Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Janssen Research & Development, LLC
Age
18–74
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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 study
Direct-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 assessments
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 depression
Must be an outpatient at open-label treatment phase baseline
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
You may not be if
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)
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 assessments
Direct-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 investigator
Has a history or evidence of clinically meaningful noncompliance with current antidepressant therapy
Known allergies, hypersensitivity, or intolerance to aticaprant or any of its excipients
Clareo Health | A Study of Aticaprant in Adult and Elderly Participants With Major Depressive Disorder (MDD)
