Trial · NCT02918318
A Study to Evaluate the Efficacy, Safety and Tolerability of Fixed Doses of Intranasal Esketamine in Japanese Participants With Treatment Resistant Depression
NCT02918318, Phase 2, Completed, Janssen Pharmaceutical K.K.; results first posted 2020-10-19
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Study to Evaluate the Efficacy, Safety and Tolerability of Fixed Doses of Intranasal Esketamine in Japanese Participants With Treatment Resistant Depression. Trials, record NCT02918318. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02918318
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Efficacy, Safety and Tolerability of Fixed Doses of Intranasal Esketamine in Japanese Participants With Treatment Resistant Depression
- NCT number
- NCT02918318
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 202 participants, actual
- Lead sponsor
- Janssen Pharmaceutical K.K.
- Conditions
- Depression
- Interventions
- Placebo, Intranasal esketamine (28 mg), Intranasal esketamine (56 mg), Intranasal esketamine (84 mg)
- First posted
- 2016-09-28
- Last updated
- 2025-04-29
- Results first posted
- 2020-10-19
- 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.
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Double-Blind (DB) Induction Phase: Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score up to Day 28 | Baseline (Day 1) up to Day 28 (DB phase) induction | 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. |
| Secondary | DB Induction Phase: Percentage of Participants With Response Based on MADRS Total Score | Days 2, 8, 15, 22 and 28 (DB induction phase) | A participant is defined as responder (yes=1 and no=0) at a given time point if the percent improvement from baseline in MADRS is greater than or equal to (\>=) 50 percent (%). 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. |
| Secondary | DB Induction Phase: Percentage of Participants With Remission Based on MADRS Total Score | Days 2, 8, 15, 22 and 28 (DB induction phase) | A participant was considered in remission at a given time point if the MADRS total score \<=12. 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. |
| Secondary | DB Induction Phase: Percentage of Participants Showing Onset of Clinical Response | Day 2 up to Day 28 (DB induction phase) | A participant was defined as having a clinical response if there was at least 50% improvement from baseline in the MADRS total score with onset by Day 2 that was maintained to Day 28 in DB induction phase. Participants were allowed one excursion (non-response) on Days 8, 15 or 22, provided the score is at least 25% improvement. 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. |
| Secondary | 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) | CGI-S provides measure of severity of participant's illness including participant's history, psychosocial circumstances, symptoms, behavior and impact of symptoms on ability to function. CGI-S evaluates severity of psychopathology on scale of 0 to 7. Considering total clinical experience, participant is assessed on severity of mental illness according to: 0=not assessed; 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among most extremely ill patients. Values of 0 (not assessed) were excluded from analysis. CGI-S permits global evaluation of participant's condition at given time. |
| Secondary | 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) | GAD-7 was a brief and validated 7-item self-report assessment of overall anxiety. Participants respond to each item using a 4-point scale with response categories of 0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day. Item responses are summed to yield a total score with a range of 0 to 21, where higher scores indicate more anxiety. The recall period is 2 weeks. The severity of the GAD-7 is categorized as follows: None (0-4), Mild (5-9), Moderate (10-14) and Severe (15 -21). |
| Secondary | DB Induction Phase: Change From Baseline in Sheehan Disability Scale (SDS) Total Score up to Day 28 | Baseline (Day 1) to Day 28 (DB induction phase) | SDS is a participant-reported outcome measure and 5 item questionnaire used for assessment of functional impairment and associated disability. First three items assess disruption of 1 work/school, 2 social life, 3 family life/home responsibilities using a 0(no impairment)-10 (most severe impairment). Score for first 3 items are summed to create total score of 0-30 where higher score indicates greater impairment and a negative change in score indicates improvement. It also has one item on days lost from school or work and one item on days when under productive. |
| Secondary | Posttreatment Phase: Time to Relapse in Participants With Remission (MADRS Total Score <=12) | From EndPoint (last post baseline assessment value during the DB induction phase [up to Day 28]) up to 24 weeks (posttreatment phase) | Time to relapse in participants with remission at the end of the double-blind phase was defined as the time between induction phase and the first documentation of a relapse event during the posttreatment phase. Relapse was defined as any of the following: 1) MADRS total score \>= 22 for 2 consecutive assessments. The date of the second MADRS assessment was used for the date of relapse; 2) Hospitalization for worsening depression or any other clinically relevant event determined per clinical judgment to be suggestive of relapse of depressive illness like suicide attempt, completed suicide, or hospitalization for suicide prevention. If hospitalized for any of these events, start date of hospitalization was used as relapse date. If participant was not hospitalized, event date was used. 3) If both relapse criteria were met, earlier date was defined as date of relapse. Remission was defined as MADRS total score \<=12. |
