Phase 2
Completed N=202
A Study to Evaluate the Efficacy, Safety and Tolerability of Fixed Doses of Intranasal Esketamine in Japanese Participants With Treatment Resistant Depression
Source: ClinicalTrials.gov NCT02918318 ↗Enrolled (actual)
202
Serious AEs
1.8%
Results posted
Oct 2020
Primary outcomePrimary: Double-Blind (DB) Induction Phase: Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score up to Day 28 — -15.2; -14.5; -15.1; -15.3 Units on a scale — p=0.475
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Double-Blind (DB) Induction Phase: Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score up to Day 28 |
-15.2; -14.5; -15.1; -15.3 | 0.475 |
| SECONDARY DB Induction Phase: Percentage of Participants With Response Based on MADRS Total Score |
22.0; 13.2; 10.0; 9.0; 2.4; 2.6 | — |
| SECONDARY DB Induction Phase: Percentage of Participants With Remission Based on MADRS Total Score |
9.8; 0; 7.5; 3.8; 2.4; 0 | — |
| SECONDARY DB Induction Phase: Percentage of Participants Showing Onset of Clinical Response |
2.4; 2.6; 7.3; 6.3; 97.6; 97.4 | — |
| SECONDARY DB Induction Phase: Change From Baseline in Clinical Global Impression - Severity (CGI-S) Total Score up to Day 28 |
-1.0; -1.0; -1.0; -1.0 | — |
| SECONDARY DB Induction Phase: Change From Baseline in Generalized Anxiety Disorder 7-Item Scale (GAD-7) up to Day 28 |
-8.2; -7.8; -8.1; -7.7 | — |
| SECONDARY DB Induction Phase: Change From Baseline in Sheehan Disability Scale (SDS) Total Score up to Day 28 |
-8.6; -7.9; -9.5; -7.0 | — |
| SECONDARY Posttreatment Phase: Time to Relapse in Participants With Remission (MADRS Total Score <=12) |
34.0; 52.0; 37.0; 30.0 | — |
| SECONDARY Posttreatment Phase: Time to Relapse in Participants With Response (>=50% Reduction From Baseline in MADRS Total Score) But Who Are Not in Remission |
32.0; 26.0; 79.5; 91.0 | — |
| SECONDARY Posttreatment Phase: Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Weeks 2, 4, 6, 8, 12, 16, 20 and 24 |
-14.6; -8.1; -13.1; -11.2; -12.9; -8.3 | — |
| SECONDARY OL Induction Phase: Percentage of Participants With Remission Based on MADRS Total Score |
14.6; 23.4; 31.9; 42.6 | — |
| SECONDARY OL Induction Phase: Change From Baseline (Prior to the First Dose of OL Induction Phase) in MADRS Total Score up to Endpoint OL Induction Phase (Last Post Baseline Assessment Value During the OL Induction Phase [OL: up to Day 28]) |
16.1; -14.5 | — |
| SECONDARY OL Induction Phase: Percentage of Participants With Severity of Psychopathology on the CGI-S Scale |
0; 14.6; 0; 16.7; 4.2; 43.8 | — |
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)
Data sourced from ClinicalTrials.gov (NCT02918318). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.