Major Depressive Disorder With Anxious DistressPhase 2NCT04080752
A Study of JNJ-61393215 in the Treatment of Depression
A Phase 2 study testing JNJ-61393215 in people with Major Depressive Disorder With Anxious Distress, run by Janssen Research & Development, LLC at 35 sites in 5 countries.
Trial summary
The purpose of this study is to evaluate the efficacy of JNJ-61393215 as adjunctive treatment compared to adjunctive placebo, as assessed by the change from baseline to week 6 on a 17-item Hamilton Depression Rating Scale (HDRS-17) in participants with major depressive disorder (MDD) with anxious distress with a score… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Major Depressive Disorder With Anxious Distress
- What is being tested?
- JNJ-61393215
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 222 participants
- Where
- 35 sitesin 5 countries
- Study dates
- 17 Sep 2019to 2 Sep 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants must have a body mass index (BMI) between 18 and 36 kilogram per meter square (kg/m^2)
- Participants must have a primary diagnostic and statistical manual of mental disorders, 5th edition (DSM-5) diagnosis of major depressive disorder (MDD) with anxious distress, as assessed by the mini international neuropsychiatric inventory 7.0. Plus (MINI). Participants with a diagnosis of comorbid generalized anxiety disorder (GAD), post-traumatic stress disorder, persistent depressive disorder, attention deficit hyperactivity disorder (ADHD), social anxiety disorder or nicotine/caffeine dependence may be included, if MDD is primary diagnosis
- Participants must have an inventory of depressive symptomatology, clinician rating-30 (IDS-C30) total score greater than or equal to (>=) 35 (moderate to severe depression)
- Participant must not have received more than 3 failed antidepressant treatments (of adequate dose and duration), including their current treatment, in the current episode of depression, as documented by the massachusetts general hospital antidepressant treatment history questionnaire (MGH-ATRQ)
- Participant must be currently receiving 1 of the following antidepressants for at least 6 weeks duration at screening, at an adequate therapeutic dose, as determined by the MGH-ATRQ and should remain on a stable dose throughout the study: bupropion, citalopram, escitalopram, sertraline, paroxetine, venlafaxine, desvenlafaxine, duloxetine, fluoxetine, vilazodone, vortioxetine, mirtazapine, agomelatine, nortriptyline, imipramine, amitriptyline and levomilnacipran
- Participants must have a suboptimal response (improvement <50%) to the antidepressant used as their current treatment, as measured by the MGH-ATRQ
- A woman of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test before the first dose
Who cannot join
- Participant has any other psychiatric condition including but not limited to: MDD with current psychotic features, bipolar disorder (including lifetime diagnosis), obsessive-compulsive disorder, borderline personality disorder, eating disorder (example: bulimia, anorexia nervosa), or schizophrenia (lifetime)
- Age of onset of depression is after 55 years of age
- Participant has a history of alcohol or substance use disorder (abuse/dependence) within 6 months prior to screening (nicotine and caffeine dependence are not exclusionary)
- Participant has a current or recent (within the past year) history of clinically significant suicidal ideation (corresponding to a score of >= 3 for ideation) or any suicidal behavior within the past year, as validated on the Colombia suicide severity rating scale (C-SSRS) at screening or baseline
- Length of current major depressive episode >60 months
- Participant has organic brain disease or dementia or has known or suspected intellectual development disorder
Show all 11Show fewer
- Participant has been treated with at least one of the following treatments: (a) electroconvulsive therapy in the current episode; (b) deep brain stimulation (lifetime); (c) repetitive transcranial magnetic stimulation within 4 weeks prior to baseline visit
- Participant has any clinically relevant medical condition that could potentially alter the absorption, metabolism, or excretion of the study intervention, such as liver disease or renal disease
- Participant has a relevant history of any significant and/or unstable cardiovascular, respiratory, neurological (including seizures - uncomplicated childhood febrile seizures with no sequelae are not exclusionary) or significant cerebrovascular, renal, hepatic, dermatologic, hematologic, gastrointestinal or endocrine diseases. Hospitalization for cardiovascular event (myocardial infarction, unstable angina, stroke, transient ischemic attack) within 3 months prior to the first administration of study drug is exclusionary. Diabetes mellitus be allowed when the participant is stable (HbA1c less than 7.5% or 58 mmol/mol)
- Participant has a clinically significant abnormal physical examination, vital signs or 12-lead electrocardiogram (ECG) at screening or baseline Minor deviations in ECG, which are not considered to be of clinical significance to the investigator, are acceptable.If at screening visit QTcB or QTcF interval >=450 ms for males or >=470 ms for females, or >480 ms if bundle branch block and prolongation of the QTc interval are present;participant is excluded
- Participant has a history of known demyelinating diseases such as multiple sclerosis or optic neuritis
Trial locations and contacts
35 sites in 5 countries.
