Last updated 15 days ago
A Study of Aticaprant Plus an Antidepressant to Prevent Return of Depression Symptoms in Participants With Major Depressive Disorder Who Experience a Loss of Interest and Pleasure
660 patients around the world
Available in Argentina, Mexico
Janssen Research & Development, LLC
5Research sites
660Patients around the world
This study is for people with
Depression
Major depression
Requirements for the patient
To 64 Years
All Gender
Medical requirements
- Be medically stable based on physical examination including a brief neurologic examination, medical history, vital signs including blood pressure, and 12-lead electrocardiogram ECG performed at screening and OL baseline.Be medically stable based on clinical laboratory tests performed at screening.Meet DSM-5 diagnostic criteria for recurrent or single episode MDD, without psychotic features upon clinical assessment and confirmed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders-5th Edition DSM-5 Axis I Disorders-Clinical Trials version SCID-CT.Have symptoms of anhedonia based on clinical assessment and confirmed by presence of anhedonia positive response to major depressive episode MDE module symptom Item 2 on the SCID-CT at screening.
- Has had no response to 2 or more consecutive antidepressant treatments administered at adequate dose and duration in the current episode of depression including the current selective SSRI/SNRI assessed using the Massachusetts General Hospital Antidepressant Treatment Response Questionnaire MGH ATRQ.Has a history or evidence of clinically meaningful noncompliance with current antidepressant therapy.Has a history of moderate-to-severe substance use disorder including alcohol use disorder according to DSM-5 criteria within 6 months before screening.Has homicidal ideation/intent, per the investigator's clinical judgment, or has suicidal ideation with some intent to act within 3 months prior to the start of the screening phase.Has cognitive impairment per investigator judgment that would render the informed consent invalid or limit the ability of the participant to comply with the study requirements.
Sites
Instituto Modelo de Neurología Lennox
Recruiting
Hospital Italiano de Buenos Aires - CABA, Buenos Aires
Recruiting
CIT-Neuropsique S.C.
Recruiting
Hospital Aranda de la Parra S.A. de C.V.
Recruiting
Human Science Research Trials
Recruiting
StudyVENTURA-5
SponsorJanssen Research & Development, LLC
Conditions
Major depression
Requirements
To 64 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06635135
