For Healthcare Professionals

A Study of Aticaprant in Adult and Elderly Participants With Major Depressive Disorder (MDD)

clipboard-pencil

About the study

The purpose of this study is to assess the long-term safety and tolerability of aticaprant administered as adjunctive therapy to a current antidepressant (selective serotonin reuptake inhibitor \[SSRI\] or serotonin and norepinephrine reuptake inhibitor \[SNRI\]) in all participants with major depressive disorder (MDD).
user-3

Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:


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:


  1. 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
  2. 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
  3. Must be an outpatient at open-label treatment phase baseline
  4. 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


EXCLUSION CRITERIA

Exclusion Criteria:


Transferred-entry Participants:


  1. 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)
  2. 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:


  1. 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
  2. Has a history or evidence of clinically meaningful noncompliance with current antidepressant therapy
  3. Known allergies, hypersensitivity, or intolerance to aticaprant or any of its excipients

pin location

Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 844-434-4210Email iconEmail Study Center

Study Details


Contition

Depressive Disorder, Major

Age

18 - 74

Phase

PHASE3

Participants Needed

840

Est. Completion Date

Dec 15, 2025

Treatment Type

INTERVENTIONAL


Sponsor

Janssen Research & Development, LLC

ClinicalTrials.gov NCT Identifier

NCT05518149

Study Number

67953964MDD3003

Understanding Clinical Trials


Get answers to your questions about clinical trials.What is clinical research?What does taking part in clinical trials involve?What should I ask the trial doctor?
Vector

Interested?

Sign up to create a personal profile and 
receive news, resources, and alerts 
about clinical trials related to your conditions of interest.