A Study of Seltorexant as Adjunctive Therapy to Antidepressants in Adult and Elderly Participants With Major Depressive Disorder With Insomnia Symptoms Who Have Responded Inadequately to Antidepressant and Long-term Safety Extension Treatment With Seltorexant

• ClinicalTrials.gov Identifier: NCT04533529
• Recruitment Status: Recruiting
• First Posted: August 31, 2020
• Last Update Posted: March 2, 2023
• Sponsor: Janssen Research & Development, LLC
• Information provided by (Responsible Party): Janssen Research & Development, LLC

Study Description

Brief Summary:

The purpose of this study is to assess the efficacy of seltorexant compared with placebo as adjunctive therapy to an antidepressant in improving depressive symptoms in participants with major depressive disorder with insomnia symptoms (MDDIS) who have had an inadequate response to current antidepressant therapy with an selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI) in double-blind treatment phase and to assess the long-term safety and tolerability of seltorexant as adjunctive therapy to an antidepressant in participants with major depressive disorder (MDD) in open-label treatment phase.

Condition or disease	Intervention/treatment	Phase
Depressive Disorder, Major	Drug: Seltorexant; Drug: Placebo	Phase 3

Detailed Description:

Major depressive disorder (MDD) is a common, serious, recurrent disorder. Seltorexant (JNJ-42847922) is a potent and selective antagonist of the human orexin-2 receptor (OX2R) that is being developed for adjunctive treatment of major depressive disorder with insomnia symptoms (MDDIS). The hypothesis for this study is that adjunctive treatment with seltorexant is superior to placebo in treating depressive symptoms, as measured by change in Montgomery Asberg Depression Rating Scale (MADRS) total score from baseline to Day 43 in adult and elderly participants with MDDIS who have had an inadequate response to treatment with a SSRI/SNRI. The study will be conducted in 4 phases: a screening phase (up to 30 days), a double-blind (DB) treatment phase (43 days), open label (OL) treatment phase (1-year), and a post treatment follow-up phase (7 to 14 days after end of treatment). The total study duration for each participant will be up to 64 weeks. Efficacy, safety, pharmacokinetics, and biomarkers will be assessed at specified time points during this study.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 550 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of Seltorexant 20 mg as Adjunctive Therapy to Antidepressants in Adult and Elderly Patients With Major Depressive Disorder With Insomnia Symptoms Who Have Responded Inadequately to Antidepressant Therapy and an Open-labeled Long-term Safety Extension Treatment With Seltorexant
• Actual Study Start Date: September 16, 2020
• Estimated Primary Completion Date: June 6, 2023
• Estimated Study Completion Date: June 6, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Seltorexant; Participants will receive seltorexant tablet orally once daily, from Day 1 to Day 42 in double blind (DB) treatment phase. Eligible participants who will enter the open label (OL) treatment phase will receive seltorexant tablet daily from OL baseline until the end of phase/ early withdrawal (EW) visit (Up to 1 Year).	Drug: Seltorexant; Seltorexant tablet will be administered orally once daily.; Other Name: JNJ-42847922
Placebo Comparator: Placebo; Participants will receive matching placebo tablet orally once daily, from Day 1 to Day 42 in double blind (DB) treatment phase.	Drug: Placebo; Matching placebo tablet will be administered orally once daily.

Outcome Measures

Primary Outcome Measures :

