Phase 3 Study of Adjunctive Treatment With Seltorexant in Adult and Elderly Participants With Major Depressive Disorder and Insomnia Symptoms

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified April 2026 by Janssen Research & Development, LLC
Sponsor
Janssen Research & Development, LLC
Information Provided by (Responsible Party)
Janssen Research & Development, LLC
Clinicaltrials.gov Identifier
NCT06559306
Other Study ID Numbers:
42847922MDD3003
First Submitted
August 14, 2024
First Posted
August 18, 2024
Last Update Posted
May 7, 2026
Last Verified
April 2026

ClinicalTrials.gov processed this data on May 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Depressive Disorder, Major
Drug: SeltorexantDrug: PlaceboDrug: SeltorexantDrug: SeltorexantDrug: Placebo

Study Design

Study TypeInterventional
Actual Enrollment752 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingDouble
Primary PurposeTreatment
Official TitleA Two-Part Multicenter, Double-Blind, Randomized Placebo-Controlled Study to Evaluate Efficacy and Safety and the Maintenance of Effect of 20-(Milligram) mg Seltorexant as Adjunctive Therapy to Antidepressants in Adult and Elderly Patients With Major Depressive Disorder With Insomnia Symptoms
Study Start DateJuly 24, 2024
Actual Primary Completion Date7mos 3w from now
Actual Study Completion Date7mos 3w from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Part 1: Seltorexant
Participants will receive seltorexant orally once daily for 6 weeks during the double-blind (DB) treatment phase in Part 1 of the study. Participants who do not proceed to Part 2 of the study will undergo a post-treatment follow-up phase, after the DB treatment phase in Part 1 and will continue to take their single baseline selective serotonin reuptake inhibitor (SSRI)/serotonin-norepinephrine reuptake inhibitor (SNRI) antidepressant throughout the study.
Drug: Seltorexant
Seltorexant will be administered orally.
Part 1: Placebo
Participants will receive matching placebo orally once daily for 6 weeks during the DB treatment phase in Part 1 of the study. Participants who do not proceed to Part 2 of the study will undergo a post-treatment follow-up phase, after the DB treatment phase in Part 1 and will continue to take their single baseline SSRI/SNRI antidepressant throughout the study.
Drug: Placebo
Matching Placebo tablets will be administered orally.
Part 2: Open Label (OL) Seltorexant
All participants who complete Part 1, and who meet eligibility criteria for Part 2, as well as direct entry participants, will enter Part 2 of the study. In Part 2 open-label phases (induction and stabilization) all participants (newly enrolled direct entry participants and Part 1 roll-over participants) will receive seltorexant orally in addition to their background SSRI/SNRI treatment.
Drug: Seltorexant
Seltorexant will be administered orally.
Part 2: DB Seltorexant
All participants who complete Part 1, and who meet eligibility criteria for Part 2, as well as direct entry participants, will enter Part 2 of the study. Participants who achieve a stable response during the open-label phase will receive treatment with seltorexant orally once daily during DB Maintenance Phase in Part 2 of the study. Participants will continue to take their single baseline SSRI/SNRI antidepressant throughout the study.
Drug: Seltorexant
Seltorexant will be administered orally.
Part 2: DB Placebo
All participants who complete Part 1, and who meet eligibility criteria for Part 2, as well as direct entry participants, will enter Part 2 of the study. Participants who achieve a stable response during the open-label phases will receive treatment with matching placebo orally once daily during DB Maintenance Phase in Part 2 of the study. Participants will continue to take their single baseline SSRI/SNRI antidepressant throughout the study.
Drug: Placebo
Matching Placebo tablets will be administered orally.

Outcome Measures

Primary Outcome Measures
  1. Part 1: Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Day 43
    The MADRS is a clinician-administered 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), for a total possible score of 60. Higher scores represent a more severe condition.
