A Study of JNJ-61393215 in the Treatment of Depression

NCT04080752 | Completed Phase 2 Results FDA Drug

• 3 other identifiers: CR1086552019-001683-2961393215MDD2001
• Study Type: interventional
• Target: 222
• Locations: 5 countries
• Sites: 35

Brief 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 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.

Conditions

Major Depressive Disorder With Anxious Distress

Outcome Measures

Primary Outcomes (1)

• 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).

  Baseline and Week 6

Secondary Outcomes (10)

• Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score at Week 6

  Baseline and Week 6

• Change From Baseline in HAM-A Total Score at Weeks 2 and 4

  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

  Baseline and Week 6

• Change From Baseline in HAM-A Total Score in Participants With a Baseline HAM-A Score >=20 at Week 6

  Baseline and Week 6

• Change From Baseline in Generalized Anxiety Disorder-7 (GAD-7) Total Score at Week 6

  Baseline and Week 6

Study Arms (2)

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.

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.

Drug: Placebo

Interventions

JNJ-61393215 DRUG

JNJ-61393215 will be administrated orally.

Also known as: Orexin-1

JNJ-61393215 135 milligram (mg)

Placebo DRUG

Matching placebo will be administered orally.

Placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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 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
• 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 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (35)

Collaborative NeuroScience Network

Garden Grove, California, 92845, United States

Location

Atlanta Institute

Alpharetta, Georgia, 30022, United States

Location

Atlanta Center for Medical Research

Atlanta, Georgia, 30331, United States

Location

The Medical Research Network, LLC

New York, New York, 10128, United States

Location

Richmond Behavioural Associates

Staten Island, New York, 10312, United States

Location

Ohio State University

Columbus, Ohio, 43220, United States

Location

IPS Research Company

Oklahoma City, Oklahoma, 73106, United States

Location

Suburban Research Associates

Media, Pennsylvania, 19063, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75235, United States

Location

ARENSIA

Chisinau, MD2025, Moldova

Location

City Clinical Psychiatric Hopsital 3

Moscow, 107076, Russia

Location

Nizny Novgorod clinical psychiatric hospital 1

Nizny Novgorod, 603155, Russia

Location

Orenburg Regional Clinical Psychiatric Hospital #1

Orenburg, Russia

Location

Medical and Rehabilitation Research Center Phoenix

Rostov-on-Don, 344010, Russia

Location

Psychoneurological dispensary 10

Saint Petersburg, 190121, Russia

Location

City Psychiatric hospital 7 named after I.P.Pavlov

Saint Petersburg, 199034, Russia

Location

Psychoneurological dispensary 1

Saint Petersburg, 199178, Russia

Location

SHI 'Saratov City Clinical Hospital 2 n.a V.I. Razumovsky

Saratov, 410028, Russia

Location

Saratov Regional Psychiatric hospital named after St. Sofia

Saratov, 410060, Russia

Location

Engels psychiatric hospital

Saratov Region, 413124, Russia

Location

Psychoneurological Dispensary #4

St.Peterburg, 197110, Russia

Location

Stavropol Region Psychiatric Hospital #2

Stavropol, 357034, Russia

Location

Research Institute of Mental Health

Tomsk, 634014, Russia

Location

MNCE of Kyiv RC Regional Psychiatric and Narcological Medical Association

Hlevakha, 8630, Ukraine

Location

CNCE'Precarpathian Regional Clinical Mental Health Center Ivano-Frankivsk RC'

Ivano-Frankivsk, 76011, Ukraine

Location

Mnpe of Kharkiv Regional Council 'Regional Clinical Psychiatric Hospital #3'

Kharkiv, 61068, Ukraine

Location

CNPE'Kherson Regional Institution of Mental Care'of Kherson Regional Council

Kherson, 73488, Ukraine

Location

Kyiv Railway Station Clinical Hospital #2

Kyiv, 03049, Ukraine

Location

Mnpe 'Regional Clinical Psychiatric Hospital of Kirovohrad Regional Council'

Nove, 25491, Ukraine

Location

CNCE 'Cherkasy Regional Psychiatric Hospital of Cherkasy Regional Council'

Smila, 20708, Ukraine

Location

CNCE 'Vinnytsya RC Psychoneurological Hospital n.a. O.I. Yushchenko Vinnytsya RC'

Vinnytsia, 21005, Ukraine

Location

MAC Clinical Research

Barnsley, S75 3DL, United Kingdom

Location

MAC Clinical Research

Liverpool, L341BH, United Kingdom

Location

Kings College London

London, SE5 8AZ, United Kingdom

Location

MAC Clinical Research

Manchester, M139NQ, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 40215570 DERIVED

MeSH Terms

Interventions

Hcrtr1 protein, mouse

Limitations and Caveats

The study was limited to a single dose level. During the study, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic emerged. Public health measures required progressive restriction of movement of participants, site staff, and sponsor staff. The recruitment and enrollment were halted on 17 March 2020. All ongoing participants were permitted to continue the study if they were able to attend the on-site scheduled visits.

Results Point of Contact

• Title: BE-R and D-Research Physician - Seni
• Organization: Janssen Research & Development, LLC

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2019
• First Posted: September 6, 2019
• Study Start: September 17, 2019
• Primary Completion: September 2, 2021
• Study Completion: September 2, 2021
• Last Updated: April 29, 2025
• Results First Posted: September 29, 2022

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

GB (4); UA (8); US (9); MO (1); RU (13)