1. Double-blind (DB) Treatment Phase: Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score [ Time Frame: Baseline, Day 43 ]
   MADRS is a clinician-administered scale designed to measure depression severity and detects changes due to antidepressant treatment. The MADRS evaluates the following 10 items: apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 60. Higher scores represent a more severe condition.
2. Open-Label (OL) Treatment Phase: Number of Participants with Adverse Events (AEs) including AEs of Special Interest (AESI) as a Measure of Safety and Tolerability [ Time Frame: 1 year ]
   Number of participants with AE including AE of special interest as a measure of safety and tolerability will be reported. An AE is any untoward medical occurrence in a clinical study participant administered a investigational or non-investigational medicinal product. An AE does not necessarily have a causal relationship with the treatment. AESI will comprise of cataplexy, sleep paralysis, complex, sleep-related behaviors/parasomnias, sleep terrors, bruxism, sleep sex, sleep related eating disorder, catathrenia, fall and motor vehicle accident.
3. OL Treatment Phase: Change From Baseline in Blood Pressure [ Time Frame: Baseline (Day 43), up to 1 year ]
   Change from baseline in blood pressure will be reported.
4. OL Treatment Phase: Change From Baseline in Pulse Rate [ Time Frame: Baseline (Day 43), up to 1 year ]
   Change from baseline in pulse rate will be reported.
5. OL Treatment Phase: Change From Baseline in Weight [ Time Frame: Baseline (Day 43), up to 1 year ]
   Change from baseline in weight as a part of physical examination will be reported.
6. OL Treatment Phase: Change From Baseline in Body Mass Index (BMI) [ Time Frame: Baseline (Day 43), up to 1 year ]
   Change from baseline in BMI as a part of physical examination will be reported.
7. OL Treatment Phase: Change From Baseline in Suicidality Assessment Using the Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Baseline (Day 43), up to 1 year ]
   Change from baseline in suicidality assessment using C-SSRS will be reported. C-SSRS is a clinician rated assessment of suicidal behavior and/or intent. Scale consists of 28 items in 4 sections: suicide behavior, actual attempts, suicidal ideation, and intensity of ideation. Suicidal ideation consists of 5 'yes/no' items: wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods (not plan) without intention to act, active suicidal ideation with some intent to act without specific plan, active suicidal ideation with specific plan and intent. Only items with yes responses are listed. Worsening of suicidal ideation indicates an increase in severity of suicidal ideation from baseline. Suicidal behavior consists of 5 'yes/no' items: preparatory acts or behavior, aborted attempt, actual attempt, completed suicide.
8. OL Treatment Phase: Physician Withdrawal Checklist (PWC-20) Scores [ Time Frame: End of Treatment/Early withdrawal to end of the Follow-up visit (up to 14 days) ]
   Withdrawal symptoms assessment using the PWC-20 will be reported. The PWC-20 is a simple and accurate method used to assess potential withdrawal symptoms following cessation of treatment. The PWC-20 is a reliable and sensitive instrument for the assessment of discontinuation symptoms. Each individual item score ranges from 0 (not present) to 3 (severe), where higher scores = more affected condition.
9. OL Treatment Phase: Number of Participants with Laboratory Abnormalities [ Time Frame: Up to 1 year ]
   Number of participants with laboratory abnormalities related to hematology, serum chemistry, coagulation, liver function tests and urinalysis will be reported.
10. OL Treatment Phase: Change From Baseline in QTc Interval [ Time Frame: Baseline (Day 43), up to 1 year ]
    Change from baseline in QT interval corrected for heart rate (QTc interval) using Fridericia method will be measured by electrocardiogram (ECG).
11. OL Treatment Phase: Change from Baseline in Heart Rate (HR) [ Time Frame: Baseline (Day 43), up to 1 year ]
    Change from baseline in HR will be measured by ECG.
12. OL Treatment Phase: Change from Baseline in QRS Interval [ Time Frame: Baseline (Day 43), up to 1 year ]
    Change from baseline in QRS interval will be measured by ECG.
13. OL Treatment Phase: Change from Baseline in PR Interval [ Time Frame: Baseline (Day 43), up to 1 year ]
    Change from baseline in PR interval will be measured by ECG.
14. OL Treatment Phase: Change From Baseline in QT Interval [ Time Frame: Baseline (Day 43), up to 1 year ]
    Change from baseline in QT interval will be measured by ECG.
15. OL Treatment Phase: Participant-reported Sexual Functioning Using Arizona Sexual Experiences Scale (ASEX) Score [ Time Frame: Up to 1 year ]
    The ASEX is a patient-reported 5-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm. The total scores range from 5 to 30, with the higher scores indicating more sexual dysfunction.

