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| ID | Type | Description | Link |
|---|---|---|---|
| 42847922MDD3003 | Other Identifier | Janssen Research & Development, LLC | |
| 2023-509070-36-00 | Registry Identifier | EUCT number |
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The purpose of this study is to know how well seltorexant works, and also to evaluate safety and maintenance effect of seltorexant compared with placebo as an 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 a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Seltorexant | Experimental | 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. |
|
| Part 1: Placebo | Placebo Comparator | 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. |
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| Part 2: Open Label (OL) Seltorexant | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Seltorexant | Drug | Seltorexant will be administered orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Day 43 |
| 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. | Time from randomization to the first Relapse during the maintenance phase (up to 2 years and 10 months) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Day 43 |
| 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 |
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Inclusion Criteria:
Participants in part 1 and direct enrollers to part 2:
Participants entering after completing part 1:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Contact | Contact | 844-434-4210 | Participate-In-This-Study1@its.jnj.com |
| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trail | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Completed | Birmingham | Alabama | 35294 | United States | |
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www janssen, com/clinical-trialsitransparency. 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
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| Part 2: DB Seltorexant | Experimental | 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. |
|
| Part 2: DB Placebo | Placebo Comparator | 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. |
|
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| Placebo | Drug | Matching Placebo tablets will be administered orally. |
|
| Selective Serotonin Reuptake Inhibitor (SSRI)/Serotonin-Norepinephrine Reuptake Inhibitor (SNRI) | Drug | SSRI/SNRI will be administered orally. |
|
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. |
| Baseline, Day 43 |
| 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). | Baseline, Day 43 |
| 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. | From Baseline to Day 43 |
| 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. | Baseline, Day 43 |
| 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. | Baseline, Day 43 |
| 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. | Baseline, Day 43 |
| 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. | Time from randomization to the first relapse during the maintenance phase (up to 2 years and 10 months) |
| 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. | From Baseline (Day 1 in the DB treatment maintenance Phase) until end point of the DB maintenance phase (that is up to Day 337) |
| 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. | From Baseline (Day 1 in the DB treatment maintenance Phase) until end point of the DB maintenance phase (that is up to Day 337) |
| 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. | Baseline, Day 43 |
| 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. | From Baseline (Day 1 in the DB treatment maintenance Phase) until end point of the DB maintenance phase (that is up to Day 337) |