  2. Part 2: Time from Randomization to the First Relapse in Participants Who Achieve a Stable Response
    Stable response is defined as a greater than equal to (\>=) 50 percent (%) reduction in the MADRS total score for the last 3 consecutive visits of the OL stabilization Phase, as assessed by the site investigator. Time from randomization to the first relapse during the DB maintenance phase in participants who achieve a stable response at the end of OL seltorexant treatment will be reported.
Secondary Outcome Measures
  1. Part 1: Change from Baseline in the MADRS Without Sleep Item (MADRS-WOSI) Total Score at Day 43
    MADRS-WOSI considered 9 of the 10 MADRS items, excluding "reduced sleep" item. The total score ranged from 0 to 54, with higher scores corresponding to greater symptom severity.
  2. Part 1: Change from Baseline in Sleep Disturbance Using the Patient Reported Outcome Measurement Information System-Sleep Disturbance (PROMIS-SD) Short Form 8a T-score at 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. T-score for the PROMIS-SD scales represent the value obtained after using a conversion table to convert 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. Part 1: Change from Baseline in the MADRS-6 Total Score at Day 43
    The MADRS-6 scale is a clinician-administered questionnaire used to measure the severity of major depressive disorder (MDD) symptoms. The MADRS-6 scale is a subset of the MADRS -10 scale, comprised 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. Part 1: Percentage of Participants with Response on Depressive Symptoms Scale Based on Montgomery-Asberg Depression Rating Scale (MADRS) Total score From Baseline to Day 43
    Responders are defined as participants with \>= 50 percent improvement in the MADRS total score from baseline to Day 43.
  5. Part 1: Change from Baseline in Sleep Disturbance Using the Patient Reported Outcome Measurement Information System-Sleep Disturbance (PROMIS-SD) Short Form (4a) T-score at 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 4-item short form will be used in this study, in which responses are scored 1 to 5 for each item. T-score for the PROMIS-SD scales represent the value obtained after using a conversion table to convert 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 4-item form, the lowest possible raw score is 4; the highest possible raw score is 20. Higher overall score indicates more sleep disturbance.
  6. Part 1: Change from Baseline in Sleep Disturbance Using the Patient Reported Outcome Measurement Information System-Sleep Disturbance (PROMIS-SD) Short Form (10a) T-score at 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 10-item short form will be used, in which responses are scored 1 to 5 for each item. T-score for the PROMIS-SD scales represent the value obtained after using a conversion table to convert 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 10-item form, the lowest possible raw score is 10; the highest possible raw score is 50. Higher overall score indicates more sleep disturbance.
  7. Part 1: Change from Baseline in Patient Health Questionnaire, 9-Item (PHQ-9) Total Score at 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.
  8. Part 2: Time from Randomization to the First Relapse in Participants Who Achieve a Stable Remission
    Stable remission is defined as MADRS total score less than or equal to (\<=)10 and CGI-S \<= 2 for at least 4 consecutive weeks of the OL stabilization Phase. Time from randomization to the first relapse during the DB maintenance phase in participants who achieve stable remission at the end of the OL seltorexant treatment will be reported.
  9. Part 2: Change from Baseline to Endpoint of the DB Maintenance Phase in Sleep Disturbance Using the PROMIS-SD Short Form (8a) T-Score
    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. T-score for the PROMIS-SD scales represent the value obtained after using a conversion table to convert 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.
  10. Part 2: Change from Baseline to Endpoint of the DB Maintenance Phase in Sleep Disturbance Using the PROMIS-SD Short Form (4a) T-Score
    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 4-item short form will be used in this study, in which responses are scored 1 to 5 for each item. T-score for the PROMIS-SD scales represent the value obtained after using a conversion table to convert 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 4-item form, the lowest possible raw score is 4; the highest possible raw score is 20. Higher overall score indicates more sleep disturbance.
