VENTURA-2

• Research type

  Research Study

• Full title

  A Randomized, Double-blind, Multicenter, Parallel-Group, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Aticaprant 10 mg as Adjunctive Therapy in Adult Participants with Major Depressive Disorder (MDD) with Moderate-to-Severe Anhedonia and Inadequate Response to Current Antidepressant Therapy.

• IRAS ID

  1006932

• Contact name

  David Wright

• Contact email

  prderacta@prdgb.jnj.com

• Sponsor organisation

  Janssen-Cilag International NV

• Eudract number

  2022-000461-41

• Research summary

  This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the effectiveness, safety and tolerability of aticaprant 10mg as an add on treatment in adult patients with Major Depressive Disorder (MDD) with Moderate-to-severe Anhedonia and Inadequate Response to Current Antidepressant Therapy.

  This study will consist of the following phases:
  -Screening Phase (evaluate eligibility): up to 30 days prior to first dose administration.
  -Double-blind (DB) Treatment Phase: 43 days.
  -Follow-up Phase: up to 14 days.

  Participants will be randomised in a 1:1 ratio to receive aticaprant 10 mg or placebo for 42 days. The study intervention will be administered orally as 2 film-coated tablets to be taken together, once daily, around the same time and preferably in the morning. Approximately 538 participants a , including adult (18 to 64 years of age, inclusive) and elderly (65 to 74 years of age, inclusive) will be enrolled in this study. This includes approximately 324 adult participants with MDD ANH+, 106 adult participants with MDD ANH-, and 108 elderly participants with
  MDD ANH+/MDD ANH-) that will be enrolled in this study.

  The change in the MADRS total score from baseline (ie, Day 1, pre-randomisation, and hereafter referred to as 'baseline') to Day 43 (ie, at the end of the double-blind [DB] Treatment Phase) in participants with MDD ANH+, as assessed using the Structured Interview Guide for the MADRS [SIGMA]), will be utilised for primary assessment of efficacy.

• REC name

  Yorkshire & The Humber - Leeds East Research Ethics Committee

• REC reference

  23/YH/0024

• Date of REC Opinion

  6 Sep 2023

• REC opinion

  Further Information Favourable Opinion