TerminatedPhase 3

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

Stopped: The study was Early Terminated as per Sponsor's decision (communicated to sites on 06Mar2025)

United States, Argentina, Australia871 participantsStarted 2022-09-22

Plain-language summary

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).

Who can participate

Age range

18 Years – 74 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

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
Participants should not take any prohibited medication or food supplements

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants with Adverse Events (AEs)

Timeframe: Up to Week 54

Number of Participants with Adverse Events of Special Interest (AESI)

Timeframe: Up to Week 54

Number of Participants with Change from Baseline in Vital Signs Abnormalities

Timeframe: Up to Week 54

Number of Participants with Abnormal Body Weight

Timeframe: Up to Week 54

Number of Participants with Abnormal Body Mass Index (BMI)

Timeframe: Up to Week 54

Percentage of Participants with Suicidal Ideation or Suicidal Behavior based on the Columbia-Suicide Severity Rating Scale (C-SSRS)

Timeframe: Up to Week 54

Number of Participants with Abnormalities in Clinical Laboratory parameters

Timeframe: Up to Week 54

Trial details

NCT IDNCT05518149

SponsorJanssen Research & Development, LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-04-25

View on ClinicalTrials.gov More Depressive Disorder, Major trials

Plain-language summary

Who can participate

Age range

18 Years – 74 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

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
Participants should not take any prohibited medication or food supplements

What they're measuring

Number of Participants with Adverse Events (AEs)

Timeframe: Up to Week 54

Number of Participants with Adverse Events of Special Interest (AESI)

Timeframe: Up to Week 54

Number of Participants with Change from Baseline in Vital Signs Abnormalities

Timeframe: Up to Week 54

Number of Participants with Abnormal Body Weight

Timeframe: Up to Week 54

Number of Participants with Abnormal Body Mass Index (BMI)

Timeframe: Up to Week 54

Percentage of Participants with Suicidal Ideation or Suicidal Behavior based on the Columbia-Suicide Severity Rating Scale (C-SSRS)

Timeframe: Up to Week 54

Number of Participants with Abnormalities in Clinical Laboratory parameters

Timeframe: Up to Week 54