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

NCT04533529 | Completed Phase 3 Results DMC FDA Drug

• 3 other identifiers: CR1088042020-000337-4042847922MDD3001
• Study Type: interventional
• Target: 588
• Locations: 11 countries
• Sites: 122

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.

Conditions

Depressive Disorder, Major

Outcome Measures

Primary Outcomes (16)

• Double Blind (DB) Treatment Phase: Change From Baseline to Day 43 in Montgomery- Asberg Depression Rating Scale (MADRS) Total Score- Estimand 1

  The MADRS is a clinician-rated scale designed to measure depression severity and detected changes due to antidepressant intervention. Scale has 10 items(apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts) each of which was scored from 0 (not present or normal) to 6 (severe or continuous presence of symptoms). MADRS total score is sum of scores from individual question items, which ranged from 0 to 60. Higher scores indicates more severe condition. Negative changes in MADRS total score indicates improvement.

  Baseline (Day 1), Day 43

• Open Label (OL) Treatment Phase: Number of Participants With Treatment Emergent Adverse Events (TEAEs)

  An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participants administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study drug. Treatment emergent AEs was defined as any AE occurred at or after the initial administration of study intervention through the day of last dose plus 2 days.

  From start of the treatment in OL phase (OL Day 1 [Day 43 from study baseline]) up to 2 days after last dose in OL phase (up to 52.28 weeks)

• OL Treatment Phase: Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESI)

  AE was defined as any untoward medical occurrence in a clinical study participants administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study drug. Treatment emergent AEs was defined as any AE occurred at or after the initial administration of study intervention through the day of last dose plus 2 days. The AEs considered to be of special interest: cataplexy, sleep paralysis, complex, sleep-related behaviors/parasomnias such as confusional arousals, somnambulism, sleep terrors, bruxism, sleep sex, sleep-related eating disorder, and catathrenia, fall, motor vehicle accident.

  From start of the treatment in OL phase (OL Day 1 [Day 43 from study baseline]) up to 2 days after last dose in OL phase (up to 52.28 weeks)

• OL Treatment Phase: Change From Baseline in Vital Signs: Blood Pressure

  Change from baseline in vital signs: systolic/diastolic blood pressure were reported. Blood pressure measurements were assessed with the participant in a sitting position using a completely automated device.

  OL Baseline (OL Day 1 [Day 43 from study baseline]) and Week 52

• OL Treatment Phase: Change From Baseline: Body Mass Index (BMI)

  Change from baseline in BMI were reported.

  OL Baseline (OL Day 1 [Day 43 from study baseline]) and Week 52

• OL Treatment Phase: Change From Baseline in Vital Signs: Temperature

  Change from baseline in vital signs: temperature were reported.

  OL Baseline (OL Day 1 [Day 43 from study baseline]) and Week 52

• OL Treatment Phase: Change From Baseline in Vital Signs: Pulse Rate

  Change from baseline in vital signs: pulse rate were reported. Pulse rate measurements were assessed with the participant in a sitting position using a completely automated device.

  OL Baseline (OL Day 1 [Day 43 from study baseline]) and Week 52

• OL Treatment Phase: Change From Baseline in Weight

  Change from baseline in weight was reported.

  OL Baseline (OL Day 1 [Day 43 from study baseline]) and Week 52

• OL Treatment Phase: Change From Baseline in Waist Circumference

  Change from baseline in waist circumference were reported.

  OL Baseline (OL Day 1 [Day 43 from study baseline]) and Week 52

• OL Treatment Phase: Number of Participants With Shift From Baseline in Suicidal Ideation and Behavior Using the Columbia Suicide Severity Rating Scale (C-SSRS)

  C-SSRS is a clinician-rated instrument that reports severity and frequency of suicide-related ideation and behaviors. Suicidal ideation was classified on a 5-item scale: 1 (wish to be dead), 2 (non-specific active suicidal thoughts), 3 (suicidal ideation without plan and intent), 4 (suicidal ideation intent to act without plan), and 5 (suicidal ideation with plan and intent), Suicidal behavior is classified on a 5-item scale: 6 (preparatory acts or behavior), 7 (aborted attempt), 8 (interrupted attempt), 9 (actual attempt), and 10 (suicide). Total score from 10 categories was summarized into 3 categories: No suicidal ideation or behavior(0), suicidal ideation (1-5), suicidal behavior (6-10). Total score ranged from 0 to 10, higher total scores indicate more suicidal ideation and/or suicidal behavior. Categories with at least 1 non-zero data values are reported.

