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

NCT ID: NCT02918318

Last Updated: 2025-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 202 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-12
• Study Completion Date: 2019-12-13

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo

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

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

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

Esketamine 28 milligram (mg)

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

Group Type: EXPERIMENTAL

Intranasal esketamine (28 mg)

Intervention Type: DRUG

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

Esketamine 56 mg

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

Group Type: EXPERIMENTAL

Intranasal esketamine (56 mg)

Intervention Type: DRUG

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

Esketamine 84 mg

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

Group Type: EXPERIMENTAL

Intranasal esketamine (84 mg)

Intervention Type: DRUG

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

Interventions

Placebo

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

Intervention Type: DRUG

Intranasal esketamine (28 mg)

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

Intervention Type: DRUG

Intranasal esketamine (56 mg)

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

Intervention Type: DRUG

Intranasal esketamine (84 mg)

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

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Pharmaceutical K.K.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Pharmaceutical K.K., Japan Clinical Trial

Role: STUDY_DIRECTOR

Janssen Pharmaceutical K.K.

Locations

Akita, , Japan

Fukui-shi, , Japan

Fukuoka, , Japan

Gunma, , Japan

Hachinohe-shi, , Japan

Hachioji-shi, , Japan

Hirakata, , Japan

Hiratsuka-shi, , Japan

Hokkaido, , Japan

Ibaraki, , Japan

Ichikawa, , Japan

Kanzaki-gun, , Japan

Karatsu, , Japan

Kashihara, , Japan

Kawasaki, , Japan

Kita-Azumi, , Japan

Kita-ku, , Japan

Kitakyushu, , Japan

Kobe, , Japan

Kochi, , Japan

Kodaira, , Japan

Komoro-shi, , Japan

Kumamoto, , Japan

Kure, , Japan

Kurume-shi, , Japan

Kyoto, , Japan

Maizuru, , Japan

Morioka, , Japan

Nagakute, , Japan

Nagasaki, , Japan

Okayama, , Japan

Okinawa, , Japan

Osaka, , Japan

Sapporo, , Japan

Setagaya-ku, , Japan

Shibuya-ku, , Japan

Shinjuku, , Japan

Shinjuku-ku, , Japan

Takatsuki-shi, , Japan

Toyoake, , Japan

Ube, , Japan

Yokohama, , Japan

Yonago, , Japan

Countries

Japan

References

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.

Reference Type: DERIVED

PMID: 35596932 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34696742 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217051&parentIdentifier=CR108227&attachmentIdentifier=4ef2af53-80a3-47f9-910f-3be69900934c&fileName=54135419TRD2005_(CR108227)_Additional_Results_Data_CH.pdf&versionIdentifier=

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

Other Identifiers

54135419TRD2005

Identifier Type: OTHER

Identifier Source: secondary_id

CR108227

Identifier Type: -

Identifier Source: org_study_id