A Study of Seltorexant as Monotherapy in Adults and Elderly Participants With Major Depressive Disorder
27 de agosto de 2026 actualizado por: Janssen Research & Development, LLC
A Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate Efficacy and Safety of Seltorexant as Monotherapy in Adult and Elderly Participants With Major Depressive Disorder (MDD) and an Open-label Long-term Extension Treatment With Seltorexant
The main purpose of this study is to assess how well the study drug (JNJ-42847922) works (efficacy) compared with placebo in improving depressive symptoms in participants with major depressive disorder ([MDD], a common mood disorder that causes a lasting feeling of sadness and a loss of interest in everyday activities) in double-blind treatment phase.
Further, to evaluate long-term safety and tolerability of JNJ-42847922 in participants with MDD in the open label treatment phase.
Descripción general del estudio
Estado
Estado
Reclutamiento
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Tipo de estudio
Tipo de estudio
Intervencionista
Inscripción (Estimado)
Inscripción
600
Fase
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
Estudio Contacto
- Nombre: Study Contact
- Número de teléfono: 844-434-4210
- Correo electrónico: Participate-In-This-Study1@its.jnj.com
Ubicaciones de estudio
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São Bernardo do Campo, Brasil, 09726 150
- Reclutamiento
- Centro Integrado Facili
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São Paulo, Brasil, 01236030
- Reclutamiento
- BR Trials
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British Columbia
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North Vancouver, British Columbia, Canadá, V7P2T4
- Reclutamiento
- Medical Arts Research Health Group
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Arkansas
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Bryant, Arkansas, Estados Unidos, 72022
- Reclutamiento
- SanRo Clinical Research Group LLC WCG Clinical Network
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California
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Bellflower, California, Estados Unidos, 90706
- Reclutamiento
- CI Trials
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Glendale, California, Estados Unidos, 91206
- Reclutamiento
- Behavioral Research Specialists LLC
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Oceanside, California, Estados Unidos, 92056
- Reclutamiento
- Excell Research Inc
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Orange, California, Estados Unidos, 92868
- Reclutamiento
- NRC Research Institute
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Riverside, California, Estados Unidos, 92506
- Reclutamiento
- CenExel
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Walnut Creek, California, Estados Unidos, 94596
- Reclutamiento
- Sunwise Clinical Research
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Florida
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Doral, Florida, Estados Unidos, 33178
- Reclutamiento
- UHC Research
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Hialeah, Florida, Estados Unidos, 33012
- Reclutamiento
- Reliable Clinical Research
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Miami, Florida, Estados Unidos, 33186
- Reclutamiento
- Nuovida Research Center
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Tampa, Florida, Estados Unidos, 33629
- Reclutamiento
- IPTB Clinical Research
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West Palm Beach, Florida, Estados Unidos, 33407
- Reclutamiento
- Health Synergy Clinical Research
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Georgia
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Atlanta, Georgia, Estados Unidos, 30328
- Reclutamiento
- Agile Clinical Research Trials, LLC
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Snellville, Georgia, Estados Unidos, 30078
- Reclutamiento
- Accelerated Clinical Research Group LLC
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Illinois
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Chicago, Illinois, Estados Unidos, 60634
- Reclutamiento
- Chicago Research Center
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Maryland
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Baltimore, Maryland, Estados Unidos, 21208
- Reclutamiento
- Pharmasite Research, Inc.
