Last updated 16 days ago
A Study of Aticaprant in Adult and Elderly Participants With Major Depressive Disorder (MDD)
840 patients around the world
Available in Argentina, Mexico, United States, Brazil, Spain
Janssen Research & Development, LLC
45Research sites
840Patients around the world
This study is for people with
Depression
Major depression
Requirements for the patient
To 74 Years
All Gender
Medical requirements
- Transferred-entry participants: Participants must have completed the double blind (DB) (expand DB) Treatment Phase of Study 67953964MDD3001 or Study 67953964MDD3002 without early treatment discontinuation or switch in the oral selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor (SSRI/SNRI) in the parent studyDirect-entry participants: Have a Hamilton Depression Rating Scale (HDRS)-17 total score of 20 or higher at the first and second screening interviews and must not demonstrate a clinically significant improvement (that is, an improvement of more than 20 percent (%) on their HDRS-17 total score) between the first and the second independent HDRS-17 assessmentsDirect-entry participants: Have had an inadequate response to at least 1 oral antidepressant treatment, administered at an adequate dose (at or above the minimum therapeutic dose per Massachusetts general hospital antidepressant treatment response questionnaire [MGH ATRQ]) and duration (at least 6 weeks) in the current episode of depressionDirect-entry participants: Must be an outpatient at open-label treatment phase baselineDirect-entry participants: Meet Diagnostic and Statistical Manual of Mental Disorders-5th Edition (DSM-5) diagnostic criteria for recurrent or single episode major depressive disorder (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)Direct-entry and Transferred-entry Participants: Participants should not take any prohibited medication or food supplements
- Transferred-entry Participants: Participant has been non-compliant with the study intervention administration in the DB Treatment Phase in either of Studies 67953964MDD3001 or 67953964MDD3002 (that is, have missed either 4 or more consecutive doses of study intervention or a total of 8 or more doses during the DB Treatment Phase)Transferred-entry Participants: Participant has any condition or situation/circumstance for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise the well-being) or that could prevent, limit, or confound the protocol specified assessmentsDirect-entry Participants: Employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigatorDirect-entry Participants: Has a history or evidence of clinically meaningful noncompliance with current antidepressant therapyDirect-entry Participants: Known allergies, hypersensitivity, or intolerance to aticaprant or any of its excipients
Sites
Instituto Médico Damic S.R.L.
Instituto Modelo de Neurología Lennox
Recruiting
STAT Research - CABA
CIPREC Centro de Investigación y Prevención Cardiovascular - CABA
CENYDET Centro Neurobiológico y de Estrés Traumático (Biopsychomedical Research Group S.R.L.)
Instituto Privado Kremer
Centro Médico Luquez
Sanatorio Privado Prof. Leon S Morra S.A.
Clínica Privada de Salud Mental Santa Teresa de Ávila
Centro de Investigación y Asistencia en Psiquiatría - CIAP
StudyVENTURA-LT
SponsorJanssen Research & Development, LLC
Study typeInterventional
Conditions
Major depression
Requirements
To 74 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05518149
