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

NCT02918318 | Completed Phase 2 Results

• 2 other identifiers: CR10822754135419TRD2005
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 43

Brief Summary

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.

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• Double-Blind (DB) Induction Phase: Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score up to Day 28

  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.

  Baseline (Day 1) up to Day 28 (DB phase) induction

Secondary Outcomes (12)

• DB Induction Phase: Percentage of Participants With Response Based on MADRS Total Score

  Days 2, 8, 15, 22 and 28 (DB induction phase)

• DB Induction Phase: Percentage of Participants With Remission Based on MADRS Total Score

  Days 2, 8, 15, 22 and 28 (DB induction phase)

• DB Induction Phase: Percentage of Participants Showing Onset of Clinical Response

  Day 2 up to Day 28 (DB induction phase)

• DB Induction Phase: Change From Baseline in Clinical Global Impression - Severity (CGI-S) Total Score up to Day 28

  Baseline (Day 1) up to Day 28 (DB induction pahse)

• DB Induction Phase: Change From Baseline in Generalized Anxiety Disorder 7-Item Scale (GAD-7) up to Day 28

  Baseline (Day 1) up to Day 28 (DB induction phase)

Study Arms (4)

Placebo

EXPERIMENTAL

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

Drug: Placebo

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.

Drug: Intranasal esketamine (28 mg)

Esketamine 56 mg

EXPERIMENTAL

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

Drug: Intranasal esketamine (56 mg)

Esketamine 84 mg

EXPERIMENTAL

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

Drug: Intranasal esketamine (84 mg)

Interventions

Placebo DRUG

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

Placebo

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.

Esketamine 28 milligram (mg)

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.

Esketamine 56 mg

Intranasal esketamine (84 mg) DRUG

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

Esketamine 84 mg

Eligibility Criteria

• Age: 20 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Pharmaceutical K.K.: lead

Study Sites (43)

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Akita, Japan

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Fukui-shi, Japan

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Fukuoka, Japan

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Gunma, Japan

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Hachinohe-shi, Japan

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Hachioji-shi, Japan

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Hirakata, Japan

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Hiratsuka-shi, Japan

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Hokkaido, Japan

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Ibaraki, Japan

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Ichikawa, Japan

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Kanzaki-gun, Japan

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Karatsu, Japan

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Kashihara, Japan

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Kawasaki, Japan

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Kita-Azumi, Japan

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Kita-ku, Japan

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Kitakyushu, Japan

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Kobe, Japan

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Kochi, Japan

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Kodaira, Japan

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Komoro-shi, Japan

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Kumamoto, Japan

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Kure, Japan

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Kurume-shi, Japan

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Kyoto, Japan

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Maizuru, Japan

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Morioka, Japan

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Nagakute, Japan

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Nagasaki, Japan

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Okayama, Japan

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Okinawa, Japan

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Osaka, Japan

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Sapporo, Japan

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Setagaya-ku, Japan

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Shibuya-ku, Japan

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Shinjuku, Japan

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Shinjuku-ku, Japan

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Takatsuki-shi, Japan

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Toyoake, Japan

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Ube, Japan

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Yokohama, Japan

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Yonago, Japan

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Related Publications (2)

• Ohnishi T, Wakamatsu A, Kobayashi H. Different symptomatic improvement pattern revealed by factor analysis between placebo response and response to Esketamine in treatment resistant depression. Psychiatry Clin Neurosci. 2022 Aug;76(8):377-383. doi: 10.1111/pcn.13379. Epub 2022 Jun 9.

  PMID: 35596932 DERIVED

• Takahashi N, Yamada A, Shiraishi A, Shimizu H, Goto R, Tominaga Y. Efficacy and safety of fixed doses of intranasal Esketamine as an add-on therapy to Oral antidepressants in Japanese patients with treatment-resistant depression: a phase 2b randomized clinical study. BMC Psychiatry. 2021 Oct 25;21(1):526. doi: 10.1186/s12888-021-03538-y.

  PMID: 34696742 DERIVED

Related Links

• A Randomized, Double-blind, Multicenter, Placebo-controlled Study to Evaluate the Efficacy, Safety and Tolerability of Fixed Doses of Intranasal Esketamine in Japanese Subjects With Treatment Resistant Depression

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Limitations and Caveats

Esk has transient dissociative effects that are difficult to blind, these specific events could have biased clinical staff who observed treatment sessions. To ensure an unbiased efficacy evaluation, remote, blinded MADRS raters were used.

Results Point of Contact

• Title: Global Medical Head
• Organization: Janssen Pharmaceutical K.K., Japan

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Pharmaceutical K.K., Japan Clinical Trial

  Janssen Pharmaceutical K.K.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2016
• First Posted: September 28, 2016
• Study Start: December 12, 2016
• Primary Completion: August 19, 2019
• Study Completion: December 13, 2019
• Last Updated: April 29, 2025
• Results First Posted: October 19, 2020

Record last verified: 2025-04

Locations

JP (43)