  From DB Baseline (Day 1) up to Week 52

• OL Follow Up Phase: Physician Withdrawal Checklist (PWC-20) Total Scores at Start of OL Follow Up

  The PWC-20 was a simple and accurate method used to assess potential withdrawal symptoms following cessation of treatment. The PWC-20 was a reliable and sensitive instrument for the assessment of discontinuation symptoms. The assessment has 20 items (loss of appetite, nausea-vomiting, diarrhea, anxiety-nervousness, irritability, dysphoric mood-depression, insomnia, fatigue, poor coordination, restlessness, diaphoresis, tremor, dizziness, headaches, muscle aches or stiffness, weakness, increased acuity sound smell touch, paresthesia, difficulty concentrating-remember, depersonalization-derealization) evaluated to detect withdrawal symptoms. Symptoms are rated on a scale: 0-3, 0 =not present, 1=mild, 2 =moderate, and 3 =severe. The total PWC-20 score was the sum of 20 item scores and ranged from 0 to 60. The higher score indicates more severe symptoms.

  Start of OL Follow Up (Week 52)

• OL Follow Up Phase: Physician Withdrawal Checklist (PWC-20) Total Scores at Follow up Visit 1

  The PWC-20 was a simple and accurate method used to assess potential withdrawal symptoms following cessation of treatment. The PWC-20 was a reliable and sensitive instrument for the assessment of discontinuation symptoms. The assessment has 20 items (loss of appetite, nausea-vomiting, diarrhea, anxiety-nervousness, irritability, dysphoric mood-depression, insomnia, fatigue, poor coordination, restlessness, diaphoresis, tremor, dizziness, headaches, muscle aches or stiffness, weakness, increased acuity sound smell touch, paresthesia, difficulty concentrating-remember, depersonalization-derealization) evaluated to detect withdrawal symptoms. Symptoms are rated on a scale: 0-3, 0 =not present, 1=mild, 2 =moderate, and 3 =severe. The total PWC-20 score was the sum of 20 item scores and ranged from 0 to 60. The higher score indicates more severe symptoms.

  Follow up Visit 1: 1 day after end of OL phase (Week 52.14)

• OL Follow Up Phase: Physician Withdrawal Checklist (PWC-20) Total Scores at Follow up Visit 2

  The PWC-20 was a simple and accurate method used to assess potential withdrawal symptoms following cessation of treatment. The PWC-20 was a reliable and sensitive instrument for the assessment of discontinuation symptoms. The assessment has 20 items (loss of appetite, nausea-vomiting, diarrhea, anxiety-nervousness, irritability, dysphoric mood-depression, insomnia, fatigue, poor coordination, restlessness, diaphoresis, tremor, dizziness, headaches, muscle aches or stiffness, weakness, increased acuity sound smell touch, paresthesia, difficulty concentrating-remember, depersonalization-derealization)evaluated to detect withdrawal symptoms. Symptoms are rated on a scale: 0-3, 0 =not present, 1=mild, 2 =moderate, and 3 =severe. The total PWC-20 score was the sum of 20 item scores and ranged from 0 to 60. The higher score indicates more severe symptoms.

  Follow Up Visit 2: 2 weeks after end of OL phase (Week 54)

• OL Treatment Phase: Number of Participants With Electrocardiogram (ECG) Abnormalities

  Number of participants with ECG abnormalities during OL treatment phase was reported. ECG abnormalities were assessed as per investigator's discretion.

  Week 52

• OL Treatment Phase: Number of Participants With Clinically Significant Laboratory Abnormalities

  Laboratory parameters: hematology (platelet count, red blood cell \[RBC\] count, hemoglobin, hematocrit, neutrophils (Segmented/Leukocytes), lymphocytes, monocytes, eosinophils/leukocytes \[Eos/Leu\], basophils, Reticulocytes/ Erythrocytes \[Reti/Ery\]); chemistry (sodium, potassium, chloride, bicarbonate, creatinine, Creatine Kinase, glucose, aspartate transaminase \[AST\], alanine transaminase \[ALT\], gamma-glutamyl transferase \[GGT\], alkaline phosphatase, total bilirubin, phosphate, albumin, total protein, total cholesterol, high-density lipoprotein, low-density lipoprotein, Triglycerides); urine (specific gravity, pH, glucose, blood, bilirubin, urobilinogen, RBC). Clinically significant abnormalities (low/high) were determined at the investigator's discretion. Only those categories in which at least one participant had data were reported in this outcome measure.