Secondary Outcome Measures :

1. DB Treatment Phase: Change From Baseline in the MADRS Without Sleep Item (MADRS-WOSI) Total Score [ Time Frame: Baseline and Day 43 ]
   Change from Baseline in MADRS-WOSI will be reported. MADRS-WOSI is defined as the full MADRS without the sleep item. The total score ranges from 0 to 54, with higher scores corresponding to greater symptom severity.
2. DB Treatment Phase: Change From Baseline in Sleep Disturbance Using the Patient Reported Outcome Measurement Information System-Sleep Disturbance (PROMIS-SD) Short Form 8a T-score [ Time Frame: Baseline and Day 43 ]
   The PROMIS-SD is used to assess self-reported perceptions of sleep quality, sleep depth and restoration associated with sleep. The full PROMIS-SD includes 27 items with each item based on a 7-day recall period and assessed on a 5 level Likert-type scale. The 8-item short form will be used in this study, in which responses are scored 1 to 5 for each item. A higher score on 5 of the 8 items reflects a worse outcome, whereas a higher score on 3 items reflects an improved outcome; therefore, the directionality of the 8 item scores are first synchronized prior to calculation of the total raw score. To find the total raw score for a short form with all questions answered, sum the values of the response to each question. For example, for the adult 8-item form, the lowest possible raw score is 8; the highest possible raw score is 40. Higher overall score indicates more sleep disturbance.
3. DB Treatment Phase: Change From Baseline in the MADRS-6 Total Score [ Time Frame: Baseline and Day 43 ]
   The MADRS-6 scale is a clinician-administered questionnaire used to measure the severity of MDD symptoms. The MADRS-6 scale is a subset of the MADRS-10 scale, comprises of the following individual questionnaire items: Apparent Sadness, Reported Sadness, Inner Tension, Lassitude, Inability to Feel, and Pessimistic Thoughts. Scores range from 0 (no apparent symptoms) to 36 (most severe symptoms).
4. DB Treatment Phase: Percentage of Participants with Response on Depressive Symptoms Scale Based on Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: Day 43 ]
   Percentage of participants with response on depressive symptoms scale based on MADRS will be reported. Responders are defined as percentage of participants with greater than or equal to (>=) 50 percent (%) improvement in the MADRS total score from baseline to Day 43.
5. DB Treatment Phase: Change From Baseline in Patient Health Questionnaire, 9-Item (PHQ-9) Total Score [ Time Frame: Baseline and Day 43 ]
   The PHQ-9 is a 9-item, participant reported outcome 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 participant's item responses are summed to provide a total score (range of 0 to 27), with higher scores indicating greater severity of depressive symptoms.
6. DB Treatment Phase: Number of Participants with Adverse Events (AEs) including AEs of Special Interest (AESI) as a Measure of Safety and Tolerability [ Time Frame: Up to Day 50 to 57 (every two weeks) ]
   Number of participants with AE including AE of special interest as a measure of safety and tolerability will be reported. An AE is any untoward medical occurrence in a clinical study participant administered a investigational or non-investigational medicinal product. An AE does not necessarily have a causal relationship with the treatment. AESI include: Cataplexy, Sleep paralysis, complex, sleep-related behaviors/parasomnias such as: confusional arousal, somnambulism, sleep terror, bruxism, sleep sex, sleep-related eating disorder, sleep behavior disorder, catathrenia.
7. OL Treatment Phase: Change From Baseline Over Time in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score [ Time Frame: Baseline (Day 43), up to 1 year ]
   MADRS is a clinician-administered scale designed to measure depression severity and detects changes due to antidepressant treatment. The MADRS evaluates the following 10 items: apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 60. Higher scores represent a more severe condition.
8. OL Treatment Phase: Change From Baseline Over Time in the Clinical Global Impression-Severity (CGI S) Score [ Time Frame: Baseline (Day 43), up to 1 year ]
   The CGI-S is a 7-point global assessment scale that measures the clinician's impression of the severity of illness exhibited by a participant, rating according to: 1=normal (not at all ill); 2=borderline ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; and 7=among the most extremely ill participants. Higher scores indicate worsening.
9. OL Treatment Phase: Change from Baseline Over Time in the MADRS-WOSI Total Score [ Time Frame: Baseline (of OL phase), up to 1 year ]
   Change from Baseline in MADRS-WOSI will be reported. MADRS-WOSI is defined as the full MADRS without the sleep item. The total score ranges from 0 to 54, with higher scores corresponding to greater symptom severity.
10. OL Treatment Phase: Change From Baseline Over Time in Sleep Disturbance Using the PROMIS SD Short Form 8a T-score [ Time Frame: Baseline (Day 43), up to Year 1 ]
    The PROMIS-Sleep Disturbance (PROMIS-SD) is used to assess self-reported perceptions of sleep quality, sleep depth and restoration associated with sleep. The full PROMIS-SD includes 27 items with each item based on a 7-day recall period and assessed on a 5 level Likert-type scale. The 8-item short form will be used in this study, in which responses are scored 1 to 5 for each item. A higher score on 5 of the 8 items reflects a worse outcome, whereas a higher score on 3 items reflects an improved outcome; therefore, the directionality of the 8 item scores are first synchronized prior to calculation of the total raw score. To find the total raw score for a short form with all questions answered, sum the values of the response to each question. For example, for the adult 8-item form, the lowest possible raw score is 8; the highest possible raw score is 40. Higher overall score indicates more sleep disturbance.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 74 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Meet Diagnostic and Statistical Manual of Mental Disorders-5th edition (DSM-5) diagnostic criteria for major depressive disorder (MDD), without psychotic features, based upon clinical assessment and confirmed by the Structured Clinical Interview for DSM-5 Axis I Disorders-Clinical Trials Version (SCID-CT) diagnosed with first depressive episode prior to age 60. The length of the current depressive episode must be less than or equal to (<=) 24 months prior to randomization
• Have had an inadequate response to at least 1 but no more than 2 antidepressants, administered at an adequate dose and duration in the current episode of depression. The current antidepressant cannot be the first antidepressant treatment for the first lifetime episode of depression. An inadequate response is defined as less than (<) 50 percent (%) reduction but with some improvement (that is, improvement greater than [>] 0%) in depressive symptom severity with residual symptoms beyond insomnia present, and overall good tolerability, as assessed by the Massachusetts General Hospital-Antidepressant Treatment Response Questionnaire (MGH-ATRQ)
• Is receiving and tolerating well any one of the following selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI) for depressive symptoms at screening, in any formulation and available in the participating country: citalopram, duloxetine, escitalopram, fluvoxamine, fluoxetine, milnacipran, levomilnacipran, paroxetine, sertraline, venlafaxine, desvenlafaxine, vilazodone, or vortioxetine at a stable dose (at therapeutic dose level) for at least 6 weeks, and for no greater than 18 months in the current episode
• Body mass index (BMI) between 18 and 40 kilograms per meter square (kg/m^2), inclusive (BMI = weight/height^2)
• Participant must be medically stable on the basis of the following performed at screening: physical examination (including a brief neurological examination), vital signs (including blood pressure), and 12-lead electrocardiogram (ECG) performed at screening and baseline

