A Study to Explore the Efficacy of JNJ-67953964 in the Treatment of Depression

NCT03559192 | Completed Phase 2 Results FDA Drug

• 3 other identifiers: CR10848767953964MDD20012019-000695-41
• Study Type: interventional
• Target: 181
• Locations: 6 countries
• Sites: 53

Brief Summary

The purpose of this study is to evaluate the efficacy of JNJ-67953964 compared to placebo when administered as adjunctive treatment in participants with Major Depressive Disorder (MDD) partially responsive to selective serotonin reuptake inhibitor/ serotonin-norepinephrine reuptake inhibitor (SSRI/SNRI) treatment in terms of reduction of symptoms of depression, as assessed by the change from baseline on the Montgomery Asberg Depression Rating Scale (MADRS) in non-responders during the placebo lead-in period.

Conditions

Depressive Disorder, Major

Outcome Measures

Primary Outcomes (1)

• Change From Treatment Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score at Treatment Week 6 in Participants Who Were Non-Responders During Placebo Lead-in Period

  The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The scale consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), summed for a total possible score of 60. Higher scores represent a more severe condition. The MADRS evaluates apparent sadness, reported sadness, inner tension, sleep appetite, concentration, lassitude, inability to feel (interest level), pessimistic thoughts, and suicidal thoughts. Negative change from baseline indicates improvement.

  Treatment Baseline up to Week 6 of DB-treatment period

Secondary Outcomes (18)

• Change From Treatment Baseline in MADRS Total Score at Treatment Week 6

  Treatment Baseline up to Week 6 of DB-treatment period

• Number of Participants With Treatment-emergent Adverse Events (TEAEs) During DB Treatment Period

  Up to Week 6

• Change From Treatment Baseline in Snaith-Hamilton Pleasure Scale (SHAPS) Total Score at Treatment Week 6 (eITT Population)

  Treatment Baseline up to Week 6 of DB-treatment period

• Change From Treatment Baseline in SHAPS Total Score at Treatment Week 6 (fITT)

  Treatment Baseline up to Week 6 of DB-treatment period

• Change From Treatment Baseline in Clinical Global Impression - Severity (CGI-S) Score at Treatment Week 6 (eITT Population)

  Treatment Baseline up to Week 6 of DB-treatment period

Study Arms (3)

Lead-in Period: Placebo

PLACEBO COMPARATOR

Participants will receive matching placebo for the entire duration of the lead-in period.

Drug: Placebo

Treatment Period: JNJ-67953964 or Placebo

EXPERIMENTAL

Participants who respond or do not respond (based on reduction from lead-in baseline in MADRS) in the placebo lead-in period will receive either matching placebo or 10 (2\*5) milligram (mg) JNJ-67953964 capsules in a 1:1 ratio for 6 weeks.

Drug: JNJ-67953964; Drug: Placebo

Withdrawal Period: Placebo

PLACEBO COMPARATOR

Participants who complete the double-blind treatment period prior to the end of Week 11 will receive matching placebo for the remaining time of the treatment phase of the study.

Drug: Placebo

Interventions

JNJ-67953964 DRUG

JNJ-67953964 10 mg will be administered as two 5-mg capsules orally once daily.

Treatment Period: JNJ-67953964 or Placebo

Placebo DRUG

Matching placebo will be administered as 2 capsules orally once daily.

Lead-in Period: Placebo; Treatment Period: JNJ-67953964 or Placebo; Withdrawal Period: Placebo

Eligibility Criteria

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

You may qualify if:

• Have a Body Mass Index (BMI) between 18 and 35 kilogram per meter square (kg/m\^2) inclusive (BMI = weight/height\^2)
• Participants must be medically stable based on clinical laboratory tests, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening and baseline
• Participants must have a primary Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5) diagnosis of Major Depressive Disorder (MDD)
• The current episode should be less than 18 months
• Participants should be currently treated with an SSRI or SNRI at an adequate dose and for at least 6 weeks but no more than 12 months
• Have a Montgomery-Asberg Depression Rating Scale (MADRS) total score greater than or equal to (\>=) 25 at screening
• 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:

• History of documented gastric disease (including documented peptic ulcer disease, gastritis, upper gastrointestinal \[GI\] bleeding, esophagitis, or any GI precancerous condition), current clinically evident GI complaints
• Chronic use of a proton pump inhibitors (PPIs). History of incidental use of PPIs is allowed but should have been stopped at least 4 weeks before screening. A history of chronic nonsteroidal anti-inflammatory drug (NSAID) or aspirin use. (Low dose aspirin for example in cardiovascular disease prevention is allowed)
• Has a history of alcohol use disorder within the past year
• Has failed (no more than 25 percent \[%\] response on Antidepressant Treatment History Questionnaire \[ATRQ\]) three or more antidepressant treatments including the current Selective serotonin reuptake inhibitor/ serotonin-norepinephrine reuptake inhibitor (SSRI/SNRI) during the current depressive episode despite an adequate dose (per ATRQ) and duration (at least 6 weeks)
• Has signs or symptoms of Cushing's Disease, Addison's Disease, primary amenorrhea, or other evidence of significant medical disorders of the hypothalamus pituitary adrenal (HPA) axis
• Participant has received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 3 months before the planned first dose of study drug or has participated in any interventional clinical studies on MDD in the previous 1 year or is currently enrolled in an interventional study
• Has one or more of the following diagnoses:
• A primary DSM (5th edition) diagnosis of generalized anxiety disorder (GAD), panic disorder, obsessive compulsive disorder (OCD), posttraumatic stress disorder (PTSD). Participants with comorbid GAD, social anxiety disorder (SAD), or panic disorder for whom MDD is considered the primary diagnosis are not excluded
• A current diagnosis or diagnosis in the past 1 year of psychotic disorder, MDD with psychosis, anorexia nervosa or bulimia nervosa, chronic fatigue syndrome, bipolar disorder (BD), mental retardation, antisocial or borderline personality disorder, autism spectrum disorder
• Has a current or recent history of clinically significant suicidal ideation within the past 6 months, corresponding to a score of 4 (active suicidal ideation with some intent to act, without specific plan) or 5 (active suicidal ideation with specific plan and intent) for ideation on the Colombia suicide severity rating scale (C-SSRS), or a history of suicidal behavior within the past 1 year
• Ongoing psychological treatments (example, Cognitive Behavior Therapy, Interpersonal Psychotherapy, Psychodynamic Psychotherapy, etcetera \[etc.\]), initiated within 1 month prior to the screening phase. A participant who has been receiving ongoing psychological treatment for a period of greater than 1 month from the screening visit is eligible, if the investigator deems the psychological treatment to be of stable duration and frequency
• Participant has a history of substance use disorder according to DSM-5 criteria, except nicotine or caffeine, within 6 months before screening. Mild cases can be reviewed on a case by case basis. Participants who have completed a treatment for (alcohol) addiction more than 1 year prior to first dose administration, may be included if the risk of relapse is considered minimal, total duration of alcohol use disorder was less than a year, and no significant abnormalities are shown in clinical laboratory or other pre-dose safety assessments
• Participant has used:
• Monoamine oxidase inhibitors (MAOIs) within 12 weeks before screening
• St. John's wort, ephedra, ginkgo, ginseng, or kava within 2 weeks before screening

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (53)

Noble Clinical Research

Tucson, Arizona, 85704, United States

Location

Preferred Research Partners

Little Rock, Arkansas, 72211, United States

Location

Behavioral Research Specialists LLC

Glendale, California, 91206, United States

Location

NRC Research Institute

Orange, California, 92868, United States

Location

Artemis Institute for Clinical Research

Riverside, California, 92503, United States

Location

Artemis Institute for Clinical Research

San Marcos, California, 92078, United States

Location

Pacific Clinical Research Medical Group

Upland, California, 91786, United States

Location

Innova Clinical Trials

Miami, Florida, 33133, United States

Location

Galiz Research

Miami Springs, Florida, 33166, United States

Location

APG Research LLC

Orlando, Florida, 32803, United States

Location

Olympian Clinical Research

Tampa, Florida, 33614, United States

Location

Meridien Research

Tampa, Florida, 33634, United States

Location

Atlanta Behavioral Research, LLC

Atlanta, Georgia, 30338, United States

Location

Chicago Research Center

Chicago, Illinois, 60634, United States

Location

Psychiatric Medicine Associates LLC

Skokie, Illinois, 60076, United States

Location

Lake Charles Clinical Trials

Lake Charles, Louisiana, 70629, United States

Location

Princeton Medical Institute

Princeton, New Jersey, 08540, United States

Location

Integrative Clinical Trials LLC

Brooklyn, New York, 11229, United States

Location

Richmond Behavioural Associates

Staten Island, New York, 10312, United States

Location

Clinical Trials of America

Hickory, North Carolina, 28601, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Midwest Clinical Research Center

Dayton, Ohio, 45417, United States

Location

IPS Research Company

Oklahoma City, Oklahoma, 73106, United States

Location

Paradigm Research Professionals, LLC

Oklahoma City, Oklahoma, 73118, United States

Location

Lehigh Center for Clinical Research

Allentown, Pennsylvania, 18104, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Clinical NeuroScience Solutions Inc

Memphis, Tennessee, 38119, United States

Location

Advanced Clinical Research

West Jordan, Utah, 84088, United States

Location

Emovis GmbH

Berlin, 10629, Germany

Location

Somni Bene GmbH

Schwerin, 19053, Germany

Location

ARENSIA

Chisinau, MD2025, Moldova

Location

Clinical Psychiatric Hospital #3 Named After V.A. Gilyarovsky

Moscow, 107076, Russia

Location

Orenburg Regional Clinical Psychiatric Hospital #1

Orenburg, Russia

Location

Medical and Rehabilitation Research Center Phoenix

Rostov-on-Don, 344002, Russia

Location

St-Petersburg Bekhterev Psychoneurological Research Institute

Saint Petersburg, 192019, 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

Research Institute of Mental Health

Tomsk, 634014, Russia

Location

Sverdlovsk Regional Clinical Psychiatric Hospital

Yekaterinburg, Russia

Location

MNCE of Kyiv RC Regional Psychiatric and Narcological Medical Association

Hlevakha, 8630, 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

Cnce 'Kyiv City Psychoneurological Hospital #2' of Executive Body of Kyiv City Council (Kcsa)

Kyiv, 2660, 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

MAC Clinical Research

Barnsley, S75 3DL, United Kingdom

Location

MAC Clinical Research

Blackpool, FY2 0JH, United Kingdom

Location

MAC Clinical Research

Liverpool, L34 1BH, United Kingdom

Location

Hammersmith Medicines Research Ltd

London, NW10 7EW, United Kingdom

Location

MAC Clinical Research

Manchester, M139NQ, United Kingdom

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Aticaprant

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: Senior Director
• 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: June 6, 2018
• First Posted: June 18, 2018
• Study Start: July 16, 2018
• Primary Completion: May 6, 2020
• Study Completion: May 6, 2020
• Last Updated: April 29, 2025
• Results First Posted: June 26, 2023

Record last verified: 2025-04

Locations

MO (1); UA (6); US (28); RU (11); GB (5); DE (2)