| 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. | From Baseline (Day 1 in the DB Treatment Maintenance Phase) Until End Point of the DB Maintenance Phase (that is, up to Day 337) |
| 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). | From Baseline (Day 1 in the DB treatment maintenance Phase) until end point of the DB maintenance phase (that is up to Day 337) |
| 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. | From Baseline (Day 1 in the DB treatment maintenance Phase) until end point of the DB maintenance phase (that is up to Day 337) |
| Chandler Clinical Trials |
| Completed |
| Chandler |
| Arizona |
| 85224 |
| United States |
| University of Arizona | Recruiting | Tucson | Arizona | 85724 | United States |
| SanRo Clinical Research Group LLC WCG Clinical Network | Recruiting | Bryant | Arkansas | 72022 | United States |
| Preferred Research Partners | Completed | Little Rock | Arkansas | 72211 | United States |
| PAMOJA Clinical Institute LLC | Recruiting | Anaheim | California | 92801 | United States |
| Axiom Research | Recruiting | Colton | California | 92324 | United States |
| Elite Research Network 6 | Completed | Encino | California | 91316 | United States |
| Behavioral Research Specialists LLC | Completed | Glendale | California | 91206 | United States |
| WR PRI Los Alamitos | Completed | Los Alamitos | California | 90720 | United States |
| Excell Research Inc | Recruiting | Oceanside | California | 92056 | United States |
| Prospective Research Innovations Inc | Completed | Rancho Cucamonga | California | 91730 | United States |
| Anderson Clinical Research | Recruiting | Redlands | California | 92374 | United States |
| Lumos Clinical Research Center LLC | Recruiting | San Jose | California | 95124 | United States |
| Syrentis Clinical Research | Completed | Santa Ana | California | 92705 | United States |
| California Neuroscience Research | Completed | Sherman Oaks | California | 91403 | United States |
| Mountain View Clinical Research | Recruiting | Denver | Colorado | 80209 | United States |
| UConn Health Center | Recruiting | Farmington | Connecticut | 06030 | United States |
| Clinical Research of Brandon | Recruiting | Brandon | Florida | 33511 | United States |
| AGA Clinical Trials | Recruiting | Hialeah | Florida | 33012 | United States |
| Reliable Clinical Research | Recruiting | Hialeah | Florida | 33012 | United States |
| Advanced Research Institute of Miami | Recruiting | Homestead | Florida | 33033 | United States |
| Clinical NeuroScience Solutions Inc | Recruiting | Jacksonville | Florida | 32256 | United States |
| Multi Specialty Research Associates Inc | Completed | Lake City | Florida | 32055 | United States |
| Alcanza Clinical Research | Completed | Largo | Florida | 33777 | United States |
| Pharmax Research Clinic Inc | Recruiting | Miami | Florida | 33126 | United States |
| Miami Dade Medical Research Institute | Recruiting | Miami | Florida | 33176 | United States |
| Nuovida Research Center | Recruiting | Miami | Florida | 33186 | United States |
| Aqualane Clinical Research | Completed | Naples | Florida | 34105 | United States |
| Bravo Health Care Center | Completed | North Bay Village | Florida | 33141 | United States |
| Nova Psychiatry INC | Recruiting | Orlando | Florida | 32803 | United States |
| Florida Center for TMS | Completed | Saint Augustine | Florida | 32086 | United States |
| University of South Florida | Completed | Tampa | Florida | 33613 | United States |
| Psych Me Medical Research Inc | Recruiting | Tampa | Florida | 33614 | United States |
| Interventional Psychiatry of Tampa Bay | Recruiting | Tampa | Florida | 33629 | United States |
| Health Synergy Clinical Research | Recruiting | West Palm Beach | Florida | 33407 | United States |
