Skip to content
CompletedPhase 2Results posted

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

NCT02918318 · Janssen Pharmaceutical K.K.

Closed to entry
Status
Not accepting participants
Phase 2
Phase
202
Target enrolment
43
Study sites
Outside the US

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

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

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

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

20 Years to 64 Years
Ages
All
Sex
Not accepted
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)

Where

43 study sites

FacilityCityRegionCountry
AkitaJapan
Fukui-shiJapan
FukuokaJapan
GunmaJapan
Hachinohe-shiJapan
Hachioji-shiJapan
HirakataJapan
Hiratsuka-shiJapan
HokkaidoJapan
IbarakiJapan
IchikawaJapan
Kanzaki-gunJapan
KaratsuJapan
KashiharaJapan
KawasakiJapan
Kita-AzumiJapan
Kita-kuJapan
KitakyushuJapan
KobeJapan
KochiJapan
KodairaJapan
Komoro-shiJapan
KumamotoJapan
KureJapan
Kurume-shiJapan
KyotoJapan
MaizuruJapan
MoriokaJapan
NagakuteJapan
NagasakiJapan
OkayamaJapan
OkinawaJapan
OsakaJapan
SapporoJapan
Setagaya-kuJapan
Shibuya-kuJapan
ShinjukuJapan
Shinjuku-kuJapan
Takatsuki-shiJapan
ToyoakeJapan
UbeJapan
YokohamaJapan
YonagoJapan

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT02918318 on ClinicalTrials.gov →

Last updated in the registry 2025-04-29. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance

Indication