Exclusion Criteria:

• Has a recent (last 3 months) history of, or current signs and symptoms of, a) severe renal insufficiency (creatinine clearance [CrCl] <30 milliliter per minute [mL/min]); b) clinically significant or unstable cardiovascular, respiratory, gastrointestinal, neurologic, hematologic, rheumatologic, immunologic or endocrine disorders; c) uncontrolled Type 1 or Type 2 diabetes mellitus
• Has a current or recent history of homicidal ideation or serious suicidal ideation within the past 3 months, corresponding to a positive response on item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) for ideation on the Columbia Suicide Severity Rating Scale (C-SSRS), or a history of suicidal behavior within the past 6 months, as validated by the C-SSRS at screening or Day 1. Participants with prior suicidal behavior in the past year, or prior serious suicidal ideation/plan within the past 6 months, should be carefully screened. For current suicidal ideation, only participants with non serious items (1-3 of the suicidal ideation section of the C-SSRS) may be included at the discretion of the investigator
• Has a history of treatment-resistant MDD, defined as a lack of response to 2 or more adequate antidepressant treatments in the current episode, as indicated by no or minimal (<25% improvement in symptoms) when treated with an antidepressant of adequate dose (per MGH-ATRQ) and duration (at least 6 weeks)
• Has history or current diagnosis of a psychotic disorder, bipolar disorder, intellectual disability, autism spectrum disorder, borderline personality disorder, or somatoform disorders
• Has any significant primary sleep disorder, including but not limited to obstructive sleep apnea, restless leg syndrome, or parasomnias. Participants with insomnia disorder are allowed
• Has a history of moderate to severe substance use disorder including alcohol use disorder according to DSM-5 criteria within 6 months before screening