| Conquest Research | Completed | Winter Park | Florida | 32789 | United States |
| Advanced Discovery Research | Recruiting | Atlanta | Georgia | 30318 | United States |
| Agile Clinical Research Trials, LLC | Active, not recruiting | Atlanta | Georgia | 30328 | United States |
| iResearch Atlanta LLC | Recruiting | Decatur | Georgia | 30030 | United States |
| Peachford Hospital-Atlanta Behavorial Research | Completed | Dunwoody | Georgia | 30338 | United States |
| iResearch Savannah | Completed | Savannah | Georgia | 31405 | United States |
| Accelerated Clinical Research Group LLC | Recruiting | Snellville | Georgia | 30078 | United States |
| Renew Health Clinical Research | Completed | Snellville | Georgia | 30078 | United States |
| Northwestern University | Recruiting | Chicago | Illinois | 60611 | United States |
| MetroMed Clinical Research | Completed | Chicago | Illinois | 60614 | United States |
| University of Chicago Medical Center | Completed | Chicago | Illinois | 60637 | United States |
| Revive Research Institute | Completed | Elgin | Illinois | 60123 | United States |
| Baber Research Group | Recruiting | Naperville | Illinois | 60563 | United States |
| Boston Clinical Trials | Completed | Boston | Massachusetts | 02131 | United States |
| Adams Clinical LLC | Recruiting | Watertown | Massachusetts | 02472 | United States |
| Mankato Clinic | Recruiting | Mankato | Minnesota | 56001 | United States |
| Redbird Research | Completed | Las Vegas | Nevada | 89119 | United States |
| Oasis Clinical Research LLC | Completed | Las Vegas | Nevada | 89121 | United States |
| ActivMed Practices and Research | Completed | Portsmouth | New Hampshire | 03801 | United States |
| Integrative Clinical Trials LLC | Recruiting | Brooklyn | New York | 11229 | United States |
| SPRI Clinical Trials, LLC | Recruiting | Brooklyn | New York | 11235 | United States |
| University at Buffalo Psychiatry | Completed | Buffalo | New York | 14202 | United States |
| Bioscience Research LLC | Recruiting | Mount Kisco | New York | 10549 | United States |
| Fieve Clinical Research Inc | Recruiting | New York | New York | 10017 | United States |
| Hapworth Psychiatric Medical PLLC | Completed | New York | New York | 10022 | United States |
| Lucian Miron Manu MD Psychiatry PC | Completed | Woodbury | New York | 11797 | United States |
| IMA Clinical Research PC 3 | Completed | Hickory | North Carolina | 28601 | United States |
| Haidar Almhana Nieding | Completed | Avon Lake | Ohio | 44012 | United States |
| Patient Priority Clinical Sites LLC | Recruiting | Cincinnati | Ohio | 45215 | United States |
| University of Cincinnati College of Medicine | Completed | Cincinnati | Ohio | 45219 | United States |
| The Ohio State University | Recruiting | Columbus | Ohio | 43210 | United States |
| North Star Medical Research | Completed | Middleburg Heights | Ohio | 44130 | United States |
| Conrad Clinical Research | Recruiting | Edmond | Oklahoma | 73013 | United States |
| University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
| Clinical Trials of South Carolina | Recruiting | Charleston | South Carolina | 29406 | United States |
| Medical University of South Carolina | Completed | Charleston | South Carolina | 29425 | United States |
| The University of Texas at Austin | Completed | Austin | Texas | 78712 | United States |
| BioBehavioral Research of Austin PC | Completed | Austin | Texas | 78759 | United States |
| Houston Clinical Trials LLC | Recruiting | Bellaire | Texas | 77401 | United States |
| Relaro Medical Trials | Completed | Dallas | Texas | 75243 | United States |
| North Texas Clinical Trials | Recruiting | Fort Worth | Texas | 76104 | United States |
| VAST Clinical Research | Completed | Garland | Texas | 75041 | United States |
| Baylor College of Medicine | Recruiting | Houston | Texas | 77030 | United States |
| DM Clinical Research | Recruiting | Houston | Texas | 77081 | United States |
| R and H Clinical Research | Recruiting | Stafford | Texas | 77477 | United States |
| Grayline Research Center | Active, not recruiting | Wichita Falls | Texas | 76309 | United States |
| Cedar Clinical Research | Completed | Draper | Utah | 84020 | United States |
| Core Clinical Research | Recruiting | Everett | Washington | 98201 | United States |
| Fundacion para el Estudio y Tratamiento de las Enfermedades Mentales | Active, not recruiting | Buenos Aires | C1133AAH | Argentina |
| CEN Consultorios Especializados en Neurociencias | Recruiting | Córdoba | 5000FJF | Argentina |
| Instituto Medico DAMIC | Recruiting | Córdoba | X5003DCE | Argentina |
| Centro Medico Luquez | Recruiting | Córdoba | X5006CBI | Argentina |
| Sanatorio Prof Leon S Morra S A | Recruiting | Córdoba | X5009BIN | Argentina |
| INSA Instituto de Neurociencias San Agustín | Recruiting | La Plata | 1900 | Argentina |
| C I A P Centro de investigacion y Asistencia en Psiquiatria | Recruiting | Rosario | 2000 | Argentina |
| Clinica El Jardin | Recruiting | Santiago del Estero | 4200 | Argentina |
| L2IP Instituto de Pesquisas Clinicas | Suspended | Brasília | 70200 730 | Brazil |
| CAEP Centro Avancado De Estudos E Pesquisas | Recruiting | Campinas | 13087 567 | Brazil |
| Sociedade Literaria e Caritativa Santo Agostinho Hospital Sao Jose | Recruiting | Criciúma | 88811 000 | Brazil |
| Universidade Federal do Rio Grande do Norte Hospital Universitario Onofre Lopes | Completed | Natal | 59012 300 | Brazil |
| Instituto Mederi de Pesquisa e Saude | Suspended | Passo Fundo | 99010 120 | Brazil |
| Hospital De Clinicas De Porto Alegre | Completed | Porto Alegre | 90035 903 | Brazil |
| NPCRS Nucleo de Pesquisa Clinica do Rio Grande do Sul | Recruiting | Porto Alegre | 90430001 | Brazil |
| Uniao Brasileira de Educacao e Assistencia INSCER Instituto do Cerebro do Rio Grande do Sul | Completed | Porto Alegre | 90619900 | Brazil |
| Ruschel Medicina e Pesquisa Clínica Ltda | Recruiting | Rio de Janeiro | 22270 060 | Brazil |
| Centro Integrado Facili | Recruiting | São Bernardo do Campo | 09726 150 | Brazil |
| CPQuali Pesquisa Clinica LTDA ME | Active, not recruiting | São Paulo | 01228 000 | Brazil |
| BR Trials | Recruiting | São Paulo | 01236030 | Brazil |
| Mental Health Center Prof. Dr. Ivan Temkov | Active, not recruiting | Burgas | 8001 | Bulgaria |
| UMHAT 'Sveti Georgi'- Plovdiv, Psychiatry Clinic | Recruiting | Plovdiv | 4002 | Bulgaria |
| Medical Center St. Naum | Active, not recruiting | Sofia | 1113 | Bulgaria |
| Centre for Mental Health Prof.N.Shipkovenski EOOD | Completed | Sofia | 1377 | Bulgaria |
| DCC 'Sv. Vrach and Sv. Sv. Kuzma and Damyan', OOD | Recruiting | Sofia | 1408 | Bulgaria |
| Medical Center ZaraMed | Completed | Stara Zagora | 6010 | Bulgaria |
| Diagnostic Consulting Center Mladost - M Varna | Active, not recruiting | Varna | 9020 | Bulgaria |
| Centro de Investigaciones y Proyectos en Neurociencias CIPNA | Recruiting | Barranquilla | 080002 | Colombia |
| HOMO - ESE Hospital Mental de Antioquia | Recruiting | Bello | 051053 | Colombia |
| Centro de Investigaciones del Sistema Nervioso Grupo Cisne Ltda. | Recruiting | Bogotá | 111166 | Colombia |
| Psynapsis Salud Mental S.A. | Recruiting | Pereira | 660001 | Colombia |
| Medipa S R O | Recruiting | Brno | 61300 | Czechia |
| A Shine S R O | Completed | Pilsen | 301 00 | Czechia |
| Clintrial s r o | Recruiting | Prague | 10000 | Czechia |
| Neuropsychiatrie Petrska sro | Recruiting | Prague | 110 00 | Czechia |
| Pragtis S R O | Completed | Prague | 12000 | Czechia |
| Medical Services Prague S R O | Recruiting | Prague | 16000 | Czechia |
