NCT05518149
Who may be able to join
Who might be able to join this trial:
If you are joining from a previous related study (transferred-entry):
- You must have fully completed the treatment phase of one of two specific earlier studies (67953964MDD3001 or 67953964MDD3002) without stopping early or changing your antidepressant medication during that study
If you are joining this trial fresh (direct-entry):
- You must score 20 or higher on a standard depression rating scale (called the HDRS-17) at two separate screening appointments, and your scores must not have improved by more than 20% between those two appointments
- Your current episode of depression must not have improved enough with at least one antidepressant medication that you took at a proper dose for at least 6 weeks
- You must be living at home (not in a hospital or inpatient facility) at the start of the treatment phase
- You must have been diagnosed with major depressive disorder (MDD) — either a single or recurring episode, without psychosis — confirmed through a structured clinical interview
For everyone:
- You must not be taking any medications or food supplements that are not allowed by the trial
Who may not be able to join:
If joining from a previous related study (transferred-entry):
- You missed 4 or more doses of study medication in a row, or missed 8 or more doses in total during the earlier study
- The trial doctor believes that taking part would not be in your best interest or could affect your health or the accuracy of the study results
If joining fresh (direct-entry):
- You are an employee or family member of an employee working at the clinic or research site running this trial
- You have a history of not following your current antidepressant treatment as prescribed in a meaningful way
- You have a known allergy or sensitivity to the study drug (aticaprant) or any of its ingredients
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Trial details
Where this trial is recruiting
3 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Number of Participants with Adverse Events (AEs); Number of Participants with Adverse Events of Special Interest (AESI); Number of Participants with Change from Baseline in Vital Signs Abnormalities; Number of Participants with Abnormal Body Weight; Number of Participants with Abnormal Body Mass Index (BMI); Percentage of Participants with Suicidal Ideation or Suicidal Behavior based on the Columbia-Suicide Severity Rating Scale (C-SSRS); Number of Participants with Abnormalities in Clinical Laboratory parameters; Number of Participants with Abnormalities in Electrocardiogram (ECG); Withdrawal...
Can't join this trial?
Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.