A Phase 3 interventional study of Aticaprant in Depressive Disorder, Major, sponsored by Janssen Research & Development, LLC. Terminated at 234 sites in 21 countries. Open to participants aged 18 Years to 74 Years. Per ClinicalTrials.gov, last updated 2026-10-06.
Sponsored by Janssen Research & Development, LLC · Phase 3, Interventional, and Treatment
The purpose of this study is to assess the long-term safety and tolerability of aticaprant administered as adjunctive therapy to a current antidepressant (selective serotonin reuptake inhibitor [SSRI] or serotonin and norepinephrine reuptake inhibitor [SNRI]) in all participants with major depressive disorder (MDD).
2,741 studies on the registry are indexed under Depressive Disorder, Major; 559 are open to participants now.
This study's enrollment of 871 is above the median of 80 across 2,283 interventional studies indexed under Depressive Disorder, Major.
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Transferred-entry participants:
-Participants must have completed the double blind (DB) (expand DB) Treatment Phase of Study 67953964MDD3001 or Study 67953964MDD3002 without early treatment discontinuation or switch in the oral selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor (SSRI/SNRI) in the parent study
Direct-entry participants:
Direct-entry and Transferred-entry Participants:
-Participants should not take any prohibited medication or food supplements
Exclusion Criteria:
Transferred-entry Participants:
Direct-entry Participants:
Participants will enter this study directly or after completing double-blind phase of studies 67953964MDD3001 or 67953964MDD3002 and will receive Aticaprant 10 milligrams (mg), once daily, orally in addition to the current antidepressant selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor (SSRI/SNRI) therapy on Day 1 up to 52 weeks.
Drug: Aticaprant
Aticaprant 10 mg tablet will be administered orally.
Also known as: JNJ-67953964
Open Label (OL) Treatment Phase: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and AEs of Special Interest (AESI)
An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the intervention. TEAEs were defined as any AE occurring at or after the initial administration of study intervention through the end of OL treatment phase. TEAEs included both serious and non serious AEs. AESI was defined as adverse events that were considered to be of special interest in this study.
Time frame: From start of open-label treatment (Day 1) up to Week 52
Follow-up Phase: Number of Participants With Adverse Events (AEs) and AEs of Special Interest (AESI)
An AE was any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the intervention. AESI was defined as adverse events that were considered to be of special interest in this study.
Time frame: From Week 52 to Week 54
Change From Baseline in Vital Sign Parameter: Blood Pressure (Systolic and Diastolic Blood Pressure)
Change from baseline in vital sign parameter (systolic blood pressure \[SBP\] and diastolic blood pressure \[DBP\]) was reported. Baseline (OL) was defined as the assessment taken on or prior to the first dose of study intervention in this OL study.
Time frame: Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 4 to Week 52), and Follow-up (OL) (up to 14 days after endpoint (OL) [maximum up to Week 54])
Change From Baseline in Vital Sign Parameter: Pulse Rate
Change from baseline in vital sign parameter (pulse rate) was reported. Baseline (OL) was defined as the assessment taken on or prior to the first dose of study intervention in this OL study.
Time frame: Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 4 to Week 52), and Follow-up (OL) (up to 14 days after endpoint (OL) [maximum up to Week 54])
Change From Baseline in Vital Sign Parameter: Temperature
Change from baseline in vital sign parameter (temperature) was reported. Baseline (OL) was defined as the assessment taken on or prior to the first dose of study intervention in this OL study.
Time frame: Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 4 to Week 52), and Follow-up (OL) (up to 14 days after endpoint (OL) [maximum up to Week 54])
Change From Baseline in Vital Sign Parameter: Weight
Change from baseline in vital sign parameter (weight) was reported. Baseline (OL) was defined as the assessment taken on or prior to the first dose of study intervention in this OL study.
Time frame: Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52), and Follow-up (OL) (up to 14 days after endpoint (OL) [maximum up to Week 54])
Change From Baseline in Body Mass Index (BMI)
Change from baseline in BMI was reported. Baseline (OL) was defined as the assessment taken on or prior to the first dose of study intervention in this OL study.
