Ventura- LT
Research type
Research Study
Full title
An Open-label, Long-term, Safety and Efficacy Study of Aticaprant as Adjunctive Therapy in Adult and Elderly Participants With Major Depressive Disorder (MDD)
IRAS ID
1007073
Contact name
David Wright
Contact email
Sponsor organisation
Janssen-Cilag International NV
Eudract number
2022-000430-42
Clinicaltrials.gov Identifier
Research summary
This is an open-label (OL), multicenter, long-term study to evaluate the safety, tolerability and efficacy of aticaprant 10mg in combination with an oral antidepressant in adult and elderly participants (18 to 74 years, inclusive) who have MDD and particularly in those with MDD with moderate-to-severe anhedonia (ANH+), who have had an inadequate response to an SSRI or an SNRI in the current depressive episode. The safety, tolerability, and efficacy of aticaprant has been studied so far in short-term studies (up to 8weeks). Therefore, the benefit-risk profile of adjunctive aticaprant therapy with longer treatment has not been established. Aticaprant was generally well tolerated in healthy participants after single dose administration up to 60 mg or after multiple-dose administration up to 35 mg for 14 days, with no clinically significant AEs, vital sign measurements, 12-lead ECGs, or clinical laboratory evaluations reported. Taking into account the measures taken to minimise risk to participants of this study, the potential risks identified in association with aticaprant are justified by the anticipated benefits that may be afforded to participants; this supports further clinical investigation of adjunctive treatment with aticaprant.
Transferred entry participants from the main study 67953964MDD3002 will be enroled in this study. Additionally, participants may be enroled directly into the study to meet the target of achieving the required number of participants with 6 months and 1 year of exposure to aticaprant.
This study will consist of 3 phases:
• Screening Phase (evaluate eligibility in direct-entry participants only): up to 30 days prior to the first dose administration. Transferred-entry participants will enter directly into the OL Treatment Phase,
• OL Treatment Phase: 52 weeks (both direct- and transferred- entry),
• Follow-up Phase: up to 14 days (both direct- and transferred- entry).REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
23/YH/0058
Date of REC Opinion
23 Oct 2023
REC opinion
Further Information Favourable Opinion