Contacts and Locations

Contacts

Contact: Study Contact; 844-434-4210; Participate-In-This-Study@its.jnj.com

Locations

United States, Arizona

NoesisPharma Research; Withdrawn

Phoenix, Arizona, United States, 85016

United States, California

Advanced Research Center Inc; Recruiting

Anaheim, California, United States, 92805

Synexus; Recruiting

Cerritos, California, United States, 90703

Irvine Clinical Research; Recruiting

Irvine, California, United States, 92614

Omega Clinical Trials LLC; Recruiting

La Habra, California, United States, 90631

Synergy East; Recruiting

Lemon Grove, California, United States, 91945

Semel Institute for Neuroscience and Human Behavior; Recruiting

Los Angeles, California, United States, 90048

Catalina Research Institute; Completed

Montclair, California, United States, 91763

Pacific Research Partners; Completed

Oakland, California, United States, 94607

North County Clinical Research; Recruiting

Oceanside, California, United States, 92056

Syrentis Clinical Research; Recruiting

Santa Ana, California, United States, 92705

Viking Pharmaceutical Trials Inc. dba Viking Clinical Research; Recruiting

Temecula, California, United States, 92591

United States, Connecticut

Connecticut Clinical Trials, LLC; Recruiting

Cromwell, Connecticut, United States, 06416

University of Connecticut Health Center; Recruiting

Farmington, Connecticut, United States, 06030

United States, Florida

Sarkis Clinical Trials; Recruiting

Gainesville, Florida, United States, 32607

Clinical NeuroScience Solutions, Inc; Recruiting

Jacksonville, Florida, United States, 32256

Galiz Research; Recruiting

Miami Springs, Florida, United States, 33166

Pharmax Research Clinic Inc; Recruiting

Miami, Florida, United States, 33126

Medical Research Center of Miami II Inc; Suspended

Miami, Florida, United States, 33134

Phoenix Medical Research, Inc.; Recruiting

Miami, Florida, United States, 33165

Bravo Health Care Center; Recruiting

North Bay Village, Florida, United States, 33141

APG Research, LLC; Recruiting

Orlando, Florida, United States, 32803

Combined Research Orlando; Recruiting

Orlando, Florida, United States, 32803

Nova Psychiatry, INC; Recruiting

Orlando, Florida, United States, 32803

United States, Illinois

Northwestern University Feinberg School of Medicine; Withdrawn

Chicago, Illinois, United States, 60611

Revive Research Institute; Recruiting

Elgin, Illinois, United States, 60123

Joliet Center for Clinical Research; Completed

Joliet, Illinois, United States, 60435

Baber Research Group; Recruiting

Naperville, Illinois, United States, 60563

American Medical Research, Inc.; Completed

Oak Brook, Illinois, United States, 60523

Southern Illinois University School of Medicine; Recruiting

Springfield, Illinois, United States, 62701

United States, Louisiana

Louisiana Clinical Research; Recruiting

Shreveport, Louisiana, United States, 71101

United States, Massachusetts

Adams Clinical; Recruiting

Watertown, Massachusetts, United States, 02472

United States, Michigan

Neurobehavioral Medicine Group; Recruiting

Bloomfield Hills, Michigan, United States, 48302

United States, Missouri

Midwest Research Group - St. Charles Psychiatric Associates; Recruiting

Saint Charles, Missouri, United States, 63301

Mid-America Clinical Research, LLC; Completed

