Last updated 10 days ago
A Study to Evaluate the Efficacy and Safety of Esketamine for Reduction of Symptoms of Major Depressive Disorder
258 patients around the world
Available in United States, Brazil
Janssen Research & Development, LLC
2Research sites
258Patients around the world
This study is for people with
Depression
Major depression
Requirements for the patient
To 17 Years
All Gender
Medical requirements
- Must meet diagnostic and statistical manual of mental disorders (5th edition) (DSM-5) diagnostic criteria for major depressive disorder (MDD) based upon clinical assessment and confirmed by the mini-international neuropsychiatric interview for children and adolescents (MINI-KID).Must have a clinical global impression - severity of suicidality - revised (CGI-SS-R) score of 'Markedly' or greater (that is, greater than or equal to [>=] 4) at both screening and baseline (predose) visits.Must have a children's depression rating scale - revised (CDRS-R) total score >= 58 at baseline (predose).In the physician's opinion, acute psychiatric hospitalization is clinically warranted due to subject's acute suicidality.Must be medically stable based on physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening.
- Participant has a current DSM-5 diagnosis of bipolar (or related disorders), intellectual disability, autism spectrum disorder, conduct disorder, oppositional defiant disorder.Participant currently meets DSM-5 criteria for borderline personality disorder.Participant has a current or prior DSM-5 diagnosis of a psychotic disorder, or MDD with psychosis.Participant has a history of seizure disorder.Participant has known allergies, hypersensitivity, intolerance or contraindications to midazolam, esketamine or ketamine, or their excipients.
Sites
Facili Centro Integrado de Saúde Mental
Recruiting
Instituto APICE – Ciência e Pesquisa em Saúde Mental
Recruiting
StudyAVENUE
SponsorJanssen Research & Development, LLC
Study typeInterventional
Conditions
Major depression
Requirements
To 17 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07227454