  From DB Baseline (Day 1) to Week 52

• OL Treatment Phase: Number of Participants With Sexual Dysfunction as Determined by Arizona Sexual Experiences Scale (ASEX) Score

  ASEX is a five-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm. Each of the 5 items is rated on a 6-point Likert scale, ranging from 1 to 6. The 5 items are summed to create a total score, ranging from 5 to 30, with the higher scores indicating more sexual dysfunction. Sexual dysfunction is defined as an ASEX total score of 19 or greater, or a score of 5 or greater on any item, or a score of 4 or greater on any 3 items.

  Week 52

Secondary Outcomes (9)

• DB Treatment Phase: Change From Baseline to Day 43 in the MADRS Without Sleep Item (MADRS-WOSI) Total Score- Estimand 1

  Baseline (Day 1), Day 43

• DB Treatment Phase: Change From Baseline to Day 43 in Sleep Disturbance Using the Patient Reported Outcome Measurement Information System-Sleep Disturbance (PROMIS-SD) Short Form (8a) T-Score: Estimand 1

  Baseline (Day 1), Day 43

• DB Treatment Phase: Change From Baseline to Day 43 in the MADRS-6 Total Score: Estimand 1

  Baseline (Day 1), Day 43

• DB Treatment Phase: Percentage of Participants With Response on Depressive Symptoms Scale Based on MADRS at Day 43

  At Day 43

• DB Treatment Phase: Change From Baseline to Day 43 in Patient Health Questionnaire 9-item (PHQ-9) Total Score

  Baseline (Day 1), Day 43

Study Arms (2)

Seltorexant

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Participants will receive matching placebo tablet orally once daily, from Day 1 to Day 42 in double blind (DB) treatment phase.

Drug: Placebo

Interventions

Placebo DRUG

Matching placebo tablet will be administered orally once daily.

Placebo

Seltorexant DRUG

Seltorexant tablet will be administered orally once daily.

Also known as: JNJ-42847922

Seltorexant

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (122)

Advanced Research Center Inc

Anaheim, California, 92805, United States

Location

Synexus

Cerritos, California, 90703, United States

Location

Irvine Clinical Research

Irvine, California, 92614, United States

Location

Omega Clinical Trials LLC

La Habra, California, 90631, United States

Location

Synergy East

Lemon Grove, California, 91945, United States

Location

Semel Institute for Neuroscience and Human Behavior

Los Angeles, California, 90048, United States

Location

Catalina Research Institute

Montclair, California, 91763, United States

Location

Pacific Research Partners

Oakland, California, 94607, United States

Location

North County Clinical Research

Oceanside, California, 92056, United States

Location

Syrentis Clinical Research

Santa Ana, California, 92705, United States

Location

Viking Pharmaceutical Trials Inc. dba Viking Clinical Research

Temecula, California, 92591, United States

Location

Connecticut Clinical Trials LLC

Cromwell, Connecticut, 06416, United States

Location

University of Connecticut Health Center

Farmington, Connecticut, 06030, United States

Location

Sarkis Clinical Trials

Gainesville, Florida, 32607, United States

Location

Clinical NeuroScience Solutions Inc

Jacksonville, Florida, 32256, United States

Location

Pharmax Research Clinic Inc

Miami, Florida, 33126, United States

Location

Medical Research Center of Miami II Inc

Miami, Florida, 33134, United States

Location

Phoenix Medical Research, Inc.

Miami, Florida, 33165, United States

Location

Galiz Research

Miami Springs, Florida, 33166, United States

Location

Bravo Health Care Center

North Bay Village, Florida, 33141, United States

Location

APG Research LLC

Orlando, Florida, 32803, United States

Location

Combined Research Orlando

Orlando, Florida, 32803, United States

Location

Nova Psychiatry INC

Orlando, Florida, 32803, United States

Location

Revive Research Institute

Elgin, Illinois, 60123, United States

Location

Joliet Center for Clinical Research

Joliet, Illinois, 60435, United States

Location

Baber Research Group

Naperville, Illinois, 60563, United States

Location

American Medical Research, Inc.