Saint Louis, Missouri, United States, 63109

PsychCare Consultants Research; Recruiting

Saint Louis, Missouri, United States, 63128

United States, Nebraska

Premier Psychiatric Research Institute, LLC; Completed

Lincoln, Nebraska, United States, 68526

United States, Nevada

Altea Research Institute; Completed

Las Vegas, Nevada, United States, 89102

United States, New Jersey

Hassman Research Institute, LLC.; Completed

Berlin, New Jersey, United States, 08009

United States, New York

University of Buffalo; Withdrawn

Buffalo, New York, United States, 14215

Synexus Clinical Research US, Inc; Completed

Jamaica, New York, United States, 11432

Bioscience Research LLC; Recruiting

Mount Kisco, New York, United States, 10549

United States, Ohio

Haidar Almhana Nieding; Recruiting

Avon Lake, Ohio, United States, 44012

The Cleveland Clinic Foundation; Withdrawn

Cleveland, Ohio, United States, 44195

The Ohio State University; Recruiting

Columbus, Ohio, United States, 43221

Lindner Center of Hope; Completed

Mason, Ohio, United States, 45040

United States, Oklahoma

University of Oklahoma Health Sciences Center; Withdrawn

Oklahoma City, Oklahoma, United States, 73104

Oklahoma Clinical Research Center; Recruiting

Oklahoma City, Oklahoma, United States, 73112

United States, Oregon

Oregon Center for Clinical Investigations, Inc.; Withdrawn

Salem, Oregon, United States, 97301

United States, Pennsylvania

Lehigh Center for Clinical Research; Recruiting

Allentown, Pennsylvania, United States, 18104

University of Pennsylvania - Perelman School of Medicine; Recruiting

Philadelphia, Pennsylvania, United States, 19104

United States, South Dakota

Concordia Mind Health; Withdrawn

Sioux Falls, South Dakota, United States, 57108

United States, Texas

Relaro Medical Trials; Recruiting

Dallas, Texas, United States, 75243

North Texas Clinical Trials; Recruiting

Fort Worth, Texas, United States, 76104

Baylor College of Medicine; Recruiting

Houston, Texas, United States, 77030

Red Oak Psychiatry Associates; Completed

Houston, Texas, United States, 77090

United States, Utah

Alpine Research Organization; Recruiting

Clinton, Utah, United States, 84015

United States, Vermont

Green Mountain Research Institute; Recruiting

Rutland, Vermont, United States, 05701

Brazil

CPN - Centro de Pesquisa em Neurociências Ltda; Recruiting

Belo Horizonte, Brazil, 30150-270

CCB Centro Cardiologico de Brasilia Ltda - CCB Cardiologia; Recruiting

Brasilia, Brazil, 70200-730

Instituto de Neurologia de Curitiba; Recruiting

Curitiba, Brazil, 81210-310

Universidade Federal do Ceara - Hospital Universitario Walter Cantidio; Recruiting

Fortaleza, Brazil, 60430-380

Instituto Mederi de Pesquisa e Saude; Recruiting

Passo Fundo, Brazil, 99010-120

Ruschel Medicina e Pesquisa Clínica Ltda; Recruiting

Rio de Janeiro, Brazil, 22270-060

Universidade Federal da Bahia - Hospital Professor Edgard Santos; Withdrawn

Salvador, Brazil, 40110-060

SPDM - Associacao Paulista para o Desenvolvimento da Medicina - Hospital Sao Paulo; Recruiting

Sao Paulo, Brazil, 04037-003

Instituto Bairral de Psiquiatria; Recruiting

Sao Paulo, Brazil, 13970-905

Bulgaria

Mental Health Center Prof. Dr. Ivan Temkov; Recruiting

Bourgas, Bulgaria, 8001

Ambulatory for Individual Practice for Specialized Medical Care in Psychiatry Dr. Ivo Natsov ET; Recruiting