Time frame: Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52), and Follow-up (OL) (up to 14 days after endpoint (OL) [maximum up to Week 54])
OL Treatment Phase: Number of Participants With Shift From Baseline in Suicidal Ideation or Suicidal Behavior as Assessed by Columbia Suicidality Severity Rating Scale (C-SSRS)
C-SSRS was a clinician-rated instrument that reports severity and frequency of suicide-related ideation and behaviors. Suicidal ideation was classified on a 5-item scale: 1 (wish to be dead), 2 (non-specific active suicidal thoughts), 3 (suicidal ideation without plan and intent), 4 (suicidal ideation intent to act without plan), and 5 (suicidal ideation with plan and intent). Suicidal behavior was classified on a 5-item scale: 6 (preparatory acts or behavior), 7 (aborted attempt), 8 (interrupted attempt), 9 (actual attempt \[non-fatal\]), and 10 (suicide). Total score from 10 categories was summarized into 3 categories: No suicidal ideation or behavior(0), suicidal ideation(1-5), suicidal behavior(6-10). Total score ranged from 0 to 10. Higher scores=more severe suicidal ideation and behavior. Baseline=most recent assessment prior to first dose of study treatment in parent study (NCT05455684 and NCT05550532). Categories with at least 1 non-zero data values are reported.
Time frame: Baseline (DB, Day 1) up to Endpoint (OL) (at any time between Week 4 to Week 52) (Up to Week 58 from DB baseline)
Follow-up Phase: Number of Participants With Shift From Baseline in Suicidal Ideation or Suicidal Behavior as Assessed by C-SSRS
C-SSRS was a clinician-rated instrument that reports severity and frequency of suicide-related ideation and behaviors. Suicidal ideation was classified on a 5-item scale: 1 (wish to be dead), 2 (non-specific active suicidal thoughts), 3 (suicidal ideation without plan and intent), 4 (suicidal ideation intent to act without plan), and 5 (suicidal ideation with plan and intent). Suicidal behavior was classified on a 5-item scale: 6 (preparatory acts or behavior), 7 (aborted attempt), 8 (interrupted attempt), 9 (actual attempt \[non-fatal\]), and 10 (suicide). Total score from 10 categories was summarized into 3 categories: No suicidal ideation or behavior(0), suicidal ideation(1-5), suicidal behavior(6-10). Total score ranged from 0 to 10. Higher scores=more severe suicidal ideation and behavior. Baseline=most recent assessment prior to first dose of study treatment in parent study (NCT05455684 and NCT05550532). Categories with at least 1 non-zero data values are reported.
Time frame: Baseline (DB, Day 1), and Follow-up (OL) (up to 14 days after endpoint [OL] [at any time between Week 4 to Week 52]) (maximum up to Week 54 from OL baseline and Week 60 from DB baseline)
OL Treatment Phase: Change From Baseline in Laboratory Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase, Gamma Glutamyl Transferase
Change from baseline in laboratory parameters (alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, creatine kinase, gamma glutamyl transferase) was reported. Baseline (OL) was defined as the assessment taken on or prior to the first dose of study intervention in this OL study.
Time frame: Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52)
OL Treatment Phase: Change From Baseline in Laboratory Parameters: Albumin, Protein, Erythrocyte (Ery.) Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin
Change from baseline in laboratory parameters (albumin, protein, Ery. mean corpuscular HGB concentration, hemoglobin) was reported. Baseline (OL) was defined as the assessment taken on or prior to the first dose of study intervention in this OL study.
Time frame: Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52)
OL Treatment Phase: Change From Baseline in Laboratory Parameters: Bicarbonate, Calcium, Chloride, Cholesterol, Glucose, HDL Cholesterol, LDL Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Triglycerides, Urea Nitrogen
Change from baseline in laboratory parameters (bicarbonate, calcium, chloride, cholesterol, glucose, HDL cholesterol, LDL cholesterol, magnesium, phosphate, potassium, sodium, triglycerides, urea nitrogen) was reported. Baseline (OL) was defined as the assessment taken on or prior to this first dose of study intervention in this OL study.