Oak Brook, Illinois, 60523, United States

Location

Southern Illinois University School of Medicine

Springfield, Illinois, 62701, United States

Location

Louisiana Clinical Research

Shreveport, Louisiana, 71101, United States

Location

Adams Clinical

Watertown, Massachusetts, 02472, United States

Location

Neurobehavioral Medicine Group

Bloomfield Hills, Michigan, 48302, United States

Location

Midwest Research Group - St. Charles Psychiatric Associates

Saint Charles, Missouri, 63301, United States

Location

Mid-America Clinical Research, LLC

St Louis, Missouri, 63109, United States

Location

PsychCare Consultants Research

St Louis, Missouri, 63128, United States

Location

Premier Psychiatric Research Institute, LLC

Lincoln, Nebraska, 68526, United States

Location

Altea Research Institute

Las Vegas, Nevada, 89102, United States

Location

Hassman Research Institute, LLC.

Berlin, New Jersey, 08009, United States

Location

Synexus Clinical Research US Inc

Jamaica, New York, 11432, United States

Location

Bioscience Research LLC

Mount Kisco, New York, 10549, United States

Location

Haidar Almhana Nieding

Avon Lake, Ohio, 44012, United States

Location

The Ohio State University

Columbus, Ohio, 43221, United States

Location

Lindner Center of Hope

Mason, Ohio, 45040, United States

Location

Oklahoma Clinical Research Center

Oklahoma City, Oklahoma, 73112, United States

Location

Lehigh Center for Clinical Research

Allentown, Pennsylvania, 18104, United States

Location

University of Pennsylvania - Perelman School of Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

Relaro Medical Trials

Dallas, Texas, 75243, United States

Location

North Texas Clinical Trials

Fort Worth, Texas, 76104, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Red Oak Psychiatry Associates

Houston, Texas, 77090, United States

Location

Alpine Research Organization

Clinton, Utah, 84015, United States

Location

Green Mountain Research Institute

Rutland, Vermont, 05701, United States

Location

CPN - Centro de Pesquisa em Neurociências Ltda

Belo Horizonte, 30150-270, Brazil

Location

CCB Centro Cardiologico de Brasilia Ltda - CCB Cardiologia

Brasília, 70200-730, Brazil

Location

Instituto de Neurologia de Curitiba

Curitiba, 81210-310, Brazil

Location

Universidade Federal do Ceara Hospital Universitario Walter Cantidio

Fortaleza, 60430-380, Brazil

Location

Instituto Mederi de Pesquisa e Saude

Passo Fundo, 99010-120, Brazil

Location

Ruschel Medicina e Pesquisa Clínica Ltda

Rio de Janeiro, 22270 060, Brazil

Location

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

São Paulo, 04037-003, Brazil

Location

Instituto Bairral de Psiquiatria

São Paulo, 13970-905, Brazil

Location

Mental Health Center Prof. Dr. Ivan Temkov

Burgas, 8001, Bulgaria

Location

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

Cherven Bryag, 5980, Bulgaria

Location

State Psychiatric Hospital Kardzhali

Kardzhali, 6600, Bulgaria

Location

Medical center Spectar - Plovdiv EOOD

Plovdiv, 4000, Bulgaria

Location

UMHAT 'Sv. Georgi' EAD

Plovdiv, 4000, Bulgaria

Location

MHC - Sofia, EOOD

Slivnitsa, 1202, Bulgaria

Location

Medical Center St. Naum

Sofia, 1113, Bulgaria

Location

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

Sofia, 1408, Bulgaria

Location

Medical Center Intermedica, OOD

Sofia, 1680, Bulgaria

Location

Medical center - VAS OOD

Targovishte, 7700, Bulgaria

Location

Mental Health Center - Vratsa EOOD

Vratsa, 3000, Bulgaria

Location

Centro de Investigaciones y Proyectos en Neurociencias CIPNA

Barranquilla, Colombia

Location

HOMO - ESE Hospital Mental de Antioquia

Bello, 051053, Colombia

Location

Centro de Investigaciones del Sistema Nervioso Grupo Cisne Ltda.

