment: 202 patients

Sex: All

Ages: 20 to 64 years old

Volunteers: No Healthy Volunteers

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 upon clinical assessment and confirmed by the Mini International Neuropsychiatric Interview (MINI). In the case of single-episode MDD, the participant must be diagnosed with persistent depressive disorder, which meets criteria of major depressive episode for a continuous duration of greater than or equal to (>=)2 years, and the same physician from the site must be examining the participant for >=2 years continuously as a primary care physician of the participant
• The participant's current major depressive episode, depression symptom severity (MADRS total score greater than or equal to [>=] 28 required), and antidepressant treatment response in the current depressive episode, must be confirmed using the SAFER interview
• Participant must be medically stable on the basis of clinical laboratory tests, physical examination, medical history, vital signs (including blood pressure), pulse oximetry, and 12-lead electrocardiogram (ECG) performed in the screening phase
• A woman of childbearing potential must have a negative highly sensitive serum Beta (β) human chorionic gonadotropin [β-hCG] test at the start of the screening phase and a negative urine pregnancy test must be obtained before the first dose of study drug on Day 1 of the double-blind induction phase prior to randomization
• Contraceptive use by men or women should be consistent with local regulations regarding the use of contraceptive methods for participant participating in clinical studies

Exclusion criteria

• Participant has received vagal nerve stimulation or has received deep brain stimulation in the current episode of depression
• Participant previously received esketamine or ketamine as treatment for their MDD
• Participant has homicidal ideation/intent, per the investigator's clinical judgment, or has suicidal ideation with some intent to act within 6 months prior to the start of the screening phase
• Participant has a history of moderate or severe substance or alcohol use disorder according to DSM-5 criteria, except nicotine or caffeine, within 6 months before the start of the screening phase
• Participant has a current or past history of seizure disorder (uncomplicated childhood febrile seizures with no sequelae are not exclusionary)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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202 participants in 4 patient groups

Placebo

Experimental group

Description:

Participant will receive 1 spray of placebo to each nostril at 0 minute, 5 minutes and 10 minutes.

Treatment:

Drug: Placebo

Esketamine 28 milligram (mg)

Experimental group

Description:

Participant will receive 1 spray of Esketamine to each nostril at 0 minute and placebo at 5 minutes and 10 minutes.

Treatment:

Drug: Intranasal esketamine (28 mg)

Esketamine 56 mg

Experimental group

Description:

Participant will receive 1 spray of Esketamine to each nostril at 0 minute, 5 minutes and placebo at 10 minutes.

Treatment:

Drug: Intranasal esketamine (56 mg)

Esketamine 84 mg

Experimental group

Description:

Participant will receive 1 spray of Esketamine to each nostril at 0 minute, 5 minutes and 10 minutes.

Treatment:

Drug: Intranasal esketamine (84 mg)