35 sites in 5 countries
Russia13 sites
City Clinical Psychiatric Hopsital 3
Moscow, 107076
Nizny Novgorod clinical psychiatric hospital 1
Nizny Novgorod, 603155
Orenburg Regional Clinical Psychiatric Hospital #1
Orenburg
Medical and Rehabilitation Research Center Phoenix
Rostov-on-Don, 344010
Psychoneurological dispensary 10
Saint Petersburg, 190121
City Psychiatric hospital 7 named after I.P.Pavlov
Saint Petersburg, 199034
Psychoneurological dispensary 1
Saint Petersburg, 199178
SHI 'Saratov City Clinical Hospital 2 n.a V.I. Razumovsky
Saratov, 410028
Saratov Regional Psychiatric hospital named after St. Sofia
Saratov, 410060
Engels psychiatric hospital
Saratov Region, 413124
Psychoneurological Dispensary #4
St.Peterburg, 197110
Stavropol Region Psychiatric Hospital #2
Stavropol, 357034
Research Institute of Mental Health
Tomsk, 634014
United States9 sites
Atlanta Institute
Alpharetta, Georgia, 30022
Atlanta Center for Medical Research
Atlanta, Georgia, 30331
Ohio State University
Columbus, Ohio, 43220
UT Southwestern Medical Center
Dallas, Texas, 75235
Collaborative NeuroScience Network
Garden Grove, California, 92845
Suburban Research Associates
Media, Pennsylvania, 19063
The Medical Research Network, LLC
New York, New York, 10128
IPS Research Company
Oklahoma City, Oklahoma, 73106
Richmond Behavioural Associates
Staten Island, New York, 10312
Ukraine8 sites
MNCE of Kyiv RC Regional Psychiatric and Narcological Medical Association
Hlevakha, 8630
CNCE'Precarpathian Regional Clinical Mental Health Center Ivano-Frankivsk RC'
Ivano-Frankivsk, 76011
Mnpe of Kharkiv Regional Council 'Regional Clinical Psychiatric Hospital #3'
Kharkiv, 61068
CNPE'Kherson Regional Institution of Mental Care'of Kherson Regional Council
Kherson, 73488
Kyiv Railway Station Clinical Hospital #2
Kyiv, 03049
Mnpe 'Regional Clinical Psychiatric Hospital of Kirovohrad Regional Council'
Nove, 25491
CNCE 'Cherkasy Regional Psychiatric Hospital of Cherkasy Regional Council'
Smila, 20708
CNCE 'Vinnytsya RC Psychoneurological Hospital n.a. O.I. Yushchenko Vinnytsya RC'
Vinnytsia, 21005
United Kingdom4 sites
MAC Clinical Research
Barnsley, S75 3DL
MAC Clinical Research
Liverpool, L341BH
Kings College London
London, SE5 8AZ
MAC Clinical Research
Manchester, M139NQ
About this study
Official title: Double-Blind, Placebo-Controlled, Multi-Center Study Investigating the Efficacy, Safety, and Tolerability of JNJ-61393215 as Adjunctive Treatment in Adults With Major Depressive Disorder With Anxious Distress With Suboptimal Response to Standard Antidepressants
The purpose of this study is to evaluate the efficacy of JNJ-61393215 as adjunctive treatment compared to adjunctive placebo, as assessed by the change from baseline to week 6 on a 17-item Hamilton Depression Rating Scale (HDRS-17) in participants with major depressive disorder (MDD) with anxious distress with a score greater than or equal to (>=) 2 on item 26 or 27 of the Inventory of Depressive Symptomatology, Clinician Rating -30 (IDS-C30), who have a suboptimal response to current treatment with a standard antidepressant.