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02116
- Reclutamiento
- Adams Clinical Boston
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Watertown, Massachusetts, Estados Unidos, 02472
- Reclutamiento
- Adams Clinical Watertown
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New Jersey
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Marlton, New Jersey, Estados Unidos, 08053
- Reclutamiento
- CenExel Marlton NJ
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New York
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Brooklyn, New York, Estados Unidos, 11235
- Reclutamiento
- SPRI Clinical Trials, LLC
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Brooklyn, New York, Estados Unidos, 11229
- Reclutamiento
- Integrative Clinical Trials LLC
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Mount Kisco, New York, Estados Unidos, 10549
- Reclutamiento
- Bioscience Research LLC
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New York, New York, Estados Unidos, 10036
- Reclutamiento
- Manhattan Behavioral Medicine
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New York, New York, Estados Unidos, 10017
- Reclutamiento
- Fieve Clinical Research Inc
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New York, New York, Estados Unidos, 10029
- Reclutamiento
- Adams Clinical Harlem
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North Carolina
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Cary, North Carolina, Estados Unidos, 27511
- Reclutamiento
- Magnolia Clinical Research LLC
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Ohio
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Cincinnati, Ohio, Estados Unidos, 45215
- Reclutamiento
- Patient Priority Clinical Sites LLC
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Oklahoma
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Edmond, Oklahoma, Estados Unidos, 73013
- Reclutamiento
- Conrad Clinical Research
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Oklahoma City, Oklahoma, Estados Unidos, 73116
- Reclutamiento
- Sooner Clinical Research
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Utah
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Clinton, Utah, Estados Unidos, 84015
- Reclutamiento
- Alpine Research Organization
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Washington
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Bellevue, Washington, Estados Unidos, 98007
- Reclutamiento
- Northwest Clinical Research Center
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Kuala Lumpur, Malasia, 59100
- Reclutamiento
- University Malaya Medical Centre
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Taichung, Taiwán, 402
- Reclutamiento
- Chung Shan Medical University Hospital
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Taipei, Taiwán, 112
- Reclutamiento
- Taipei Veterans General Hospital
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Taipei, Taiwán, 110
- Reclutamiento
- Taipei Medical University Hospital
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Taipei, Taiwán, 10449
- Reclutamiento
- Taipei Mackay Memorial Hospital
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion criteria:
- Meet diagnostic and statistical manual of mental disorders-5th edition (DSM-5) diagnostic criteria for major depressive disorder (MDD), without psychotic features based upon clinical assessment
- Experienced at least one MDD episode prior to their current episode
- Current episode of MDD must be a minimum of 2 weeks in duration
Must meet one of the following criteria regarding current medication status.
Can be presenting for a new episode of MDD on no antidepressant treatment; however, must have been treated with an antidepressant medication in a prior episode for a minimum of 6 weeks at a stable dose at or above the minimum therapeutic level (medical record/source document).
OR
- Have taken up to two antidepressant treatments started in the current episode that were stopped (withdrawn), or will be withdrawn (washed out) due to inadequate response or intolerance.
- Body Mass Index (BMI) between 18 and 40 kilograms per square meter (kg/m^2)
- Must be medically stable on the basis of the following performed at screening and double-blind (DB) baseline: physical examination (including a brief neurological examination), vital signs (including blood pressure), and 12-lead electrocardiogram (ECG)
Exclusion criteria:
- Use of ketamine/esketamine in the current depressive episode (up to 2 doses are allowed prior to screening)
- Has treatment-resistant depression (TRD)
- Has a primary DSM-5 diagnosis of panic disorder, generalized anxiety disorder, social anxiety disorder, or specific phobia which has been the primary focus of psychiatric treatment within the past 2 years
- Current active DSM-5 diagnosis of obsessive-compulsive disorder, posttraumatic stress disorder, anorexia nervosa, bulimia nervosa, or fibromyalgia
- Has a history or current diagnosis of a psychotic disorder, bipolar disorder, autism spectrum disorder, borderline personality disorder, or somatoform disorders
- Has dementia, any dementing disease, intellectual disability, or neurocognitive disorder
- Has a current or recent history of homicidal ideation or serious suicidal ideation within the past 3 months or a history of suicidal behavior within the past 6 months
- Has a history of moderate-to-severe substance use disorder including alcohol use disorder according to DSM-5 criteria within 6 months
- Has any significant sleep disorder, including but not limited to untreated/uncontrolled conditions
- Has known allergies, hypersensitivity, intolerance, or any contraindication to seltorexant or its excipients
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Número de brazos
2
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
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Experimental: Seltorexant
Participants will receive seltorexant tablet orally once daily, from Day 1 to Day 42 in double blind (DB) treatment phase.
Eligible participants who will enter the open label (OL) treatment phase will receive seltorexant tablet daily from OL baseline until the end of phase/ early withdrawal (EW) visit (up to 6 months).
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Seltorexant tablet will be administered orally.
Otros nombres:
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Comparador de placebos: Placebo
Participants will receive matching placebo tablet orally once daily from Day 1 to Day 42 in double-blind treatment phase.
Eligible participants who will enter the OL treatment phase will receive seltorexant tablet daily from OL baseline until the end of phase/ EW visit (up to 6 months).
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La tableta de placebo se administrará por vía oral.
Seltorexant tablet will be administered orally.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Double Blind (DB) Treatment Phase: Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score in Participants with Major Depressive Disorder with Moderate-to-Severe Insomnia Symptoms (MDDIS)
Periodo de tiempo: Baseline up to Day 43
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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.
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Baseline up to Day 43
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Open-Label (OL) Treatment Phase: Number of Participants with Adverse Events Including Adverse Event of Special Interests (AESIs)
Periodo de tiempo: OL Baseline (Day 43) Up to 6 months
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An AE is any untoward medical occurrence in a clinical study participant administered with a pharmaceutical (investigational or non investigational) product.
