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

NCT ID: NCT03559192

Last Updated: 2025-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 181 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-16
• Study Completion Date: 2020-05-06

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

Study Design

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

Study Groups

Lead-in Period: Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Treatment Period: JNJ-67953964 or Placebo

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.

Group Type: EXPERIMENTAL

JNJ-67953964

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

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

Withdrawal Period: Placebo

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

JNJ-67953964

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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)

1. The current episode should be less than 18 months

2. 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

3. 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

Exclusion Criteria

• 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:

1. 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

2. 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:

1. Monoamine oxidase inhibitors (MAOIs) within 12 weeks before screening

2. St. John's wort, ephedra, ginkgo, ginseng, or kava within 2 weeks before screening

3. Antipsychotic drugs (D2-antagonists) within 2 weeks before screening. However, Seroquel (quetiapine) in a dose less than or equals to (<=)100 milligram (mg) is allowed when used in a stable dose for at least 8 weeks prior to screening. Quetiapine treatment should be continued unchanged during the study

4. Opioids within 2 weeks before screening

5. Psychostimulants such as methylphenidate or dextroamphetamine within 2 weeks before screening

6. Psychotropics with antidepressant effects such as atomoxetine or thyroid supplementation, in addition to their SSRI or SNRI treatment within 2 weeks before screening

• Participant is unable to stop the following medication from the baseline visit (Visit 2) and throughout the study (tapering during screening period allowed): Any hypnotics including but not limited to: i. Benzodiazepines when used only as needed (PRN) are not allowed ii. Sedating antihistamines, including chronic use of diphenhydramine iii. Continuous use of zolpidem, zoplicon, eszopiclone and ramelteon. Note: Nonbenzodiazepines sleep aids (including: zolpidem, zaleplon, and eszopliclone) are allowed on an as needed (PRN) basis during the study but NOT within 24 hours before being in the clinic and not more than 2 nights in a row iv. S-adenosyl methionine (SAMe) v. Melatonin, agomelatine
• Has received any prior treatment with electroconvulsive therapy, vagal nerve stimulation, or a deep brain stimulation device or treatment with ketamine or esketamine for MDD

• 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

Noble Clinical Research

Tucson, Arizona, United States

Preferred Research Partners

Little Rock, Arkansas, United States

Behavioral Research Specialists LLC

Glendale, California, United States

NRC Research Institute

Orange, California, United States

Artemis Institute for Clinical Research

Riverside, California, United States

Artemis Institute for Clinical Research

San Marcos, California, United States

Pacific Clinical Research Medical Group

Upland, California, United States

Innova Clinical Trials

Miami, Florida, United States

Galiz Research

Miami Springs, Florida, United States

APG Research LLC

Orlando, Florida, United States

Olympian Clinical Research

Tampa, Florida, United States

Meridien Research

Tampa, Florida, United States

Atlanta Behavioral Research, LLC

Atlanta, Georgia, United States

Chicago Research Center

Chicago, Illinois, United States

Psychiatric Medicine Associates LLC

Skokie, Illinois, United States

Lake Charles Clinical Trials

Lake Charles, Louisiana, United States

Princeton Medical Institute

Princeton, New Jersey, United States

Integrative Clinical Trials LLC

Brooklyn, New York, United States

Richmond Behavioural Associates

Staten Island, New York, United States

Clinical Trials of America

Hickory, North Carolina, United States

Ohio State University

Columbus, Ohio, United States

Midwest Clinical Research Center

Dayton, Ohio, United States

IPS Research Company

Oklahoma City, Oklahoma, United States

Paradigm Research Professionals, LLC

Oklahoma City, Oklahoma, United States

Lehigh Center for Clinical Research

Allentown, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Clinical NeuroScience Solutions Inc

Memphis, Tennessee, United States

Advanced Clinical Research

West Jordan, Utah, United States

Emovis GmbH

Berlin, , Germany

Somni Bene GmbH

Schwerin, , Germany

ARENSIA

Chisinau, , Moldova

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

Moscow, , Russia

Orenburg Regional Clinical Psychiatric Hospital #1

Orenburg, , Russia

Medical and Rehabilitation Research Center Phoenix

Rostov-on-Don, , Russia

St-Petersburg Bekhterev Psychoneurological Research Institute

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

Research Institute of Mental Health

Tomsk, , Russia

Sverdlovsk Regional Clinical Psychiatric Hospital

Yekaterinburg, , Russia

MNCE of Kyiv RC Regional Psychiatric and Narcological Medical Association

Hlevakha, , 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

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

Kyiv, , Ukraine

Mnpe 'Regional Clinical Psychiatric Hospital of Kirovohrad Regional Council'

Nove, , Ukraine

CNCE 'Cherkasy Regional Psychiatric Hospital of Cherkasy Regional Council'

Smila, , Ukraine

MAC Clinical Research

Barnsley, , United Kingdom

MAC Clinical Research

Blackpool, , United Kingdom

MAC Clinical Research

Liverpool, , United Kingdom

Hammersmith Medicines Research Ltd

London, , United Kingdom

MAC Clinical Research

Manchester, , United Kingdom

Countries

United States; Germany; Moldova; Russia; Ukraine; United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

67953964MDD2001

Identifier Type: OTHER

Identifier Source: secondary_id

2019-000695-41

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR108487

Identifier Type: -

Identifier Source: org_study_id