A Study of JNJ-61393215 in the Treatment of Depression

NCT ID: NCT04080752

Last Updated: 2025-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 222 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-17
• Study Completion Date: 2021-09-02

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

JNJ-61393215 135 milligram (mg)

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.

Group Type: EXPERIMENTAL

JNJ-61393215

Intervention Type: DRUG

JNJ-61393215 will be administrated orally.

Placebo

Participants will receive matching placebo for 6 weeks along with the prescribed standard oral antidepressants (without dose change) throughout the study.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching placebo will be administered orally.

Interventions

JNJ-61393215

JNJ-61393215 will be administrated orally.

Intervention Type: DRUG

Placebo

Matching placebo will be administered orally.

Intervention Type: DRUG

Other Intervention Names

Orexin-1

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Collaborative NeuroScience Network

Garden Grove, California, United States

Atlanta Institute

Alpharetta, Georgia, United States

Atlanta Center for Medical Research

Atlanta, Georgia, United States

The Medical Research Network, LLC

New York, New York, United States

Richmond Behavioural Associates

Staten Island, New York, United States

Ohio State University

Columbus, Ohio, United States

IPS Research Company

Oklahoma City, Oklahoma, United States

Suburban Research Associates

Media, Pennsylvania, United States

UT Southwestern Medical Center

Dallas, Texas, United States

ARENSIA

Chisinau, , Moldova

City Clinical Psychiatric Hopsital 3

Moscow, , Russia

Nizny Novgorod clinical psychiatric hospital 1

Nizny Novgorod, , Russia

Orenburg Regional Clinical Psychiatric Hospital #1

Orenburg, , Russia

Medical and Rehabilitation Research Center Phoenix

Rostov-on-Don, , Russia

Psychoneurological dispensary 10

Saint Petersburg, , Russia

City Psychiatric hospital 7 named after I.P.Pavlov

Saint Petersburg, , Russia

Psychoneurological dispensary 1

Saint Petersburg, , Russia

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

Saratov, , Russia

Saratov Regional Psychiatric hospital named after St. Sofia

Saratov, , Russia

Engels psychiatric hospital

Saratov Region, , Russia

Psychoneurological Dispensary #4

St.Peterburg, , Russia

Stavropol Region Psychiatric Hospital #2

Stavropol, , Russia

Research Institute of Mental Health

Tomsk, , Russia

MNCE of Kyiv RC Regional Psychiatric and Narcological Medical Association

Hlevakha, , Ukraine

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

Ivano-Frankivsk, , Ukraine

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

Kharkiv, , Ukraine

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

Kherson, , Ukraine

Kyiv Railway Station Clinical Hospital #2

Kyiv, , Ukraine

Mnpe 'Regional Clinical Psychiatric Hospital of Kirovohrad Regional Council'

Nove, , Ukraine

CNCE 'Cherkasy Regional Psychiatric Hospital of Cherkasy Regional Council'

Smila, , Ukraine

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

Vinnytsia, , Ukraine

MAC Clinical Research

Barnsley, , United Kingdom

MAC Clinical Research

Liverpool, , United Kingdom

Kings College London

London, , United Kingdom

MAC Clinical Research

Manchester, , United Kingdom

Countries

United States; Moldova; Russia; Ukraine; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 40215570 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2019-001683-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

61393215MDD2001

Identifier Type: OTHER

Identifier Source: secondary_id

CR108655

Identifier Type: -

Identifier Source: org_study_id