A Study of Aticaprant in Adult and Elderly Participants W... | NCT05518149

NCT05518149

ID	Type	Description
67953964MDD3003	Other Identifier	Janssen Research & Development, LLC
2022-000430-42	EudraCT Number
2023-508163-74-00	Registry Identifier	EUCT number

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Aticaprant 10 mg	Experimental	Participants will enter this study directly or after completing double-blind phase of studies 67953964MDD3001 or 67953964MDD3002 and will receive Aticaprant 10 milligrams (mg), once daily, orally in addition to the current antidepressant selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor (SSRI/SNRI) therapy on Day 1 up to 52 weeks.	Drug: Aticaprant

Name	Type	Description	Arm Group Labels	Other Names
Aticaprant	Drug	Aticaprant 10 mg tablet will be administered orally.	Aticaprant 10 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants with Adverse Events (AEs)	An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have causal relationship with the intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product.	Up to Week 54
Number of Participants with Adverse Events of Special Interest (AESI)	AEs considered to be of special interest are as Pruritus and Diarrhea.	Up to Week 54
Number of Participants with Change from Baseline in Vital Signs Abnormalities	Vital signs include body weight, temperature, pulse/heart rate, respiratory rate, pulse oximetry and blood pressure (systolic and diastolic) values.	Up to Week 54
Number of Participants with Abnormal Body Weight	Participants will be weighed at approximately the same time of day on the same scale, wearing lightweight clothing without shoes; they will be instructed to empty their bladders before being weighed.	Up to Week 54
Number of Participants with Abnormal Body Mass Index (BMI)	A BMI between 18.5 and 25 kilogram per meter square (kg/m^2) indicates a normal weight.	Up to Week 54
Percentage of Participants with Suicidal Ideation or Suicidal Behavior based on the Columbia-Suicide Severity Rating Scale (C-SSRS)

Secondary Outcomes

Measure	Description	Time Frame
Change from Baseline in the Montgomery-asberg Depression Rating Scale (MADRS) Total Score Over Time	Change from baseline in MADRS total score over time will be reported. The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The scale consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total score of 60. Higher scores represent a more severe condition.

Eligibility Module

Eligibility 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:

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

Exclusion Criteria:

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

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Apr 22, 2026			May 13, 2026	39
Jun 3, 2026			Jun 26, 2026	40

ID	Term
D003866	Depressive Disorder
D019964	Mood Disorders
D001523	Mental Disorders