An AE does not necessarily have a causal relationship with the intervention.
The following AESIs are considered in this study: Suicidal thoughts, suicidal ideation, and suicidal behavior; Cataplexy; Sleep paralysis; Complex, sleep-related behaviors/parasomnias; Fall and Motor vehicle accident.
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OL Baseline (Day 43) Up to 6 months
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OL Treatment Phase: Number of Participants with Vital Signs Abnormalities
Periodo de tiempo: OL Baseline (Day 43) Up to 6 months
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Number of participants with vital signs (blood pressure and pulse/heart rate measurements) abnormalities will be reported.
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OL Baseline (Day 43) Up to 6 months
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OL Treatment Phase: Number of Participants with Suicidality Assessment using Columbia-Suicide Severity Rating Scale (C-SSRS)
Periodo de tiempo: OL Baseline (Day 43) Up to 6 months
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The C-SSRS is a low-burden measure of the spectrum of suicidal ideation and behavior that was developed to assess severity and track suicidal events through any treatment.
The C-SSRS scale consists of 28 items in 4 sections: suicide behavior, actual attempts, suicidal ideation, and intensity of ideation.
Suicidal ideation consists of 5 'yes/no' items: wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods (not plan) without intention to act, active suicidal ideation with some intent to act without specific plan, active suicidal ideation with specific plan and intent.
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OL Baseline (Day 43) Up to 6 months
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OL Treatment Phase: Number of Participants with Withdrawal Symptoms Assessment Using Physician Withdrawal Checklist (PWC-20)
Periodo de tiempo: End of Treatment/Early withdrawal to end of the Follow-up visit (up to 14 days)
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Potential withdrawal effects will be assessed by the PWC-20.
The PWC-20 is a simple and accurate method used to assess potential withdrawal symptoms following cessation of treatment.
The PWC-20 is a reliable and sensitive instrument for the assessment of discontinuation symptoms.
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End of Treatment/Early withdrawal to end of the Follow-up visit (up to 14 days)
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OL Treatment Phase: Number of Participants with Abnormalities in Electrocardiogram (ECG)
Periodo de tiempo: OL Baseline (Day 43) up to 6 months
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Number of participants with abnormalities in ECG will be reported.
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OL Baseline (Day 43) up to 6 months
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OL Treatment Phase: Number of Participants Reporting Sexual Functioning using Arizona Sexual Experiences Scale (ASEX)
Periodo de tiempo: Up to 6 months
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The ASEX is a patient-reported 5-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm.
Possible total scores range from 5 to 30, with the higher scores indicating more sexual dysfunction.
The scale has shown satisfactory reliability and validity.
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Up to 6 months
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OL Treatment Phase: Change from Baseline in the Body Weight
Periodo de tiempo: OL Baseline (Day 43) up to 6 months
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Change from baseline in body weight will be reported.
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OL Baseline (Day 43) up to 6 months
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OL Treatment Phase: Change from Baseline in the Body Mass Index (BMI)
Periodo de tiempo: OL Baseline (Day 43) up to 6 months
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Change from baseline in BMI will be reported.
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OL Baseline (Day 43) up to 6 months
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OL Treatment Phase: Change from Baseline in the Waist Circumference
Periodo de tiempo: OL Baseline (Day 43) up to 6 months
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Change from baseline in waist circumference will be reported.
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OL Baseline (Day 43) up to 6 months
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OL Treatment Phase: Number of Participants with Abnormalities in Clinical Laboratory Parameters
Periodo de tiempo: OL Baseline (Day 43) up to 6 months
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Number of participants with laboratory abnormalities related to hematology, serum chemistry will be reported.
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OL Baseline (Day 43) up to 6 months
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Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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DB Treatment Phase: Change from Baseline in MADRS-Without Sleep Item (WOSI) Total Score
Periodo de tiempo: Baseline up to Day 43
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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.
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Baseline up to Day 43
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DB Treatment Phase: Change from Baseline in Sleep Disturbance using Patient Reported Outcome Measurement Information System-Sleep Disturbance (PROMIS-SD) Short Form 10a(8a + 2a ) T-score
Periodo de tiempo: Baseline up to Day 43
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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.
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Baseline up to Day 43
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DB Treatment phase: Change from Baseline in MADRS-6 Total Score
Periodo de tiempo: Baseline up to Day 43
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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).