Cherven bryag, Bulgaria, 5980

State Psychiatric Hospital Kardzhali; Recruiting

Kardzhali, Bulgaria, 6600

State Psychiatric Hospital Pazardzhik; Withdrawn

Pazardzhik, Bulgaria, 4400

Medical center Spectar - Plovdiv EOOD; Recruiting

Plovdiv, Bulgaria, 4000

UMHAT 'Sv. Georgi' EAD; Recruiting

Plovdiv, Bulgaria, 4000

MHC - Sofia, EOOD; Recruiting

Slivnitsa, Bulgaria, 1202

Medical Center St. Naum; Recruiting

Sofia, Bulgaria, 1113

DCC 'Sv. Vrach and Sv. Sv. Kuzma and Damyan', OOD; Recruiting

Sofia, Bulgaria, 1408

Medical Center Intermedica, OOD; Recruiting

Sofia, Bulgaria, 1680

Medical center - VAS OOD; Completed

Targovishte, Bulgaria, 7700

Mental Health Center - Vratsa EOOD; Recruiting

Vratsa, Bulgaria, 3000

Colombia

Centro de Investigaciones y Proyectos en Neurociencias CIPNA; Recruiting

Barranquilla, Colombia

HOMO - ESE Hospital Mental de Antioquia; Recruiting

Bello, Colombia, 051053

Solano y Terront Servicios Médicos Ltda.; Withdrawn

Bogota, Colombia, 110221

Centro de Investigaciones del Sistema Nervioso Grupo Cisne Ltda.; Recruiting

Bogotá, Colombia, 111166

Fundacion Centro de Investigacion Clinica CIC; Recruiting

Medellin, Colombia

Psynapsis Salud Mental S.A.; Recruiting

Pereira, Colombia

Czechia

BRAIN-SOULTHERAPY s.r.o.; Recruiting

Kladno, Czechia, 27201

Neuroterapie KH, s.r.o.; Recruiting

Kutna Hora, Czechia, 284 01

A-Shine s.r.o.; Recruiting

Plzen, Czechia, 31200

Clintrial s.r.o.; Recruiting

Praha 10, Czechia, 10000

Medical Services Prague s.r.o.; Recruiting

Praha 6, Czechia, 16000

Mexico

Clinica Cemelli; Withdrawn

Guadalajara, Mexico, 44200

Health Pharma Professional Research; Withdrawn

Mexico, Mexico, 3810

Centro de Investigación Clínica Acelerada, SC; Withdrawn

Mexico, Mexico, 7020

Iecsi S.C.; Recruiting

Monterrey, Mexico, 64310

cit NEUROPSIQUE; Withdrawn

Monterrey, Mexico, 64610

CRI Centro Regiomontano de Investigacion SC; Recruiting

Nuevo Leon, Mexico, 64060

Bind Investigaciones S.C.; Recruiting

San Luis Potosi, Mexico, 78213

Fundacion Santos Y De La Garza Evia IBP; Withdrawn

San Pedro Garza Garcia, Mexico, 66278

Russian Federation

LLC City Neurological Center-Sibneuromed; Withdrawn

Novosibirsk, Russian Federation, 630091

Psychoneurological dispensary 1; Recruiting

Saint Petersburg, Russian Federation, 199106

City Psychiatric Hospital of St. Nikolay Chudotvorets; Recruiting

Saint-Petersburg, Russian Federation, 190121

Bekhterev Psychoneurological Research Institute; Recruiting

St Petersburg, Russian Federation, 192019

Psychoneurological Dispensary of Frunzensky District; Recruiting

St-Petersburg, Russian Federation, 190013

SPb SBIH 'City Psychoneurological Dispensary # 7 (With Inpatient Facilities)'; Recruiting