- Being tested
- JNJ-61393215, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-61393215Drug
Also called Orexin-1
JNJ-61393215 will be administrated orally.
PlaceboDrug
Matching placebo will be administered orally.
| Study group | Role | What they receive |
|---|---|---|
| JNJ-61393215 135 milligram (mg) | Experimental | Participants will receive JNJ-61393215 135 mg (3*45 mg capsules) orally once daily for 6 weeks along with the prescribed standard oral antidepressants (without dose change) throughout the study. Receives: Drug: JNJ-61393215 |
| Placebo | Placebo comparator | Participants will receive matching placebo for 6 weeks along with the prescribed standard oral antidepressants (without dose change) throughout the study. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Hamilton Depression Rating Scale-17 (HDRS-17) Total Score at Week 6
Change from baseline in HDRS-17 total score at Week 6 was reported. The HDRS-17 is a clinician-administered rating scale designed to assess the severity of symptoms in participants diagnosed with depression with a score range of 0 to 52. Each of the 17 items is rated by the clinician on either a 3-point (0 to 2) or a 5-point scale (0 to 4). The point scale used a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). A total score (range: 0 to 52) was calculated by adding the scores of all 17 items. For each item as well as the total score, a higher score represents a more severe condition (greater depression).
Measured: Baseline and Week 6
Secondary outcomes (10)
Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score at Week 6
Change from baseline in HAM-A total score at Week 6 was reported. HAM-A is a 14-item scale designed to measure severity of anxiety-related symptoms in participants. Each question reflects a symptom of general anxiety, including physical anxiety and mental anxiety. Each item was rated on a 5-point scale ranged from 0 (not present) to 4 (maximum anxiety). The total score was sum of 14 items scores and it ranged from 0 (normal) to 56 (severe), where higher score indicated greater degree of anxiety symptom. The total score was categorized as 0-13: normal range, 14-17: mild severity, 18-24: mild to moderate severity, 25-30: moderate to severe, and >=31: severe. Negative change in score indicates improvement.
Measured: Baseline and Week 6
Change From Baseline in HAM-A Total Score at Weeks 2 and 4
Change from baseline in HAM-A total score at Weeks 2 and 4 were reported. HAM-A is a 14-item scale designed to measure severity of anxiety-related symptoms in participants. Each question reflects a symptom of general anxiety, including physical anxiety and mental anxiety. Each item was rated on a 5-point scale ranged from 0 (not present) to 4 (maximum anxiety). The total score was sum of 14 items scores and it ranged from 0 (normal) to 56 (severe), where higher score indicated greater degree of anxiety symptom. The total score was categorized as 0-13: normal range, 14-17: mild severity, 18-24: mild to moderate severity, 25-30: moderate to severe, and >=31: severe. Negative change in score indicates improvement.
Measured: Baseline, Week 2, and Week 4
Change From Baseline in HDRS-17 Total Score in Participants With a Baseline HAM-A Score >=20 at Week 6
Change from baseline in HDRS-17 total score in participants with a baseline HAM-A score >=20 at Week 6 was reported. The HDRS-17 is a clinician-administered rating scale designed to assess the severity of symptoms in participants diagnosed with depression with a score range of 0 to 52. Each of the 17 items is rated by the clinician on either a 3-point (0 to 2) or a 5-point scale (0 to 4). The point scale used a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). A total score (range: 0 to 52) was calculated by adding the scores of all 17 items. For each item as well as the total score, a higher score represents a more severe condition (greater depression).