| Secondary | Posttreatment Phase: Time to Relapse in Participants With Response (>=50% Reduction From Baseline in MADRS Total Score) But Who Are Not in Remission | From EndPoint (last post baseline assessment value during the DB induction phase [up to Day 28]) up to 24 weeks (posttreatment phase) | Time to relapse in participants with response (\>=50% reduction from baseline in MADRS total score) but who are not in remission was reported. Relapse is defined as any of the following: 1) MADRS total score \>= 22 for 2 consecutive assessments. The date of the second MADRS assessment was used for the date of relapse. 2)Hospitalization for worsening depression or any other clinically relevant event determined per clinical judgment to be suggestive of relapse of depressive illness like suicide attempt, completed suicide, or hospitalization for suicide prevention. If hospitalized for any of these events, start date of hospitalization was used as relapse date. If participant was not hospitalized, event date was used. 3) If both relapse criteria were met, earlier date was defined as date of relapse. Remission was defined as MADRS total score \<=12. |
| Secondary | Posttreatment Phase: Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Weeks 2, 4, 6, 8, 12, 16, 20 and 24 | Baseline (DB induction phase), Weeks 2, 4, 6, 8, 12, 16, 20 and 24 (posttreatment phase) | SDS is a participant-reported outcome measure and is a 5-item questionnaire which has been widely used and accepted for assessment of functional impairment and associated disability. The first three items assess disruption of (1) work/school, (2) social life, and (3) family life/home responsibilities using a 0-10 rating scale. The score for the first three items are summed to create a total score of 0-30, where a higher score indicates greater impairment. It also has one item on days lost from school or work and one item on days when under productive. FAS (responders): All randomized participants who received at least 1 dose of intranasal study medication during DB induction phase and who were responders at the end of DB induction phase and entered posttreatment phase |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Double-Blind (DB) Induction Phase: Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score up to Day 28 | Baseline (Day 1) up to Day 28 (DB phase) induction | Full analysis set (FAS \[DB\]) included all randomized participants who received at least 1 dose of intranasal study agent during the DB induction phase. Here, N (Number of participants analyzed) signifies those participants who were evaluable for this outcome measure (OM). | Units on a scale | MEAN |
| SECONDARY | DB Induction Phase: Percentage of Participants With Response Based on MADRS Total Score | Days 2, 8, 15, 22 and 28 (DB induction phase) | FAS (DB) included all randomized participants who received at least 1 dose of intranasal study agent during the DB induction phase. Here 'n' (number analyzed) signifies number of participants who were evaluable for this OM at specified timepoints. | Percentage of participants | NUMBER |
| SECONDARY | DB Induction Phase: Percentage of Participants With Remission Based on MADRS Total Score | Days 2, 8, 15, 22 and 28 (DB induction phase) | FAS (DB) included all randomized defined as all participants who received at least 1 dose of intranasal study agent during the DB induction phase. Here 'n' (number analyzed) signifies number of participants who were evaluable for this OM at specified timepoints. | Percentage of participants | NUMBER |
| SECONDARY | DB Induction Phase: Percentage of Participants Showing Onset of Clinical Response | Day 2 up to Day 28 (DB induction phase) | FAS (DB) included all randomized participants who received at least 1 dose of intranasal study agent during DB induction phase. Participants with missed assessments or discontinued early were not considered to have onset of clinical response. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this OM. | Percentage of participants | NUMBER |
| SECONDARY | 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) | FAS (DB) included all randomized participants who received at least 1 dose of intranasal study agent during the DB induction phase. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this OM. | Units on a scale | MEDIAN |
| SECONDARY | 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) | FAS included all randomized participants who received at least 1 dose of intranasal study agent during the DB induction phase. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this OM. | Units on a scale | MEAN |
| SECONDARY | DB Induction Phase: Change From Baseline in Sheehan Disability Scale (SDS) Total Score up to Day 28 | Baseline (Day 1) to Day 28 (DB induction phase) | FAS (DB) included all randomized participants who received at least 1 dose of intranasal study agent during the DB induction phase. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this OM. | Units on a scale | MEAN |
| SECONDARY | Posttreatment Phase: Time to Relapse in Participants With Remission (MADRS Total Score <=12) | From EndPoint (last post baseline assessment value during the DB induction phase [up to Day 28]) up to 24 weeks (posttreatment phase) | Population included participants with remit at the end of DB. | Days | MEDIAN |