  11. Part 2: Change from Baseline in Sleep Disturbance Using the Patient Reported Outcome Measurement Information System-Sleep Disturbance (PROMIS-SD) Short Form (10a) T-score at 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 10-item short form will be used, in which responses are scored 1 to 5 for each item. T-score for the PROMIS-SD scales represent the value obtained after using a conversion table to convert 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 10-item form, the lowest possible raw score is 10; the highest possible raw score is 50. Higher overall score indicates more sleep disturbance.
  12. Part 2: Change from Baseline to Endpoint of the DB Maintenance Phase in MADRS Total Score
    The MADRS is a clinician-administered 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), for a total possible score of 60. Higher scores represent a more severe condition.
  13. Part 2: Change from Baseline to Endpoint of DB Maintenance Phase in PHQ-9 Score
    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 DSM-5 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.
  14. Change From Baseline to Endpoint of the DB Maintenance Phase in the MADRS-6 score
    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, comprised 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).
  15. Change from Baseline to Endpoint of the DB Maintenance Phase in the MADRS symptoms other than insomnia MADRS Without Sleep Item (MADRS-WOSI)
    MADRS-WOSI considered 9 of the 10 MADRS items, excluding "reduced sleep" item. The total score ranged from 0 to 54, with higher scores corresponding to greater symptom severity.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion Criteria
Participants in part 1 and direct enrollers to part 2:
Meet DSM-5 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
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. An inadequate response is defined as less than (\<) 50% reduction but with some improvement (that is, improvement greater than \[\>\] 0%) in depressive symptom severity with residual symptoms other than insomnia present, and overall good tolerability, as assessed by the MGH-ATRQ, and this must include the participant's current antidepressant treatment
Is receiving and tolerating well any one of the following SSRI or 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
Having a major depressive episode of at least moderate severity, as assessed with 17-item Hamilton Depression Rating Scale, implemented through the Structured Interview Guide (SIGH-D) in a blinded manner at screening and must not demonstrate a clinically significant improvement from the beginning to end of screening. Participants entering after completing part 1:
Must have completed Part 1 DB treatment phase
Can consistently tolerate study drug (at the end of Part 1), and there is no additional safety risk for the participant if they proceed to Part 2
Was able to consistently follow the study procedures in Part 1 as judged by the investigator.
Must be medically stable based on clinical laboratory tests
Exclusion Criteria
Has a recent (last 3 months) history of, or current signs and symptoms of, severe renal insufficiency clinically significant or unstable cardiovascular, respiratory, gastrointestinal, neurologic, hematologic, rheumatologic, immunologic or endocrine disorders and uncontrolled Type 1 or Type 2 diabetes mellitus
Has a history of narcolepsy and seizures
Has current signs/symptoms of hypothyroidism or hyperthyroidism
Participants taking thyroid supplementation for antidepressant purposes