Measured: Baseline and Week 6
Change From Baseline in HAM-A Total Score in Participants With a Baseline HAM-A Score >=20 at Week 6
Change from baseline in HAM-A total score in participants with a baseline HAM-A score >=20 at Week 6 was reported. HAM-A is a 14-item scale designed to measure severity of anxiety-related symptoms in participants. Each question reflects a symptom of general anxiety, including physical anxiety and mental anxiety. Each item was rated on a 5-point scale ranged from 0 (not present) to 4 (maximum anxiety). The total score was sum of 14 items scores and it ranged from 0 (normal) to 56 (severe), where higher score indicated greater degree of anxiety symptom. The total score was categorized as 0-13: normal range, 14-17: mild severity, 18-24: mild to moderate severity, 25-30: moderate to severe, and >=31: severe. Negative change in score indicates improvement.
Measured: Baseline and Week 6
Change From Baseline in Generalized Anxiety Disorder-7 (GAD-7) Total Score at Week 6
Change from baseline in GAD-7 total score at Week 6 was reported. The GAD-7 is a brief and validated 7-item self-reported 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).
Measured: Baseline and Week 6
Change From Baseline in Patient Health Questionnaire (PHQ-9) Total Score at Weeks 2 and 4
Change From baseline in PHQ-9 total score at Weeks 2 and 4. The PHQ-9 is a 9-item, Patient Reported Outcome (PRO) measure to assess depressive symptoms. The scale scores each of the 9 symptom domains of the Diagnostic and Statistical Manual of Mental Disorders-5th Edition (DSM-5) major depressive disorder (MDD) criteria. Each item is rated on a 4 point scale (0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day). The participants item responses are summed to provide a total score (range of 0 to 27), with higher scores indicating greater severity of depressive symptoms. The severity of the PHQ-9 is categorized as follows: None-minimal (0-4), Mild (5-9), Moderate (10-14), Moderately Severe (15-19) and Severe (20-27).
Measured: Baseline, Week 2, and Week 4
Change From Baseline in HDRS-17 Total Score at Weeks 2 and 4
Change From baseline in HDRS-17 total score at Weeks 2 and 4. The HDRS-17 is a clinician-administered rating scale designed to assess the severity of symptoms in participants diagnosed with depression with a score range of 0 to 52. Each of the 17 items is rated by the clinician on either a 3-point (0 to 2) or a 5-point scale (0 to 4). The point scale used a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). A total score (range: 0 to 52) was calculated by adding the scores of all 17 items. For each item as well as the total score, a higher score represents a more severe condition (greater depression).
Measured: Baseline, Week 2, and Week 4
Number of Participants With Treatment-emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs were events during the initiation of study drug up till follow-up period.
Measured: Up to 8 weeks
Total Plasma Concentration of JNJ-61393215
Total plasma concentration of JNJ-61393215 was reported. The concentrations of JNJ-61393215 were measured using a validated, specific, and sensitive liquid chromatography-mass spectrometry/mass spectrometry (LC-MS/MS) method.
Measured: 1-4 hours postdose on Day 1; Predose and 1-4 hours post dose on Days 15, 29, and 43
Plasma Protein Binding (PPB): Percentage of JNJ-61393215 Unbound
Percentage of JNJ-61393215 unbound was determined by using a liquid chromatography-mass spectrometry/mass spectrometry (LC-MS/MS) method. The protein binding was assessed by spiking plasma samples with radiolabeled JNJ-61393215.