| SECONDARY | Posttreatment Phase: Time to Relapse in Participants With Response (>=50% Reduction From Baseline in MADRS Total Score) But Who Are Not in Remission | From EndPoint (last post baseline assessment value during the DB induction phase [up to Day 28]) up to 24 weeks (posttreatment phase) | Population included participants with response (not remit) at the end of DB. | Days | MEDIAN |
| SECONDARY | Posttreatment Phase: Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Weeks 2, 4, 6, 8, 12, 16, 20 and 24 | Baseline (DB induction phase), Weeks 2, 4, 6, 8, 12, 16, 20 and 24 (posttreatment phase) | Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this OM. Here, 'n' (number analyzed) signifies number of participants who were evaluable for this OM at specified timepoints. | Units on a scale | MEAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group124
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Double-Blind (DB) Induction Phase: Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score up to Day 28 | Esketamine 28 Milligrams (mg) | -15.2 | Standard Deviation 13.07 | Units on a scale | |
| Double-Blind (DB) Induction Phase: Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score up to Day 28 | Esketamine 56 mg | -14.5 | Standard Deviation 10.53 | Units on a scale | |
| Double-Blind (DB) Induction Phase: Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score up to Day 28 | Esketamine 84 mg | -15.1 | Standard Deviation 12.21 | Units on a scale | |
| Double-Blind (DB) Induction Phase: Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score up to Day 28 | Placebo | -15.3 | Standard Deviation 11.68 | Units on a scale | |
| DB Induction Phase: Percentage of Participants With Response Based on MADRS Total Score | Esketamine 28 Milligrams (mg) | Day 2 | 22.0 | Percentage of participants | |
| DB Induction Phase: Percentage of Participants With Response Based on MADRS Total Score | Esketamine 56 mg | Day 2 | 13.2 | Percentage of participants | |
| DB Induction Phase: Percentage of Participants With Response Based on MADRS Total Score | Esketamine 84 mg | Day 2 | 10.0 | Percentage of participants | |
| DB Induction Phase: Percentage of Participants With Response Based on MADRS Total Score | Placebo | Day 2 | 9.0 | Percentage of participants | |
| DB Induction Phase: Percentage of Participants With Response Based on MADRS Total Score | Esketamine 28 Milligrams (mg) | Day 8 | 2.4 | Percentage of participants | |
| DB Induction Phase: Percentage of Participants With Response Based on MADRS Total Score | Esketamine 56 mg | Day 8 | 2.6 | Percentage of participants |
1 to 10 of 124Source ClinicalTrials.gov
See all 124 results by groupParticipant flow80
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-blind Induction Phase: 4 Weeks | STARTED | Esketamine 28 Milligrams (mg) | 41 | |
| Double-blind Induction Phase: 4 Weeks | STARTED | Esketamine 56 mg | 40 | |
| Double-blind Induction Phase: 4 Weeks | STARTED | Esketamine 84 mg | 41 | |
| Double-blind Induction Phase: 4 Weeks | STARTED | Placebo | 80 | |
| Double-blind Induction Phase: 4 Weeks | STARTED | Esketamine: Flexible Dose | 0 | |
| Double-blind Induction Phase: 4 Weeks | Responders | Esketamine 28 Milligrams (mg) | 13 | |
| Double-blind Induction Phase: 4 Weeks | Responders | Esketamine 56 mg | 11 | |
| Double-blind Induction Phase: 4 Weeks | Responders | Esketamine 84 mg | 17 | |
| Double-blind Induction Phase: 4 Weeks | Responders | Placebo | 27 | |
| Double-blind Induction Phase: 4 Weeks | Responders | Esketamine: Flexible Dose | 0 |
1 to 10 of 80Source ClinicalTrials.gov
See all 80 participant flowAdverse events756
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Palpitations | Cardiac disorders | Double Blind (DB): Esketamine 28 mg | 1 | 41 | |
| other | Palpitations | Cardiac disorders | DB: Esketamine 56 mg | 2 | 41 | |
| other | Palpitations | Cardiac disorders | DB: Esketamine 84 mg | 2 | 40 | |
| other | Palpitations | Cardiac disorders | DB: Placebo | 1 | 80 | |
| other | Palpitations | Cardiac disorders | DB Follow Up (FU): Esketamine 28 mg | 0 | 27 | |
| other | Palpitations | Cardiac disorders | DB FU: Esketamine 56 mg | 0 | 29 | |
| other | Palpitations | Cardiac disorders | DB FU: Esketamine 84 mg | 0 | 23 | |
| other | Palpitations | Cardiac disorders | DB FU: Placebo | 1 | 53 | |
| other | Palpitations | Cardiac disorders | Post-Treatment (PT) Phase: Esketamine 28 mg | 1 | 13 | |
| other | Palpitations | Cardiac disorders | PT Phase: Esketamine 56 mg | 0 | 11 |
1 to 10 of 756Source ClinicalTrials.gov
See all 756 adverse eventsAdverse event totals42
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Double Blind (DB): Esketamine 28 mg | 0 | 41 |
| Total, all-cause mortality | DB: Esketamine 56 mg | 0 | 41 |
| Total, all-cause mortality | DB: Esketamine 84 mg | 0 | 40 |
| Total, all-cause mortality | DB: Placebo | 0 | 80 |
| Total, all-cause mortality | DB Follow Up (FU): Esketamine 28 mg | 0 | 27 |
| Total, all-cause mortality | DB FU: Esketamine 56 mg | 0 | 29 |
| Total, all-cause mortality | DB FU: Esketamine 84 mg | 0 | 23 |
| Total, all-cause mortality | DB FU: Placebo | 0 | 53 |
| Total, all-cause mortality | Post-Treatment (PT) Phase: Esketamine 28 mg | 0 | 13 |
| Total, all-cause mortality | PT Phase: Esketamine 56 mg | 0 | 11 |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02918318
GET https://conductscience.org/api/trials/v1/NCT02918318/results?page=2