Has Cushing's disease, Addison's disease, primary amenorrhea, or other evidence of significant medical disorders of the HPA axis

Contacts and Locations

Sponsors and CollaboratorsJanssen Research & Development, LLC
Locations
University of Alabama at Birmingham | Birmingham Alabama, United States, 35294Chandler Clinical Trials | Chandler Arizona, United States, 85224University of Arizona | Tucson Arizona, United States, 85724SanRo Clinical Research Group LLC WCG Clinical Network | Bryant Arkansas, United States, 72022Preferred Research Partners | Little Rock Arkansas, United States, 72211PAMOJA Clinical Institute LLC | Anaheim California, United States, 92801Axiom Research | Colton California, United States, 92324Elite Research Network 6 | Encino California, United States, 91316Behavioral Research Specialists LLC | Glendale California, United States, 91206WR PRI Los Alamitos | Los Alamitos California, United States, 90720Excell Research Inc | Oceanside California, United States, 92056Prospective Research Innovations Inc | Rancho Cucamonga California, United States, 91730Anderson Clinical Research | Redlands California, United States, 92374Lumos Clinical Research Center LLC | San Jose California, United States, 95124Syrentis Clinical Research | Santa Ana California, United States, 92705California Neuroscience Research | Sherman Oaks California, United States, 91403Mountain View Clinical Research | Denver Colorado, United States, 80209UConn Health Center | Farmington Connecticut, United States, 06030Clinical Research of Brandon | Brandon Florida, United States, 33511AGA Clinical Trials | Hialeah Florida, United States, 33012Reliable Clinical Research | Hialeah Florida, United States, 33012Advanced Research Institute of Miami | Homestead Florida, United States, 33033Clinical NeuroScience Solutions Inc | Jacksonville Florida, United States, 32256Multi Specialty Research Associates Inc | Lake City Florida, United States, 32055Alcanza Clinical Research | Largo Florida, United States, 33777Pharmax Research Clinic Inc | Miami Florida, United States, 33126Miami Dade Medical Research Institute | Miami Florida, United States, 33176Nuovida Research Center | Miami Florida, United States, 33186Aqualane Clinical Research | Naples Florida, United States, 34105Bravo Health Care Center | North Bay Village Florida, United States, 33141Nova Psychiatry INC | Orlando Florida, United States, 32803Florida Center for TMS | Saint Augustine Florida, United States, 32086University of South Florida | Tampa Florida, United States, 33613Psych Me Medical Research Inc | Tampa Florida, United States, 33614Interventional Psychiatry of Tampa Bay | Tampa Florida, United States, 33629Health Synergy Clinical Research | West Palm Beach Florida, United States, 33407Conquest Research | Winter Park Florida, United States, 32789Advanced Discovery Research | Atlanta Georgia, United States, 30318Agile Clinical Research Trials, LLC | Atlanta Georgia, United States, 30328iResearch Atlanta LLC | Decatur Georgia, United States, 30030Peachford Hospital-Atlanta Behavorial Research | Dunwoody Georgia, United States, 30338iResearch Savannah | Savannah Georgia, United States, 31405Accelerated Clinical Research Group LLC | Snellville Georgia, United States, 30078Renew Health Clinical Research | Snellville Georgia, United States, 30078Northwestern University | Chicago Illinois, United States, 60611MetroMed Clinical Research | Chicago Illinois, United States, 60614University of Chicago Medical Center | Chicago Illinois, United States, 60637Revive Research Institute | Elgin Illinois, United States, 60123Baber Research Group | Naperville Illinois, United States, 60563Boston Clinical Trials | Boston Massachusetts, United States, 02131Adams Clinical LLC | Watertown Massachusetts, United States, 02472Mankato Clinic | Mankato Minnesota, United States, 56001Redbird Research | Las Vegas Nevada, United States, 89119Oasis Clinical Research LLC | Las Vegas Nevada, United States, 89121ActivMed Practices and Research | Portsmouth New Hampshire, United States, 03801Integrative Clinical Trials LLC | Brooklyn New York, United States, 11229SPRI Clinical Trials, LLC | Brooklyn New York, United States, 11235University at Buffalo Psychiatry | Buffalo New York, United States, 14202Bioscience Research LLC | Mount Kisco New York, United States, 10549Fieve Clinical Research Inc | New York New York, United States, 10017Hapworth Psychiatric Medical PLLC | New York New York, United States, 10022Lucian Miron Manu MD Psychiatry PC | Woodbury New York, United States, 11797IMA Clinical Research PC 3 | Hickory North Carolina, United States, 28601Haidar Almhana Nieding | Avon Lake Ohio, United States, 44012Patient Priority Clinical Sites LLC | Cincinnati Ohio, United States, 45215University of Cincinnati College of Medicine | Cincinnati Ohio, United States, 45219The Ohio State University | Columbus Ohio, United States, 43210North Star Medical Research | Middleburg Heights Ohio, United States, 44130Conrad Clinical Research | Edmond Oklahoma, United States, 73013University of Pennsylvania | Philadelphia Pennsylvania, United States, 19104Clinical Trials of South Carolina | Charleston South Carolina, United States, 29406Medical University of South Carolina | Charleston South Carolina, United States, 29425The University of Texas at Austin | Austin Texas, United States, 78712BioBehavioral Research of Austin PC | Austin Texas, United States, 78759Houston Clinical Trials LLC | Bellaire Texas, United States, 77401Relaro Medical Trials | Dallas Texas, United States, 75243North Texas Clinical Trials | Fort Worth Texas, United States, 76104VAST Clinical Research | Garland Texas, United States, 75041Baylor College of Medicine | Houston Texas, United States, 77030DM Clinical Research | Houston Texas, United States, 77081R and H Clinical Research | Stafford Texas, United States, 77477Grayline Research Center | Wichita Falls Texas, United States, 76309Cedar Clinical Research | Draper Utah, United States, 84020Core Clinical Research | Everett Washington, United States, 98201Fundacion para el Estudio y Tratamiento de las Enfermedades Mentales | Buenos Aires , Argentina, C1133AAHCEN Consultorios Especializados en Neurociencias | Córdoba , Argentina, 5000FJFInstituto Medico DAMIC | Córdoba , Argentina, X5003DCECentro Medico Luquez | Córdoba , Argentina, X5006IKKSanatorio Prof Leon S Morra S A | Córdoba , Argentina, X5009BININSA Instituto de Neurociencias San Agustín | La Plata , Argentina, 1900C I A P Centro de investigacion y Asistencia en Psiquiatria | Rosario , Argentina, 2000Clinica El Jardin | Santiago del Estero , Argentina, 4200L2IP Instituto de Pesquisas Clinicas | Brasília , Brazil, 70200 730CAEP Centro Avancado De Estudos E Pesquisas | Campinas , Brazil, 13087 567Sociedade Literaria e Caritativa Santo Agostinho Hospital Sao Jose | Criciúma , Brazil, 88811 000Universidade Federal do Rio Grande do Norte Hospital Universitario Onofre Lopes | Natal , Brazil, 59012 300Instituto Mederi de Pesquisa e Saude | Passo Fundo , Brazil, 99010 120Hospital De Clinicas De Porto Alegre | Porto Alegre , Brazil, 90035 903NPCRS Nucleo