Trial intelligence / Profile preview

Aticaprant as Adjunctive Therapy in MDD With Anhedonia

NCT06514742Phase 3

Key facts

Status: Terminated
Start: Jun 2024
Primary completion: Apr 2025
Countries: 9
Sponsor: Janssen Pharmaceutical
Modality: Small Molecules

Drugs: aticaprant
Conditions: major depressive disorder (MDD)anhedonia ((none))

Overview

Phase 3, randomised, double-blind trial of aticaprant in major depressive disorder (MDD) and anhedonia ((none)), sponsored by Janssen Pharmaceutical. Primary endpoint: Montgomery-Asberg Depression Rating Scale at Day 43. Started Jun 2024; status: terminated.

Design

Study design: RandomizedDouble-blind

Who it enrols

Adults with MDD and moderate-to-severe anhedonia who have had an inadequate response to 1-5 prior antidepressant treatments and are currently on a stable dose of an SSRI or SNRI.

Endpoints

Primary

Montgomery-Asberg Depression Rating ScaleDay 43

Secondary

Dimensional Anhedonia Rating ScaleDay 43
Changes in Sexual Function Questionnaire - 14 itemsDay 43
Montgomery-Asberg Depression Rating Scale Over TimeWeek 31
Percentage of Responders on MADRSDay 43
Percentage of Participants With Remission on MADRSDay 43
Patient Health Questionnaire - 9 itemsDay 43
Dimensional Anhedonia Rating Scale Over TimeWeek 31
PHQ-9 Anhedonia-Specific Item (Item 1)Week 31

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