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Baseline up to Day 43
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DB Treatment Phase: Proportion of Participants with Response on Depressive Symptoms Scale
Periodo de tiempo: Baseline up to Day 43
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Responders are defined as proportion of participants with greater than or equal to (>=) 50 percent (%) improvement in the MADRS total score from baseline to Day 43.
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Baseline up to Day 43
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DB Treatment Phase: Change from Baseline in Sleep Disturbance using PROMIS-SD Short Form 8a T-Score
Periodo de tiempo: Baseline up to Day 43
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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.
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Baseline up to Day 43
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DB Treatment Phase: Change from Baseline in Patient Health Questionnaire 9-Item (PHQ-9) Total Score
Periodo de tiempo: Baseline up to Day 43
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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.
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Baseline up to Day 43
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DB Period: Change from Baseline in Work Productivity and Activity Impairment Questionnaire, Depression (WPAI-D) Scores
Periodo de tiempo: Baseline up to Day 43
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The WPAI-D questionnaire is a patient-reported instrument to measure impairments in both paid work and unpaid work.
It measures absenteeism, presenteeism as well as the impairments in unpaid activity because of health problems during the past 7 days.
The WPAI yields four types of scores: (a) Absenteeism (work time missed); (b) Presenteeism (impairment at work / reduced on-the-job effectiveness); (c) Work productivity loss (overall work impairment / absenteeism plus presenteeism); (d) Activity Impairment.
The first three scores are derived only for respondents who were working (should be missing for non-working), but the last score is applicable for all respondents.
Each score ranges from 0 to 100 with higher scores indicating greater impairment and less productivity.
Negative changes in score indicates less impairment and greater productivity.
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Baseline up to Day 43
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OL Treatment Phase: Change from Baseline Over Time in MADRS Total Score
Periodo de tiempo: OL Baseline (Day 43) up to 6 months
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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.
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OL Baseline (Day 43) up to 6 months
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OL Treatment Phase: Change from Baseline Over Time in Clinical Global Impression-Severity (CGI-S) Score
Periodo de tiempo: OL Baseline (Day 43) up to 6 months
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The CGI-S provides an overall clinician-determined summary measure of the severity of the participant's illness that takes into account all available information, including knowledge of the participant's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the participant's ability to function.
The CGI-S evaluates the severity of psychopathology on a scale of 1 to 7. Considering total clinical experience with the depression population, a participant is assessed on severity of illness at the time of rating according to the following criteria: 1=normal (not at all ill); 2=borderline ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients.
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OL Baseline (Day 43) up to 6 months
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OL Treatment Phase: Change from Baseline Over Time in MADRS-WOSI Total Score
Periodo de tiempo: OL Baseline (Day 43) up to 6 months
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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.
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OL Baseline (Day 43) up to 6 months
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OL Treatment Phase: Change from Baseline Over Time in Sleep Disturbance using PROMIS-SD Short Form 10a(8a+2a) T-score
Periodo de tiempo: OL Baseline (Day 43) up to 6 months
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The PROMIS-SD 10a(8a+2a) 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 10a(8a+2a) 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.
|
OL Baseline (Day 43) up to 6 months
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OL Treatment Phase: Change from Baseline in Work Productivity and Activity Impairment-Questionnaire Depression (WPAI-D) Score
Periodo de tiempo: OL Baseline (Day 43) up to 6 months
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The WPAI-D questionnaire is a validated short instrument that assesses impairment in work and other regular activities over the past 7 days.
The WPAI yields four types of scores: (a) Absenteeism (work time missed); (b) Presenteeism (impairment at work / reduced on-the-job effectiveness); (c) Work productivity loss (overall work impairment / absenteeism plus presenteeism); (d) Activity Impairment.
The first three scores are derived only for respondents who were working (should be missing for non-working), but the last score is applicable for all respondents.
Each score ranges from 0 to 100 with higher scores indicating greater impairment and less productivity.
Negative changes in score indicates less impairment and greater productivity.
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OL Baseline (Day 43) up to 6 months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Patrocinador
Investigadores
Investigadores
- Director de estudio: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
Inicio del estudio
30 de abril de 2026
Finalización primaria (Estimado)
Finalización primaria
24 de agosto de 2028
Finalización del estudio (Estimado)
Finalización del estudio
3 de mayo de 2029
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
1 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
1 de mayo de 2026
Publicado por primera vez (Actual)
Publicado por primera vez
7 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
28 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
27 de agosto de 2026
Última verificación
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
Otros números de identificación del estudio
- 42847922MDD3011 (Otro identificador: Janssen Research & Development, LLC)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
The data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency.
As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
Sí
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .