Phase 3 Study of Adjunctive Treatment With Seltorexant in Adult and Elderly Participants With Major Depressive Disorder and Insomnia Symptoms
- Conditions
- Depressive Disorder, Major
- Interventions
- Drug: PlaceboDrug: Selective Serotonin Reuptake Inhibitor (SSRI)/Serotonin-Norepinephrine Reuptake Inhibitor (SNRI)
- Registration Number
- NCT06559306
- Lead Sponsor
- Janssen Research & Development, LLC
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 752
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 1: Placebo 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. Part 1: Placebo Selective Serotonin Reuptake Inhibitor (SSRI)/Serotonin-Norepinephrine Reuptake Inhibitor (SNRI) 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. Part 2: Open Label (OL) Seltorexant Selective Serotonin Reuptake Inhibitor (SSRI)/Serotonin-Norepinephrine Reuptake Inhibitor (SNRI) 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. Part 1: Seltorexant Selective Serotonin Reuptake Inhibitor (SSRI)/Serotonin-Norepinephrine Reuptake Inhibitor (SNRI) 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 2: DB Seltorexant 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. Part 2: DB Seltorexant Selective Serotonin Reuptake Inhibitor (SSRI)/Serotonin-Norepinephrine Reuptake Inhibitor (SNRI) 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 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. Part 2: DB Placebo Selective Serotonin Reuptake Inhibitor (SSRI)/Serotonin-Norepinephrine Reuptake Inhibitor (SNRI) 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. Part 2: Open Label (OL) Seltorexant 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. Part 1: Seltorexant 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.
- Primary Outcome Measures
Name Time Method Part 1: Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Day 43 Baseline, 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.
Part 2: Time from Randomization to the First Relapse in Participants Who Achieve a Stable Response Time from randomization to the first Relapse during the maintenance phase (up to 2 years and 10 months) 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
Name Time Method Part 1: Change from Baseline in the MADRS Without Sleep Item (MADRS-WOSI) Total Score at Day 43 Baseline, 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.
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 Baseline, 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.
Part 1: Change from Baseline in the MADRS-6 Total Score at Day 43 Baseline, 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).
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 From Baseline to Day 43 Responders are defined as participants with \>= 50 percent improvement in the MADRS total score 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 Baseline, 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.
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 Baseline, 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.
Part 1: Change from Baseline in Patient Health Questionnaire, 9-Item (PHQ-9) Total Score at Day 43 Baseline, 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.
Part 2: Time from Randomization to the First Relapse in Participants Who Achieve a Stable Remission Time from randomization to the first relapse during the maintenance phase (up to 2 years and 10 months) 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.
Part 2: Change from Baseline to Endpoint of the DB Maintenance Phase in Sleep Disturbance Using the PROMIS-SD Short Form (8a) T-Score From Baseline (Day 1 in the DB treatment maintenance Phase) until end point of the DB maintenance phase (that is up to Day 337) 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.
Part 2: Change from Baseline to Endpoint of the DB Maintenance Phase in Sleep Disturbance Using the PROMIS-SD Short Form (4a) T-Score From Baseline (Day 1 in the DB treatment maintenance Phase) until end point of the DB maintenance phase (that is up to Day 337) 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.
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 Baseline, 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.
Part 2: Change from Baseline to Endpoint of the DB Maintenance Phase in MADRS Total Score From Baseline (Day 1 in the DB treatment maintenance Phase) until end point of the DB maintenance phase (that is up to Day 337) 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.
Part 2: Change from Baseline to Endpoint of DB Maintenance Phase in PHQ-9 Score From Baseline (Day 1 in the DB Treatment Maintenance Phase) Until End Point of the DB Maintenance Phase (that is, up to Day 337) 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.
Change From Baseline to Endpoint of the DB Maintenance Phase in the MADRS-6 score From Baseline (Day 1 in the DB treatment maintenance Phase) until end point of the DB maintenance phase (that is up to Day 337) 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).
Change from Baseline to Endpoint of the DB Maintenance Phase in the MADRS symptoms other than insomnia MADRS Without Sleep Item (MADRS-WOSI) From Baseline (Day 1 in the DB treatment maintenance Phase) until end point of the DB maintenance phase (that is up to Day 337) 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.
Trial Locations
- Locations (159)
DCC 'Sv. Vrach and Sv. Sv. Kuzma and Damyan', OOD
🇧🇬Sofia, Bulgaria
Medical Center ZaraMed
🇧🇬Stara Zagora, Bulgaria
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Chandler Clinical Trials
🇺🇸Chandler, Arizona, United States
University of Arizona
🇺🇸Tucson, Arizona, United States
SanRo Clinical Research Group LLC WCG Clinical Network
🇺🇸Bryant, Arkansas, United States
Preferred Research Partners
🇺🇸Little Rock, Arkansas, United States
PAMOJA Clinical Institute LLC
🇺🇸Anaheim, California, United States
Axiom Research
🇺🇸Colton, California, United States
Elite Research Network
🇺🇸Encino, California, United States
Behavioral Research Specialists LLC
🇺🇸Glendale, California, United States
WR PRI Los Alamitos
🇺🇸Los Alamitos, California, United States
Excell Research Inc
🇺🇸Oceanside, California, United States
Prospective Research Innovations Inc
🇺🇸Rancho Cucamonga, California, United States
Anderson Clinical Research
🇺🇸Redlands, California, United States
Lumos Clinical Research Center LLC
🇺🇸San Jose, California, United States
Syrentis Clinical Research
🇺🇸Santa Ana, California, United States
California Neuroscience Research
🇺🇸Sherman Oaks, California, United States
Mountain View Clinical Research
🇺🇸Denver, Colorado, United States
UConn Health Center
🇺🇸Farmington, Connecticut, United States
Clinical Research of Brandon
🇺🇸Brandon, Florida, United States
AGA Clinical Trials
🇺🇸Hialeah, Florida, United States
Reliable Clinical Research
🇺🇸Hialeah, Florida, United States
Advanced Research Institute of Miami
🇺🇸Homestead, Florida, United States
Clinical NeuroScience Solutions Inc
🇺🇸Jacksonville, Florida, United States
Multi Specialty Research Associates Inc
🇺🇸Lake City, Florida, United States
Alcanza Clinical Research
🇺🇸Largo, Florida, United States
Pharmax Research Clinic Inc
🇺🇸Miami, Florida, United States
Miami Dade Medical Research Institute
🇺🇸Miami, Florida, United States
Nuovida Research Center
🇺🇸Miami, Florida, United States
Aqualane Clinical Research
🇺🇸Naples, Florida, United States
Bravo Health Care Center
🇺🇸North Bay Village, Florida, United States
Nova Psychiatry INC
🇺🇸Orlando, Florida, United States
Florida Center for TMS
🇺🇸Saint Augustine, Florida, United States
Psych Me Medical Research Inc
🇺🇸Tampa, Florida, United States
Interventional Psychiatry of Tampa Bay
🇺🇸Tampa, Florida, United States
Health Synergy Clinical Research
🇺🇸West Palm Beach, Florida, United States
Conquest Research
🇺🇸Winter Park, Florida, United States
Advanced Discovery Research
🇺🇸Atlanta, Georgia, United States
Agile Clinical Research Trials, LLC
🇺🇸Atlanta, Georgia, United States
iResearch Atlanta LLC
🇺🇸Decatur, Georgia, United States
Peachford Hospital-Atlanta Behavorial Research
🇺🇸Dunwoody, Georgia, United States
Accelerated Clinical Research Group LLC
🇺🇸Peachtree Corners, Georgia, United States
iResearch Savannah
🇺🇸Savannah, Georgia, United States
Renew Health Clinical Research
🇺🇸Snellville, Georgia, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Revive Research Institute
🇺🇸Elgin, Illinois, United States
Baber Research Group
🇺🇸Naperville, Illinois, United States
Boston Clinical Trials
🇺🇸Boston, Massachusetts, United States
Adams Clinical LLC
🇺🇸Watertown, Massachusetts, United States
Mankato Clinic
🇺🇸Mankato, Minnesota, United States
Redbird Research
🇺🇸Las Vegas, Nevada, United States
Oasis Clinical Research LLC
🇺🇸Las Vegas, Nevada, United States
ActivMed Practices and Research
🇺🇸Portsmouth, New Hampshire, United States
Integrative Clinical Trials LLC
🇺🇸Brooklyn, New York, United States
SPRI Clinical Trials, LLC
🇺🇸Brooklyn, New York, United States
University at Buffalo Psychiatry
🇺🇸Buffalo, New York, United States
Bioscience Research LLC
🇺🇸Mount Kisco, New York, United States
Fieve Clinical Research Inc
🇺🇸New York, New York, United States
Hapworth Psychiatric Medical PLLC
🇺🇸New York, New York, United States
Lucian Miron Manu MD Psychiatry PC
🇺🇸Woodbury, New York, United States
Haidar Almhana Nieding
🇺🇸Avon Lake, Ohio, United States
Patient Priority Clinical Sites LLC
🇺🇸Cincinnati, Ohio, United States
University of Cincinnati College of Medicine
🇺🇸Cincinnati, Ohio, United States
The Ohio State University
🇺🇸Columbus, Ohio, United States
North Star Medical Research
🇺🇸Middleburg Heights, Ohio, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Clinical Trials of South Carolina
🇺🇸Charleston, South Carolina, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
BioBehavioral Research of Austin PC
🇺🇸Austin, Texas, United States
Houston Clinical Trials LLC
🇺🇸Bellaire, Texas, United States
Relaro Medical Trials
🇺🇸Dallas, Texas, United States
North Texas Clinical Trials
🇺🇸Fort Worth, Texas, United States
VAST Clinical Research
🇺🇸Garland, Texas, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
DM Clinical Research
🇺🇸Houston, Texas, United States
R and H Clinical Research
🇺🇸Stafford, Texas, United States
Grayline Research Center
🇺🇸Wichita Falls, Texas, United States
Cedar Clinical Research
🇺🇸Draper, Utah, United States
Core Clinical Research
🇺🇸Everett, Washington, United States
Fundacion para el Estudio y Tratamiento de las Enfermedades Mentales
🇦🇷Ciudad Autonoma de Buenos Aires, Argentina
CEN Consultorios Especializados en Neurociencias
🇦🇷Cordoba, Argentina
Instituto Medico DAMIC
🇦🇷Cordoba, Argentina
Centro Medico Luquez
🇦🇷Cordoba, Argentina
Sanatorio Prof Leon S Morra S A
🇦🇷Cordoba, Argentina
INSA Instituto de Neurociencias San AgustÃn
🇦🇷La Plata, Argentina
C I A P Centro de investigacion y Asistencia en Psiquiatria
🇦🇷Rosario, Argentina
Clinica El Jardin
🇦🇷Santiago del Estero, Argentina
L2IP Instituto de Pesquisas Clinicas
🇧🇷Brasilia, Brazil
CAEP Centro Avancado De Estudos E Pesquisas
🇧🇷Campinas, Brazil
Sociedade Literaria e Caritativa Santo Agostinho Hospital Sao Jose
🇧🇷Criciuma, Brazil
Universidade Federal do Rio Grande do Norte Hospital Universitario Onofre Lopes
🇧🇷Natal, Brazil
Instituto Mederi de Pesquisa e Saude
🇧🇷Passo Fundo, Brazil
Hospital De Clinicas De Porto Alegre
🇧🇷Porto Alegre, Brazil
NPCRS Nucleo de Pesquisa Clinica do Rio Grande do Sul
🇧🇷Porto Alegre, Brazil
Uniao Brasileira de Educacao e Assistencia INSCER Instituto do Cerebro do Rio Grande do Sul
🇧🇷Porto Alegre, Brazil
Ruschel Medicina e Pesquisa ClÃnica Ltda
🇧🇷Rio de Janeiro, Brazil
Centro Integrado Facili
🇧🇷Sao Bernardo do Campo, Brazil
CPQuali Pesquisa Clinica LTDA ME
🇧🇷Sao Paulo, Brazil
BR Trials
🇧🇷Sao Paulo, Brazil
UMHAT 'Sveti Georgi'- Plovdiv, Psychiatry Clinic
🇧🇬Plovdiv, Bulgaria
Medical Center St. Naum
🇧🇬Sofia, Bulgaria
Diagnostic Consulting Center Mladost - M Varna
🇧🇬Varna, Bulgaria
Territorial Social Health Authority of the Spedali Civili of Brescia
🇮🇹Brescia, Italy
Azienda Ospedaliero Universitaria Pisana
🇮🇹Pisa, Italy
Health Pharma Professional Research
🇲🇽Mexico city, Mexico
Ketamine Mexico S de RL de C V
🇲🇽Mexico city, Mexico
Gabipros SC
🇲🇽Mexico city, Mexico
Instituto de Informacion e Investigacion en Salud Mental A.C.
🇲🇽Monterrey, Mexico
Centro de Estudios Clinicos y Especialidades Medicas S C
🇲🇽Nuevo Leon, Mexico
Centrum Medyczne Intercor Sp z o o
🇵🇱Bydgoszcz, Poland
PROMENTE Sp. z o.o.
