A Study of Aticaprant Plus an Antidepressant to Prevent Return of Depression Symptoms in Participants With Major Depressive Disorder Who Experience a Loss of Interest and Pleasure

Phase 3TerminatedNCT06635135

Janssen Research & Development, LLC48 enrolled

Overview

The purpose of this study is to assess how well aticaprant works compared to placebo when given in addition to antidepressant therapy (selective serotonin reuptake inhibitor \[SSRI\] or serotonin-norepinephrine reuptake inhibitor \[SNRI\]) in preventing return of depression symptoms in participants with major depressive disorder who experience a loss of interest and pleasure and who achieve a stable response after treatment with adjunctive aticaprant.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Depressive Disorder, Major Anhedonia

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Be medically stable based on physical examination (including a brief neurologic examination), medical history, vital signs (including blood pressure), and 12-lead electrocardiogram (ECG) performed at screening and OL baseline * Be medically stable based on clinical laboratory tests performed at screening * Meet DSM-5 diagnostic criteria for recurrent or single episode MDD, without psychotic features upon clinical assessment and confirmed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders-5th Edition (DSM-5) Axis I Disorders-Clinical Trials version (SCID-CT) * Have symptoms of anhedonia based on clinical assessment and confirmed by presence of anhedonia (positive response to major depressive episode (MDE) module symptom Item 2) on the SCID-CT at screening Exclusion Criteria: * Has had no response to 2 or more consecutive antidepressant treatments administered at adequate dose and duration in the current episode of depression including the current selective SSRI/SNRI assessed using the Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (MGH ATRQ) * Has a history or evidence of clinically meaningful noncompliance with current antidepressant therapy * Has a history of moderate-to-severe substance use disorder including alcohol use disorder according to DSM-5 criteria within 6 months before screening * Has homicidal ideation/intent, per the investigator's clinical judgment, or has suicidal ideation with some intent to act within 3 months prior to the start of the screening phase * Has cognitive impairment per investigator judgment that would render the informed consent invalid or limit the ability of the participant to comply with the study requirements

Locations (95)

Preferred Research Partners

Little Rock, Arkansas, United States

Wake Research PRI Encino

Encino, California, United States

Wr Pri Llc

Newport Beach, California, United States

ATP Clinical Research

Orange, California, United States

Myndful Research

Redlands, California, United States

Artemis Institute for Clinical Research

Outcomes

Primary Outcomes

Time from Randomization into Double Blind (DB) Treatment Maintenance Phase to First Documentation of Relapse

Time from randomization into the DB treatment maintenance phase to the first documentation of a depression relapse event will be reported.

Time frame: From randomization in DB phase to first relapse during the DB maintenance phase (that is [i.e.], up to 2 years 2 months in DB phase)

Secondary Outcomes

Change in Sexual Function (SF) Measured by Changes in Sexual Functioning Questionnaire - Short-Form (CSFQ-14) Total Score From DB Baseline to End of Week 4 of the DB Treatment Maintenance Phase

Change in SF measured by CSFQ-14 total score from DB baseline to end of week 4 of DB treatment maintenance phase will be reported.

Time frame: From Week 16 (DB baseline) to end of week 4 of DB treatment maintenance phase (i.e., up to Week 20 of the study)

Change from DB baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score to End of DB Treatment Maintenance Phase

Change from DB baseline in the MADRS total score to end of DB treatment maintenance phase will be reported.

Time frame: From Week 16 (DB baseline) up to 2 years 2 months in the DB phase

Percentage of Participants With Remission of Depressive Symptoms MADRS Total Score Less Than or Equal to (<=) 10

Percentage of participants with remission of depressive symptoms defined as MADRS total score \<= 10 will be reported.

Time frame: From Week 16 (DB baseline) up to 2 years 2 months in the DB phase

Percentage of Participants With Remission of Depressive Symptoms (PHQ-9 Total Score <=4)

Percentage of participants with remission of depressive symptoms defined by Patient Health Questionnaire, 9-item (PHQ-9) total score \<=4 will be reported.

Time frame: From Week 16 (DB baseline) up to 2 years 2 months in the DB phase

Percentage of Participants With Response of Depressive Symptoms Based on MADRS Total Score Over Time

Percentage of participants with response defined as greater than or equal to (\>=) 50% improvement in the MADRS total score over time will be reported.

Time frame: For open-label (OL) treatment phase: Baseline (Day 1) up to Week 16; For DB Phase: From Week 16 (DB Baseline) up to 2 years 2 months in DB phase

Percentage of Participants With Response of Depressive Symptoms Based on PHQ-9 Total Score Over Time

Percentage of participants with response of depressive symptoms based on PHQ-9 total score over time will be reported.

Time frame: For OL treatment phase: Baseline (Day 1) up to Week 16; For DB Phase: From Week 16 (DB Baseline) up to 2 years 2 months in the DB phase

Change from DB Baseline in the Clinical Global Impression - Severity (CGI-S) Depression Scale Score

Change from DB baseline in the CGI-S depression scale score will be reported.

Time frame: From Week 16 (DB baseline) up to 2 years 2 months in the DB phase

Change from DB Baseline in PHQ-9 Total Score

Change from DB baseline in PHQ-9 total score will be reported.

Time frame: From Week 16 (DB baseline) up to 2 years 2 months in the DB phase

Change From DB Baseline in Anhedonia as Assessed by the Dimensional Anhedonia Rating Scale (DARS) Total Score

Change from DB baseline in Anhedonia as assessed by the DARS total score will be reported.

Time frame: From Week 16 (DB baseline) up to 2 years 2 months in the DB phase

Change from DB Baseline in Snaith-Hamilton Pleasure Scale (SHAPS) Score to End of DB Treatment Phase

Change from DB baseline in SHAPS score to end of DB treatment phase will be reported.

Time frame: From Week 16 (DB baseline) up to 2 years 2 months in the DB phase

Percentage of Participants who Relapse and Have Evidence of Anhedonia Over Time

Percentage of participants who relapse and have evidence of anhedonia over time will be reported.

Time frame: From Week 16 (DB baseline) up to 2 years 2 months in the DB phase

Change from DB Baseline in the Generalized Anxiety Disorder 7-Item Scale (GAD-7) Total Score Over Time

Change from DB baseline in the GAD-7 total score over time will be reported.

Time frame: From Week 16 (DB baseline) up to 2 years 2 months in the DB phase

Change from DB Baseline in SF Measured by CSFQ-14 Total Score and SF Domain Scores Over Time

Change from DB baseline in SF measured by CSFQ-14 total score and SF domain scores over time will be reported.

Time frame: From Week 16 (DB baseline) up to 2 years 2 months in the DB phase