An Open-label, Long-term, Safety and Efficacy Study of Aticaprant as Adjunctive Therapy in Adult and Elderly Participants With Major Depressive Disorder (MDD)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-508163-74-00

Acronym

67953964MDD3003

Enrollment

356

Registered

2024-10-03

Start date

2023-06-12

Completion date

2025-02-28

Last updated

2024-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder

Brief summary

AEs including AEs of special interest (AESI), Change from baseline in vital signs, Weight/body mass index (BMI), Suicidality assessment using the Columbia Suicidality Severity Rating Scale (C-SSRS), Laboratory parameters, 12-lead ECG, Assessment of withdrawal symptoms using the Physician Withdrawal Checklist, 20-item (PWC-20)., Proportion of participants with clinically relevant sexual dysfunction over time in the Arizona Sexual Experiences Scale (ASEX) score.

Interventions

DRUGJNJ-67953964

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
AEs including AEs of special interest (AESI), Change from baseline in vital signs, Weight/body mass index (BMI), Suicidality assessment using the Columbia Suicidality Severity Rating Scale (C-SSRS), Laboratory parameters, 12-lead ECG, Assessment of withdrawal symptoms using the Physician Withdrawal Checklist, 20-item (PWC-20)., Proportion of participants with clinically relevant sexual dysfunction over time in the Arizona Sexual Experiences Scale (ASEX) score.	—

Measure

Time frame

—

Countries

Belgium, Bulgaria, Czechia, France, Hungary, Italy, Poland, Portugal, Slovakia, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026