| Territorial Social Health Authority of the Spedali Civili of Brescia | Completed | Brescia | 25123 | Italy |
| Azienda Ospedaliero Univ. Policlinico Gaspare Rodolico | Recruiting | Catania | 95123 | Italy |
| Universita D Annunzio | Recruiting | Chieti | 66100 | Italy |
| IRCCS Aor San Martino IST | Completed | Genova | 16132 | Italy |
| Fondazione IRCCS San Gerardo dei Tintori | Completed | Monza | 20900 | Italy |
| Azienda Ospedaliero Universitaria Pisana | Completed | Pisa | 56126 | Italy |
| Policlinico Universitario Agostino Gemelli | Completed | Roma | 00168 | Italy |
| Azienda Ospedaliera Sant Andrea | Recruiting | Roma | 00189 | Italy |
| Ospedale S Francesco d Assisi | Completed | Salerno | 84020 | Italy |
| A O Universitaria Senese Ospedale Santa Maria alle Scotte | Recruiting | Siena | 53100 | Italy |
| Health Pharma Professional Research | Completed | Mexico City | 03100 | Mexico |
| Ketamine Mexico S de RL de C V | Recruiting | Mexico City | 04100 | Mexico |
| Gabipros SC | Recruiting | Mexico City | 07000 | Mexico |
| Instituto de Informacion e Investigacion en Salud Mental A.C. | Recruiting | Monterrey | 64710 | Mexico |
| Hospital Universitario Dr Jose Eleuterio Gonzalez | Recruiting | Nuevo León | 64460 | Mexico |
| Centro de Estudios Clinicos y Especialidades Medicas S C | Recruiting | Nuevo León | 64620 | Mexico |
| Hospital Lomas de San Luis Internacional | Recruiting | San Luis de Potosi | 78218 | Mexico |
| Centrum Medyczne Intercor Sp z o o | Completed | Bydgoszcz | 85 605 | Poland |
| Osrodek Badan Klinicznych CLINSANTE S C Ewa Galczak Nowak Malgorzata Trzaska | Recruiting | Bydgoszcz | 85 794 | Poland |
| PROMENTE Sp. z o.o. | Recruiting | Bydgoszcz | 85-133 | Poland |
| Centrum Zdrowia Alcea | Recruiting | Gdansk | 80 283 | Poland |
| Specjalistyczna Praktyka Lekarska Piotr Zalitacz | Completed | Gorlice | 30073 | Poland |
| Przychodnie Grudziadz sp. z o.o. | Recruiting | Grudziądz | 86 300 | Poland |
| Clinic BBP Sp z o o | Recruiting | Katowice | 40 514 | Poland |
| Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS | Recruiting | Leszno | 64-100 | Poland |
| Praktyka Lekarska dr n med Malgorzata Wojtanowska Bogacka | Recruiting | Poznan | 60 192 | Poland |
| Szpital Nowowiejski Osrodek Badan Klinicznych | Recruiting | Warsaw | 00-774 | Poland |
| MTZ Clinical Research Powered by Pratia | Completed | Warsaw | 02-172 | Poland |
| Uls Braga - Hosp. Braga | Completed | Braga | 4710 243 | Portugal |
| Uls Regiao Leiria - Hosp. Santo Andre | Recruiting | Leiria | 2410 197 | Portugal |
| Uls Lisboa Ocidental - Hosp. Egas Moniz | Recruiting | Lisbon | 1349 019 | Portugal |
| Fund. Champalimaud | Recruiting | Lisbon | 1400 038 | Portugal |
| Uls Santa Maria - Hosp. Santa Maria | Completed | Lisbon | 1649 035 | Portugal |
| Uls Loures Odivelas - Hosp. Loures | Recruiting | Loures | 2674 514 | Portugal |
| Hosp. Divino Espirito Santo Ponta Delgada | Completed | Ponta Delgada | 9500 370 | Portugal |
| Hosp. Cuf Porto | Recruiting | Porto | 4100 180 | Portugal |
| Hosp. Central Trofa Saude | Completed | Touguinho | 4480-565 | Portugal |
| Spitalul Clinic de Psihiatrie Prof Dr Alexandru Obregia 2 | Completed | Bucharest | 041914 | Romania |
| Spitalul Clinic de Psihiatrie Prof Dr Alexandru Obregia | Recruiting | Bucharest | 041914 | Romania |
| Spitalul Clinic Judetean de Urgenta Cluj Napoca 1 | Completed | Cluj-Napoca | 400012 | Romania |
| Spitalul Clinic Judetean de Urgenta Cluj Napoca | Completed | Cluj-Napoca | 400012 | Romania |
| Centrul Medical Melchisedec | Recruiting | Craiova | 200157 | Romania |
| CMI Dr. Sarpe Marcel-Claudiu | Completed | Focşani | 620117 | Romania |
| Institutului Regional de Psihiatrie 'Socola' Iasi | Completed | Iași | 700282 | Romania |