St. Petersburg, Russian Federation, 190020

St-Petersburg Bekhterev Psychoneurological Research Institute; Completed

St. Petersburg, Russian Federation, 192019

Stavropol Region Psychiatric Hospital #2; Recruiting

Stavropol, Russian Federation, 357034

Yaroslavl Region Clinical Psychiatric Hospital; Recruiting

Yaroslavl, Russian Federation, 150003

South Africa

Farmovs Pty Ltd; Recruiting

Bloemfontein, South Africa, 9301

Iatros International; Recruiting

Bloemfontein, South Africa, 9324

Cape Town Clinical Research Centre; Recruiting

Cape Town, South Africa, 7530

Flexivest 14 Research; Recruiting

Cape Town, South Africa, 7530

David Dennis - Western Cape South Africa; Withdrawn

Cape Town, South Africa, 7708

DJW Research; Completed

Krugersdorp, South Africa, 1739

Stanza Clinical Research Centre : Mamelodi; Completed

Mamelodi East, South Africa, 0122

Synexus Watermeyer; Recruiting

Pretoria, South Africa

Somerset West Clinical Research Unit; Recruiting

Strand, South Africa, 7140

Spain

Institucion Hosp Hestia Palau; Recruiting

Barcelona, Spain, 08025

Hosp. Univ. Vall D Hebron; Recruiting

Barcelona, Spain, 08035

Hosp. Univ. de Basurto; Completed

Bilbao, Spain, 48013

Hosp. Valle Del Nalon; Withdrawn

Langreo, Spain, 33920

Hosp. Univ. Ramon Y Cajal; Recruiting

Madrid, Spain, 28034

Hosp. Univ. La Paz; Recruiting

Madrid, Spain, 28046

Centro Salud Mental La Corredoria; Recruiting

Oviedo, Spain, 33011

Clinica Univ. De Navarra; Recruiting

Pamplona, Spain, 31008

Corporacio Sanitari Parc Tauli; Recruiting

Sabadell, Spain, 08208

Centro de salud San Juan - IBSAL; Recruiting

Salamanca, Spain, 37005

Hosp. Prov. de Zamora; Recruiting

Zamora, Spain, 49021

Sweden

Sahlgrenska University Hospital; Withdrawn

Goteborg, Sweden, 413 45

Affecta Pskyiatrimottagning; Completed

Halmstad, Sweden, SE-30248

PharmaSite Helsingborg; Completed

Helsingborg, Sweden, 25220

ProbarE i Lund AB; Recruiting

Lund, Sweden, 22222

PharmaSite; Completed

Malmo, Sweden, 21152

Läkarmottagningen; Recruiting

Skovde, Sweden, 54143

ProbarE i Solna; Recruiting

Stockholm, Sweden, 111 37

Sophiahemmet; Withdrawn

Stockholm, Sweden, 11486

Taiwan

Chang-Gung Memorial Hospital-Keelung; Recruiting

Keelung, Taiwan, 204

Taipei Medical University; Recruiting

Taipei City, Taiwan, 110

National Taiwan University Hospital; Recruiting

Taipei, Taiwan, 10002

Mackay Memorial Hospital; Recruiting

Taipei, Taiwan, 10449

Cheng Hsin General Hospital; Recruiting

Taipei, Taiwan, 112

Taipei Veterans General Hospital; Recruiting

Taipei, Taiwan, 112

Chang Gung Memorial Hospital- Linkou; Recruiting

Taoyuan County, Taiwan, 33305

Sponsors and Collaborators

Janssen Research & Development, LLC

Investigators

• Study Director: Janssen Research & Development, LLC Clinical Trial; Janssen Research & Development, LLC

More Information

• Responsible Party: Janssen Research & Development, LLC
• ClinicalTrials.gov Identifier: NCT04533529
• Other Study ID Numbers: CR108804; 2020-000337-40 ( EudraCT Number ); 42847922MDD3001 ( Other Identifier: Janssen Research & Development, LLC )
• First Posted: August 31, 2020
• Last Update Posted: March 2, 2023
• Last Verified: March 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: 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
• URL: https://www.janssen.com/clinical-trials/transparency

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:

Depressive Disorder; Depression; Depressive Disorder, Major; Mood Disorders; Mental Disorders; Behavioral Symptoms