Measured: Predose and 1-4 hours post dose on Day 43
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start17 Sep 2019
- Primary completion2 Sep 2021
- Study completion2 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive Disorder With Anxious DistressStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04080752
- Sponsor's protocol ID
- CR108655
- Other IDs
- 2019-001683-29, 61393215MDD2001, 2019
- Status last verified
- Apr 2025
- First submitted
- 4 Sep 2019
- Last updated
- 29 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Publications
Schmidt ME, Moyer JA, Kezic I, Zhou X, Samtani MN, Bleys C, Dallas S, Salvadore G, Drevets WC. Efficacy, safety, and tolerability of JNJ-61393215 (tebideutorexant), a selective orexin-1 receptor antagonist, as adjunctive treatment for major depressive disorder with anxious distress: A double-blind, placebo-controlled, randomized phase 2a study. Eur Neuropsychopharmacol. 2025 Jun;95:14-23. doi: 10.1016/j.euroneuro.2025.03.007. Epub 2025 Apr 13.
PubMed 40215570
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind, Placebo-Controlled, Multi-Center Study Investigating the Efficacy, Safety, and Tolerability of JNJ-61393215 as Adjunctive Treatment in Adults With Major Depressive Disorder With Anxious Distress With Suboptimal Response to Standard Antidepressants
- ClinicalTrials.gov ID
- NCT04080752
- Acronym / sponsor ID
- CR108655
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 222 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 17 Sep 2019 (actual)
- Primary completion
- 2 Sep 2021 (actual)
- Study completion
- 2 Sep 2021 (actual)
- First posted
- 6 Sep 2019 (actual)
- Results
- Posted 29 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy of JNJ-61393215 as adjunctive treatment compared to adjunctive placebo, as assessed by the change from baseline to week 6 on a 17-item Hamilton Depression Rating Scale (HDRS-17) in participants with major depressive disorder (MDD) with anxious distress with a score greater than or equal to (>=) 2 on item 26 or 27 of the Inventory of Depressive Symptomatology, Clinician Rating -30 (IDS-C30), who have a suboptimal response to current treatment with a standard antidepressant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JNJ-61393215 135 milligram (mg) | Experimental | Drug: JNJ-61393215Participants will receive JNJ-61393215 135 mg (3*45 mg capsules) orally once daily for 6 weeks along with the prescribed standard oral antidepressants (without dose change) throughout the study. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive matching placebo for 6 weeks along with the prescribed standard oral antidepressants (without dose change) throughout the study. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Participants must have a body mass index (BMI) between 18 and 36 kilogram per meter square (kg/m^2)
- Participants must have a primary diagnostic and statistical manual of mental disorders, 5th edition (DSM-5) diagnosis of major depressive disorder (MDD) with anxious distress, as assessed by the mini international neuropsychiatric inventory 7.0. Plus (MINI). Participants with a diagnosis of comorbid generalized anxiety disorder (GAD), post-traumatic stress disorder, persistent depressive disorder, attention deficit hyperactivity disorder (ADHD), social anxiety disorder or nicotine/caffeine dependence may be included, if MDD is primary diagnosis
- Participants must have an inventory of depressive symptomatology, clinician rating-30 (IDS-C30) total score greater than or equal to (>=) 35 (moderate to severe depression)
- Participant must not have received more than 3 failed antidepressant treatments (of adequate dose and duration), including their current treatment, in the current episode of depression, as documented by the massachusetts general hospital antidepressant treatment history questionnaire (MGH-ATRQ)
- Participant must be currently receiving 1 of the following antidepressants for at least 6 weeks duration at screening, at an adequate therapeutic dose, as determined by the MGH-ATRQ and should remain on a stable dose throughout the study: bupropion, citalopram, escitalopram, sertraline, paroxetine, venlafaxine, desvenlafaxine, duloxetine, fluoxetine, vilazodone, vortioxetine, mirtazapine, agomelatine, nortriptyline, imipramine, amitriptyline and levomilnacipran