🇵🇱Bydgoszcz, Poland
Centrum Zdrowia Alcea
🇵🇱Gdansk, Poland
Specjalistyczna Praktyka Lekarska Piotr Zalitacz
🇵🇱Gorlice, Poland
NZOZ Euromedica Grudziadz
🇵🇱Grudziadz, Poland
Clinic BBP
🇵🇱Katowice, Poland
Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS
🇵🇱Leszno, Poland
Praktyka Lekarska dr n med Malgorzata Wojtanowska Bogacka
🇵🇱Poznan, Poland
Szpital Nowowiejski Osrodek Badan Klinicznych
🇵🇱Warszawa, Poland
MTZ Clinical Research Powered by Pratia
🇵🇱Warszawa, Poland
Uls Braga - Hosp. Braga
🇵🇹Braga, Portugal
Uls Lisboa Ocidental - Hosp. Egas Moniz
🇵🇹Lisboa, Portugal
Uls Loures Odivelas - Hosp. Loures
🇵🇹Loures, Portugal
Hosp. Divino Espirito Santo Ponta Delgada
🇵🇹Ponta Delgada, Portugal
Hosp. Cuf Porto
🇵🇹Porto, Portugal
Hosp. Central Trofa Saude
🇵🇹Touguinho, Portugal
Spitalul de Psihiatrie si Neurologie Brasov
🇷🇴Brasov, Romania
Spitalul Clinic de Psihiatrie Prof Dr Alexandru Obregia
🇷🇴Bucuresti, Romania
Centrul Medical Melchisedec
🇷🇴Craiova, Romania
CMI Dr. Sarpe Marcel-Claudiu
🇷🇴Focsani, Romania
Spitalul Clinic De Psihiatrie Doctor Gheorghe Preda
🇷🇴Sibiu, Romania
University Clinical Center of Serbia
🇷🇸Belgrade, Serbia
University Clinical Hospital Center Dr Dragisa Misovic- Dedi
🇷🇸Belgrade, Serbia
Specialized Hospital for Psychiatric Diseases Sveti Vracevi
🇷🇸Novi Knezevac, Serbia
Psychiatricka Ambulancia Mentum S.R.O.
🇸🇰Bratislava, Slovakia
Univerzitna nemocnica L. Pasteura Kosice
🇸🇰Kosice, Slovakia
Liptovska Nemocnica S Poliklinikou Mudr. Ivana Stodolu
🇸🇰Liptovsky Mikulas, Slovakia
Psychiatricka Ambulancia Psycholine S.R.O.
🇸🇰Rimavska Sobota, Slovakia
Psychiatricka Ambulancia Centrum Zdravia R.B.K. S.R.O.
🇸🇰Svidnik, Slovakia
Crystal Comfort s.r.o.
🇸🇰Vranov nad Toplou, Slovakia
Institucion Hosp Hestia Palau
🇪🇸Barcelona, Spain
Hosp Clinic de Barcelona
🇪🇸Barcelona, Spain
Hosp Univ Vall D Hebron
🇪🇸Barcelona, Spain
Hosp. Univ. de Basurto
🇪🇸Bilbao, Spain
Hosp. Univ. La Paz
🇪🇸Madrid, Spain
ProbarE i Lund AB
🇸🇪Lund, Sweden
CTC GoCo
🇸🇪Molndal, Sweden
ProbarE i Stockholm AB
🇸🇪Stockholm, Sweden
CTC MTC Uppsala
🇸🇪Uppsala, Sweden
Gulhane Egitim ve Arastirma Hastanesi
🇹🇷Ankara, Turkey
Ankara University Medical Faculty
🇹🇷Ankara, Turkey
Ankara Bilkent Sehir Hastanesi
🇹🇷Ankara, Turkey
Uludag Universitesi Tıp Fakultesi Hastanesi
🇹🇷Bursa, Turkey
Bursa High Speciality Training and Research Dortcelik Mental Hospital
🇹🇷Bursa, Turkey
Gaziantep Universitesi Tip Fakultesi
🇹🇷Gaziantep, Turkey
Erenkoy Mental Hospital
🇹🇷Istanbul, Turkey
Kocaeli University Medical Faculty
🇹🇷Kocaeli, Turkey
Liv Hospital
🇹🇷Samsun, Turkey
Karadeniz Teknik University Medical Faculty
🇹🇷Trabzon, Turkey