de Pesquisa Clinica do Rio Grande do Sul | Porto Alegre , Brazil, 90430001Uniao Brasileira de Educacao e Assistencia INSCER Instituto do Cerebro do Rio Grande do Sul | Porto Alegre , Brazil, 90619900Ruschel Medicina e Pesquisa Clínica Ltda | Rio de Janeiro , Brazil, 22270 060Centro Integrado Facili | São Bernardo do Campo , Brazil, 09726 150CPQuali Pesquisa Clinica LTDA ME | São Paulo , Brazil, 01228 000BR Trials | São Paulo , Brazil, 01236030Mental Health Center Prof. Dr. Ivan Temkov | Burgas , Bulgaria, 8001UMHAT 'Sveti Georgi'- Plovdiv, Psychiatry Clinic | Plovdiv , Bulgaria, 4002Medical Center St. Naum | Sofia , Bulgaria, 1113Centre for Mental Health Prof.N.Shipkovenski EOOD | Sofia , Bulgaria, 1377DCC 'Sv. Vrach and Sv. Sv. Kuzma and Damyan', OOD | Sofia , Bulgaria, 1408Medical Center ZaraMed | Stara Zagora , Bulgaria, 6003Diagnostic Consulting Center Mladost - M Varna | Varna , Bulgaria, 9020Centro de Investigaciones y Proyectos en Neurociencias CIPNA | Barranquilla , Colombia, 080002HOMO - ESE Hospital Mental de Antioquia | Bello , Colombia, 051053Centro de Investigaciones del Sistema Nervioso Grupo Cisne Ltda. | Bogotá , Colombia, 111166Psynapsis Salud Mental S.A. | Pereira , Colombia, 660001Medipa S R O | Brno , Czechia, 61300A Shine S R O | Pilsen , Czechia, 301 00Clintrial s r o | Prague , Czechia, 10000Neuropsychiatrie Petrska sro | Prague , Czechia, 110 00Pragtis S R O | Prague , Czechia, 12000Medical Services Prague S R O | Prague , Czechia, 16000Territorial Social Health Authority of the Spedali Civili of Brescia | Brescia , Italy, 25123Azienda Ospedaliero Univ. Policlinico Gaspare Rodolico | Catania , Italy, 95123Universita D Annunzio | Chieti , Italy, 66100IRCCS Aor San Martino IST | Genova , Italy, 16132Fondazione IRCCS San Gerardo dei Tintori | Monza , Italy, 20900Azienda Ospedaliero Universitaria Pisana | Pisa , Italy, 56126Policlinico Universitario Agostino Gemelli | Roma , Italy, 00168Azienda Ospedaliera Sant Andrea | Roma , Italy, 00189Ospedale S Francesco d Assisi | Salerno , Italy, 84020A O Universitaria Senese Ospedale Santa Maria alle Scotte | Siena , Italy, 53100Health Pharma Professional Research | Mexico City , Mexico, 03100Ketamine Mexico S de RL de C V | Mexico City , Mexico, 04100Gabipros SC | Mexico City , Mexico, 07000Instituto de Informacion e Investigacion en Salud Mental A.C. | Monterrey , Mexico, 64710Hospital Universitario Dr Jose Eleuterio Gonzalez | Nuevo León , Mexico, 64460Centro de Estudios Clinicos y Especialidades Medicas S C | Nuevo León , Mexico, 64620Hospital Lomas de San Luis Internacional | San Luis de Potosi , Mexico, 78218Centrum Medyczne Intercor Sp z o o | Bydgoszcz , Poland, 85 605Osrodek Badan Klinicznych CLINSANTE S C Ewa Galczak Nowak Malgorzata Trzaska | Bydgoszcz , Poland, 85 794PROMENTE Sp. z o.o. | Bydgoszcz , Poland, 85-133Centrum Zdrowia Alcea | Gdansk , Poland, 80 283Specjalistyczna Praktyka Lekarska Piotr Zalitacz | Gorlice , Poland, 30073Przychodnie Grudziadz sp. z o.o. | Grudziądz , Poland, 86 300Clinic BBP | Katowice , Poland, 40 514Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS | Leszno , Poland, 64-100Praktyka Lekarska dr n med Malgorzata Wojtanowska Bogacka | Poznan , Poland, 60 192Szpital Nowowiejski Osrodek Badan Klinicznych | Warsaw , Poland, 00-774MTZ Clinical Research Powered by Pratia | Warsaw , Poland, 02-172Uls Braga - Hosp. Braga | Braga , Portugal, 4710 243Uls Regiao Leiria - Hosp. Santo Andre | Leiria , Portugal, 2410 197Uls Lisboa Ocidental - Hosp. Egas Moniz | Lisbon , Portugal, 1349 019Fund. Champalimaud | Lisbon , Portugal, 1400 038Uls Santa Maria - Hosp. Santa Maria | Lisbon , Portugal, 1649 035Uls Loures Odivelas - Hosp. Loures | Loures , Portugal, 2674 514Hosp. Divino Espirito Santo Ponta Delgada | Ponta Delgada , Portugal, 9500 370Hosp. Cuf Porto | Porto , Portugal, 4100 180Hosp. Central Trofa Saude | Touguinho , Portugal, 4480-565Spitalul Clinic de Psihiatrie Prof Dr Alexandru Obregia 2 | Bucharest , Romania, 041914Spitalul Clinic de Psihiatrie Prof Dr Alexandru Obregia | Bucharest , Romania, 041914Spitalul Clinic Judetean de Urgenta Cluj Napoca 1 | Cluj-Napoca , Romania, 400012Spitalul Clinic Judetean de Urgenta Cluj Napoca | Cluj-Napoca , Romania, 400012Centrul Medical Melchisedec | Craiova , Romania, 200157CMI Dr. Sarpe Marcel-Claudiu | Focşani , Romania, 620117Institutului Regional de Psihiatrie 'Socola' Iasi | Iași , Romania, 700282Institutului Regional de Psihiatrie Socola Iasi 1 | Iași , Romania, 700282Institutului Regional de Psihiatrie Socola Iasi 2 | Iași , Romania, 700282Spitalul Clinic Judetean de Urgenta Oradea | Oradea , Romania, 410169Spitalul de Psihiatrie si Neurologie Brasov | Sânpetru , Romania, 507190Spitalul Clinic De Psihiatrie Doctor Gheorghe Preda 1 | Sibiu , Romania, 550082Spitalul Clinic De Psihiatrie Doctor Gheorghe Preda | Sibiu , Romania, 550082University Clinical Center of Serbia | Belgrade , Serbia, 11000University Clinical Hospital Center Dr Dragisa Misovic- Dedi | Belgrade , Serbia, 11000Special Hospital for Psychiatric Diseases Gornja Toponica | Gornja Toponica , Serbia, 18202Special Hospital for Psychiatric Diseases Kovin | Kovin , Serbia, 26220Specialized Hospital for Psychiatric Diseases Sveti Vracevi | Novi Kneževac , Serbia, 23330Psychiatricka Ambulancia Mentum S.R.O. | Bratislava , Slovakia, 821 01Univerzitna nemocnica L. Pasteura Kosice | Košice , Slovakia, 040 01Liptovska Nemocnica S Poliklinikou Mudr. Ivana Stodolu | Liptovský Mikuláš , Slovakia, 031 23Psychiatricka Ambulancia Psycholine S.R.O. | Rimavská Sobota , Slovakia, 979 01Psychiatricka Ambulancia Centrum Zdravia R.B.K. S.R.O. | Svidník , Slovakia, 089 01Crystal Comfort s.r.o. | Vranov nad Topľou , Slovakia, 093 01Institucion Hosp Hestia Palau | Barcelona , Spain, 08025Hosp Clinic de Barcelona | Barcelona , Spain, 08036Hosp Univ Vall D Hebron | Barcelona , Spain, 8035Hosp. Univ. de Basurto | Bilbao , Spain, 48013Hosp. Gral. de Villalba | Collado Villalba , Spain, 28400Hosp. Univ. Infanta Leonor | Madrid , Spain, 28031Hospital Ramon y Cajal | Madrid , Spain, 28034Hosp. Univ. La Paz | Madrid , Spain, 28046Hosp. Univ. de Torrevieja | Torrevieja , Spain, 03186ProbarE i Lund AB | Lund , Sweden, 22222CTC GoCo | Mölndal , Sweden, 43153ProbarE i Stockholm AB | Stockholm , Sweden, 114 37CTC MTC Uppsala | Uppsala , Sweden, 75237Gulhane Egitim ve Arastirma Hastanesi | Ankara , Turkey (Türkiye), 06010Ankara University Medical Faculty | Ankara , Turkey (Türkiye), 06620Ankara Bilkent Sehir Hastanesi | Ankara , Turkey (Türkiye), 06800Uludag Universitesi Tıp Fakultesi Hastanesi | Bursa , Turkey (Türkiye), 16059Bursa High Speciality Training and Research Dortcelik Mental Hospital | Bursa , Turkey (Türkiye), 16285Gaziantep Universitesi Tip Fakultesi | Gaziantep , Turkey (Türkiye), 27580Erenkoy Mental Hospital | Istanbul , Turkey (Türkiye), 34736Kocaeli University Medical Faculty | Kocaeli , Turkey (Türkiye), 41001Liv Hospital | Samsun , Turkey (Türkiye), 55020Karadeniz Teknik University Medical Faculty | Trabzon , Turkey (Türkiye), 61080
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trail, Janssen Research & Development, LLC