Anhedonia, Depressive Disorder, Major
Conditions
Brief summary
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.
Interventions
DRUGAticaprant
Aticaprant will be administered orally.
OTHERPlacebo
Placebo will be administered orally.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time From Randomization Into Double Blind (DB) Treatment Maintenance Phase to the First Documentation of Relapse | From date of DB randomization (Day 113) up to first documentation of relapse (up to early termination of study [Day 140]) | Relapse is defined as any of the following: MADRS total score \>=22 for 2 consecutive assessments separated by 7 (+/-3) days and/or hospitalization or observation for worsening depression, or any clinically relevant event per clinical judgment suggestive of relapse of depressive illness, such as active suicidal ideation with intent or evidence of suicidal behavior based on the Columbia-Suicide Severity Rating Scale (C-SSRS), suicide attempt, completed suicide, or hospitalization for suicide prevention. Relapse date is defined by the second MADRS assessment. MADRS is a clinician-rated 10-item scale scored from 0 (item not present or normal) to 6 (severe or continuous presence of symptoms), with higher scores indicating more severe symptoms. C-SSRS is clinician-rated and reports severity and frequency of suicide-related ideation and behavior, categorized as no ideation/behavior (0), suicidal ideation (1 -5), or suicidal behavior (6 -10), with higher scores reflecting greater severity. |
Countries
Argentina, Belgium, Brazil, Bulgaria, France, Germany, Greece, Mexico, Poland, Romania, Spain, Turkey (Türkiye), United States
Contacts
STUDY_DIRECTORJanssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Participant flow
Recruitment details
Adult subjects who had major depressive disorder (MDD) with moderate-to-severe anhedonia (ANH+) and an inadequate response to an ongoing antidepressant therapy were treated. Study was conducted in 3 phases: Open label (OL) initial treatment phase (IN), OL treatment stabilization (ST) phase and double blind (DB) treatment maintenance (TM) phase.
Pre-assignment details
Subjects who were stable responders in OL phase were planned to be randomised to receive either aticaprant or placebo. Since no subject was randomised to placebo, results for only the aticaprant arm are presented for the DB (TM) phase.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 47 Participants |
| Age, Continuous | 42.5 years STANDARD_DEVIATION 12.58 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 20 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 43 Participants |
| Region of Enrollment Argentina | 5 Participants |
| Region of Enrollment Brazil | 3 Participants |
| Region of Enrollment Bulgaria | 1 Participants |
| Region of Enrollment Germany | 4 Participants |
| Region of Enrollment Mexico | 7 Participants |
| Region of Enrollment Poland | 10 Participants |
| Region of Enrollment United States | 17 Participants |
| Sex: Female, Male Female | 35 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 47 | 0 / 18 | 0 / 2 |
| other Total, other adverse events | 13 / 47 | 5 / 18 | 0 / 2 |
| serious Total, serious adverse events | 0 / 47 | 0 / 18 | 0 / 2 |
Outcome results
None listed