| Institutului Regional de Psihiatrie Socola Iasi 1 | Completed | Iași | 700282 | Romania |
| Institutului Regional de Psihiatrie Socola Iasi 2 | Completed | Iași | 700282 | Romania |
| Spitalul Clinic Judetean de Urgenta Oradea | Recruiting | Oradea | 410169 | Romania |
| Spitalul de Psihiatrie si Neurologie Brasov | Recruiting | Sânpetru | 507190 | Romania |
| Spitalul Clinic De Psihiatrie Doctor Gheorghe Preda 1 | Completed | Sibiu | 550082 | Romania |
| Spitalul Clinic De Psihiatrie Doctor Gheorghe Preda | Completed | Sibiu | 550082 | Romania |
| University Clinical Center of Serbia | Recruiting | Belgrade | 11000 | Serbia |
| University Clinical Hospital Center Dr Dragisa Misovic- Dedi | Recruiting | Belgrade | 11000 | Serbia |
| Special Hospital for Psychiatric Diseases Gornja Toponica | Recruiting | Gornja Toponica | 18202 | Serbia |
| Special Hospital for Psychiatric Diseases Kovin | Recruiting | Kovin | 26220 | Serbia |
| Specialized Hospital for Psychiatric Diseases Sveti Vracevi | Recruiting | Novi Kneževac | 23330 | Serbia |
| Psychiatricka Ambulancia Mentum S.R.O. | Completed | Bratislava | 821 01 | Slovakia |
| Univerzitna nemocnica L. Pasteura Kosice | Recruiting | Košice | 040 01 | Slovakia |
| Liptovska Nemocnica S Poliklinikou Mudr. Ivana Stodolu | Recruiting | Liptovský Mikuláš | 031 23 | Slovakia |
| Psychiatricka Ambulancia Psycholine S.R.O. | Recruiting | Rimavská Sobota | 979 01 | Slovakia |
| Psychiatricka Ambulancia Centrum Zdravia R.B.K. S.R.O. | Recruiting | Svidník | 089 01 | Slovakia |
| Crystal Comfort s.r.o. | Recruiting | Vranov nad Topľou | 093 01 | Slovakia |
| Institucion Hosp Hestia Palau | Recruiting | Barcelona | 08025 | Spain |
| Hosp Clinic de Barcelona | Recruiting | Barcelona | 08036 | Spain |
| Hosp Univ Vall D Hebron | Recruiting | Barcelona | 8035 | Spain |
| Hosp. Univ. de Basurto | Completed | Bilbao | 48013 | Spain |
| Hosp. Gral. de Villalba | Recruiting | Collado Villalba | 28400 | Spain |
| Hosp. Univ. Infanta Leonor | Recruiting | Madrid | 28031 | Spain |
| Hospital Ramon y Cajal | Recruiting | Madrid | 28034 | Spain |
| Hosp. Univ. La Paz | Recruiting | Madrid | 28046 | Spain |
| Hosp. Univ. de Torrevieja | Recruiting | Torrevieja | 03186 | Spain |
| ProbarE i Lund AB | Recruiting | Lund | 22222 | Sweden |
| CTC GoCo | Recruiting | Mölndal | 43153 | Sweden |
| ProbarE i Stockholm AB | Recruiting | Stockholm | 114 37 | Sweden |
| CTC MTC Uppsala | Recruiting | Uppsala | 75237 | Sweden |
| Gulhane Egitim ve Arastirma Hastanesi | Recruiting | Ankara | 06010 | Turkey (Türkiye) |
| Ankara University Medical Faculty | Completed | Ankara | 06620 | Turkey (Türkiye) |
| Ankara Bilkent Sehir Hastanesi | Recruiting | Ankara | 06800 | Turkey (Türkiye) |
| Uludag Universitesi Tıp Fakultesi Hastanesi | Recruiting | Bursa | 16059 | Turkey (Türkiye) |
| Bursa High Speciality Training and Research Dortcelik Mental Hospital | Completed | Bursa | 16285 | Turkey (Türkiye) |
| Gaziantep Universitesi Tip Fakultesi | Recruiting | Gaziantep | 27580 | Turkey (Türkiye) |
| Erenkoy Mental Hospital | Completed | Istanbul | 34736 | Turkey (Türkiye) |
| Kocaeli University Medical Faculty | Recruiting | Kocaeli | 41001 | Turkey (Türkiye) |
| Liv Hospital | Recruiting | Samsun | 55020 | Turkey (Türkiye) |
| Karadeniz Teknik University Medical Faculty | Completed | Trabzon | 61080 | Turkey (Türkiye) |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C000655226 | seltorexant |
| D017367 | Selective Serotonin Reuptake Inhibitors |
| ID | Term |
|---|---|
| D014179 | Neurotransmitter Uptake Inhibitors |
| D049990 | Membrane Transport Modulators |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D018377 | Neurotransmitter Agents |
| D018490 | Serotonin Agents |
| D045505 | Physiological Effects of Drugs |
Not provided
Not provided