Time frame: Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52)
OL Treatment Phase: Change From Baseline in Laboratory Parameters: Bilirubin, Creatinine, Direct Bilirubin, Indirect Bilirubin, Urate
Change from baseline in laboratory parameters (bilirubin, creatinine, direct bilirubin, indirect bilirubin, urate) was reported. Baseline (OL) was defined as the assessment taken on or prior to the first dose of study intervention in this OL study.
Time frame: Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52)
OL Treatment Phase: Change From Baseline in Laboratory Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets, Leukocytes
Change from baseline in laboratory parameters (basophils, eosinophils, lymphocytes, monocytes, platelets, leukocytes) was reported. Baseline (OL) was defined as the assessment taken on or prior to the first dose of study intervention in this OL study.
Time frame: Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52)
OL Treatment Phase: Change From Baseline in Laboratory Parameter: Ery. Mean Corpuscular Hemoglobin (MCH)
Change from baseline in laboratory parameter (Ery. MCH) was reported. Baseline (OL) was defined as the assessment taken on or prior to the first dose of study intervention in this OL study.
Time frame: Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52)
OL Treatment Phase: Change From Baseline in Laboratory Parameter: Ery. Mean Corpuscular Volume (MCV)
Change from baseline in laboratory parameter (Ery. MCV) was reported. Baseline (OL) was defined as the assessment taken on or prior to the first dose of study intervention in this OL study.
Time frame: Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52)
OL Treatment Phase: Change From Baseline in Laboratory Parameter: Hematocrit
Change from baseline in laboratory parameter (hematocrit) was reported. Baseline (OL) was defined as the assessment taken on or prior to the first dose of study intervention in this OL study.
Time frame: Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52)
OL Treatment Phase: Change From Baseline in Laboratory Parameter: Specific Gravity
Change from baseline in laboratory parameter (specific gravity) was reported. Baseline (OL) was defined as the assessment taken on or prior to the first dose of study intervention in this OL study.
Time frame: Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52)
OL Treatment Phase: Change From Baseline in Laboratory Parameter: Urine pH
Change from baseline in laboratory parameter (urine pH) was reported. Baseline (OL) was defined as the assessment taken on or prior to the first dose of study intervention in this OL study.
Time frame: Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52)
OL Treatment Phase: Change From Baseline in Laboratory Parameter: Hyaline Casts
Change from baseline in laboratory parameter (hyaline casts) was reported. Baseline (OL) was defined as the assessment taken on or prior to the first dose of study intervention in this OL study.
Time frame: Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52)
OL Treatment Phase: Change From Baseline in Laboratory Parameter: Squamous Epithelial Cells, Transitional Epithelial Cells, Tubular Epithelial Cells, Urine Erythrocytes, Urine Leukocytes
Change from baseline in laboratory parameters (squamous epithelial cells, transitional epithelial cells, tubular epithelial cells, urine erythrocytes, urine leukocytes) was reported. Baseline (OL) was defined as the assessment taken on or prior to the first dose of study intervention in the OL study.
Time frame: Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52)
OL Treatment Phase: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, RR Interval, QTcB Interval, QTcF Interval
Change from baseline in ECG parameters (PR interval, QRS duration, QT interval, RR interval, QTcB interval, QTcF interval) was reported. Baseline (OL) was defined as the assessment taken on or prior to the first dose of study intervention in this OL study.