Key exclusion criteria (11 listed)
- Participant has any other psychiatric condition including but not limited to: MDD with current psychotic features, bipolar disorder (including lifetime diagnosis), obsessive-compulsive disorder, borderline personality disorder, eating disorder (example: bulimia, anorexia nervosa), or schizophrenia (lifetime)
- Age of onset of depression is after 55 years of age
- Participant has a history of alcohol or substance use disorder (abuse/dependence) within 6 months prior to screening (nicotine and caffeine dependence are not exclusionary)
- Participant has a current or recent (within the past year) history of clinically significant suicidal ideation (corresponding to a score of >= 3 for ideation) or any suicidal behavior within the past year, as validated on the Colombia suicide severity rating scale (C-SSRS) at screening or baseline
- Length of current major depressive episode >60 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JNJ-61393215Also: Orexin-1JNJ-61393215 will be administrated orally. | Drug | JNJ-61393215 135 milligram (mg) |
| PlaceboMatching placebo will be administered orally. | Drug | Placebo |
Primary outcome
Change From Baseline in Hamilton Depression Rating Scale-17 (HDRS-17) Total Score at Week 6
Time frame: Baseline and Week 6
Change from baseline in HDRS-17 total score at Week 6 was reported. The HDRS-17 is a clinician-administered rating scale designed to assess the severity of symptoms in participants diagnosed with depression with a score range of 0 to 52. Each of the 17 items is rated by the clinician on either a 3-point (0 to 2) or a 5-point scale (0 to 4). The point scale used a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). A total score (range: 0 to 52) was calculated by adding the scores of all 17 items. For each item as well as the total score, a higher score represents a more severe condition (greater depression).
10 secondary outcomes
Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score at Week 6
Time frame: Baseline and Week 6
Change From Baseline in HAM-A Total Score at Weeks 2 and 4
Time frame: Baseline, Week 2, and Week 4
Change From Baseline in HDRS-17 Total Score in Participants With a Baseline HAM-A Score >=20 at Week 6
Time frame: Baseline and Week 6
Change From Baseline in HAM-A Total Score in Participants With a Baseline HAM-A Score >=20 at Week 6
Time frame: Baseline and Week 6
Change From Baseline in Generalized Anxiety Disorder-7 (GAD-7) Total Score at Week 6
Time frame: Baseline and Week 6
Change From Baseline in Patient Health Questionnaire (PHQ-9) Total Score at Weeks 2 and 4
Time frame: Baseline, Week 2, and Week 4
Change From Baseline in HDRS-17 Total Score at Weeks 2 and 4
Time frame: Baseline, Week 2, and Week 4
Number of Participants With Treatment-emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability
Time frame: Up to 8 weeks
Total Plasma Concentration of JNJ-61393215
Time frame: 1-4 hours postdose on Day 1; Predose and 1-4 hours post dose on Days 15, 29, and 43
Plasma Protein Binding (PPB): Percentage of JNJ-61393215 Unbound
Time frame: Predose and 1-4 hours post dose on Day 43
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40215570Schmidt ME, Moyer JA, Kezic I, Zhou X, Samtani MN, Bleys C, Dallas S, Salvadore G, Drevets WC. Efficacy, safety, and tolerability of JNJ-61393215 (tebideutorexant), a selective orexin-1 receptor antagonist, as adjunctive treatment for major depressive disorder with anxious distress: A double-blind, placebo-controlled, randomized phase 2a study. Eur Neuropsychopharmacol. 2025 Jun;95:14-23. doi: 10.1016/j.euroneuro.2025.03.007. Epub 2025 Apr 13.
- Individual participant dataSharing planned: Yes. The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
35 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing JNJ-61393215 in people with Major Depressive Disorder With Anxious Distress, run by Janssen Research & Development, LLC at 35 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in Russia, United States, Ukraine, United Kingdom, Moldova. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Hamilton Depression Rating Scale-17 (HDRS-17) Total Score at Week 6 (time frame: Baseline and Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04080752, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2025.