Bogotá, 111166, Colombia

Location

Fundacion Centro de Investigacion Clinica CIC

Medellín, Colombia

Location

Psynapsis Salud Mental S.A.

Pereira, Colombia

Location

BRAIN-SOULTHERAPY s.r.o.

Kladno, 27201, Czechia

Location

Neuroterapie KH S R O

Kutná Hora, 284 01, Czechia

Location

A Shine S R O

Pilsen, 31200, Czechia

Location

Clintrial s r o

Prague, 10000, Czechia

Location

Medical Services Prague S R O

Prague, 16000, Czechia

Location

Iecsi S.C.

Monterrey, 64310, Mexico

Location

CRI Centro Regiomontano de Investigacion SC

Nuevo León, 64060, Mexico

Location

Bind Investigaciones S.C.

San Luis Potosí City, 78213, Mexico

Location

Psychoneurological Dispensary of Frunzensky District

Saint Petersburg, 190013, Russia

Location

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

Saint Petersburg, 190020, Russia

Location

City Psychiatric Hospital of St. Nikolay Chudotvorets

Saint Petersburg, 190121, Russia

Location

Bekhterev Psychoneurological Research Institute

Saint Petersburg, 192019, Russia

Location

St-Petersburg Bekhterev Psychoneurological Research Institute

Saint Petersburg, 192019, Russia

Location

Psychoneurological dispensary 1

Saint Petersburg, 199106, Russia

Location

Stavropol Region Psychiatric Hospital #2

Stavropol, 357034, Russia

Location

Yaroslavl Region Clinical Psychiatric Hospital

Yaroslavl, 150003, Russia

Location

Farmovs Pty Ltd

Bloemfontein, 9301, South Africa

Location

Iatros International

Bloemfontein, 9324, South Africa

Location

Cape Town Clinical Research Centre

Cape Town, 7530, South Africa

Location

Flexivest 14 Research

Cape Town, 7530, South Africa

Location

DJW Research

Krugersdorp, 1739, South Africa

Location

Stanza Clinical Research Centre : Mamelodi

Mamelodi East, 0122, South Africa

Location

Synexus Watermeyer

Pretoria, South Africa

Location

Somerset West Clinical Research Unit

Strand, 7140, South Africa

Location

Institucion Hosp Hestia Palau

Barcelona, 08025, Spain

Location

Hosp Univ Vall D Hebron

Barcelona, 08035, Spain

Location

Hosp. Univ. de Basurto

Bilbao, 48013, Spain

Location

Hosp. Univ. Ramon Y Cajal

Madrid, 28034, Spain

Location

Hosp. Univ. La Paz

Madrid, 28046, Spain

Location

Centro Salud Mental La Corredoria

Oviedo, 33011, Spain

Location

Clinica Univ. de Navarra

Pamplona, 31008, Spain

Location

Corporacio Sanitari Parc Tauli

Sabadell, 08208, Spain

Location

Centro de salud San Juan - IBSAL

Salamanca, 37005, Spain

Location

Hosp. Prov. de Zamora

Zamora, 49021, Spain

Location

Affecta Pskyiatrimottagning

Halmstad, SE-30248, Sweden

Location

PharmaSite Helsingborg

Helsingborg, 25220, Sweden

Location

ProbarE i Lund AB

Lund, 22222, Sweden

Location

PharmaSite

Malmö, 21152, Sweden

Location

Läkarmottagningen

Skövde, 54143, Sweden

Location

ProbarE i Solna

Stockholm, 111 37, Sweden

Location

Chang-Gung Memorial Hospital-Keelung

Keelung, 204, Taiwan

Location

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

Mackay Memorial Hospital

Taipei, 10449, Taiwan

Location

Taipei Medical University

Taipei, 110, Taiwan

Location

Cheng Hsin General Hospital

Taipei, 112, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 112, Taiwan

Location

Chang Gung Memorial Hospital- Linkou

Taoyuan County, 33305, Taiwan

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

seltorexant

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: Executive Medical Director Neuroscience
• 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 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2020
• First Posted: August 31, 2020
• Study Start: September 16, 2020
• Primary Completion: April 25, 2023
• Study Completion: April 30, 2024
• Last Updated: May 12, 2026
• Results First Posted: May 12, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

ME (3); US (51); CO (5); CZ (5); SE (6); TW (7); BU (11); BR (8); RU (8); ES (10); ZA (8)