Time frame: Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52)
OL Treatment Phase: Number of Participants With Withdrawal Symptoms as Assessed by Physician Withdrawal Checklist 20-item (PWC-20)
Number of participants with withdrawal symptoms as assessed by PWC-20 was reported. PWC-20 was a simple and accurate method used to assess potential withdrawal symptoms following cessation of treatment. Items were as follows: loss of appetite, nausea-vomiting, diarrhea, anxiety-nervousness, irritability, dysphoric mood-depression, insomnia, fatigue, poor coordination, restlessness, diaphoresis, tremor, dizziness, headaches, muscle aches or stiffness, weakness, increased acuity sound smell touch, paresthesias, difficulty concentrating-remember, depersonalization-derealization. Each item score ranges from 0 (not present)-3 (severe), where 0=not present, 1=mild, 2=moderate, 3=severe. Higher scores indicated more affected condition.
Time frame: Endpoint (OL) (at any time between Day 2 to Week 52)
Follow-up Phase: Number of Participants With Withdrawal Symptoms as Assessed by Physician Withdrawal Checklist 20-item (PWC-20)
Number of participants with withdrawal symptoms as assessed by PWC-20 was reported. PWC-20 was a simple and accurate method used to assess potential withdrawal symptoms following cessation of treatment. Items were as follows: loss of appetite, nausea-vomiting, diarrhea, anxiety-nervousness, irritability, dysphoric mood-depression, insomnia, fatigue, poor coordination, restlessness, diaphoresis, tremor, dizziness, headaches, muscle aches or stiffness, weakness, increased acuity sound smell touch, paresthesias, difficulty concentrating-remember, depersonalization-derealization. Each item score ranges from 0 (not present)-3 (severe), where 0=not present, 1=mild, 2=moderate, 3=severe. Higher scores indicated more affected condition.
Time frame: Follow-up (up to 14 days after endpoint (OL) [at any time between Day 2 to Week 52 {maximum up to Week 54}])
OL Treatment Phase: Percentage of Participants With Clinically Relevant Sexual Dysfunction Over Time as Determined by Arizona Sexual Experiences Scale (ASEX)
The ASEX was a patient-reported 5-item rating scale, which was used to quantify sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm. Each of the 5 items was rated on a 6-point Likert scale, ranging from 1 to 6. The 5 items are summed to create a total score, ranging from 5 to 30, with the higher scores indicating more sexual dysfunction. Sexual dysfunction was defined as an ASEX total score of 19 or greater, or a score of 5 or greater on any item, or a score of 4 or greater on any 3 items.
Time frame: Endpoint (OL) (at any time between Week 12 to Week 52)
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
The MADRS was a clinician-rated scale designed to measure depression severity and detect changes due to antidepressant treatment. The scale consists of 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of symptoms). MADRS total score is the sum of scores from individual question items, which ranges from 0 to 60; higher scores represent a more severe condition. Negative change in MADRS total score indicated improvement. Baseline (OL) was defined as the assessment taken on or prior to the first dose of study intervention in this OL study.
Time frame: Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 4 to Week 52), and Follow-up (OL) (up to 14 days after endpoint [OL] [at any time between Week 4 to Week 52 {maximum up to Week 54}])
Change From Baseline in Patient Health Questionnaire, 9-item (PHQ-9) Total Score
Change from baseline in PHQ-9 total score was reported. The PHQ-9 was a 9-item, participant reported outcome measure to assess depressive symptoms. The scale scores each of the 9 symptom domains of the Diagnostic and Statistical Manual of Mental Disorders-5th Edition (DSM-5) MDD criteria. Each item was rated on a 4 point scale (0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day). The participant's item responses are summed to provide a total score (range of 0 to 27), with higher scores indicating greater severity of depressive symptoms. The severity of the PHQ-9 was categorized as follows: none-minimal (0-4), mild (5-9), moderate (10-14), moderately severe (15-19) and severe (20-27). Negative changes in PHQ-9 total score indicated improvement. Baseline (OL) was defined as the assessment taken on or prior to the first dose of study intervention in this OL study.
Time frame: Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52), and Follow-up (OL) (up to 14 days after endpoint [OL] [at any time between Week 12 to Week 52 {maximum up to Week 54}])
Change From Baseline in Dimensional Anhedonia Rating Scale (DARS) Total Score
Change from baseline in DARS total score was reported. The DARS was a 17-item self-report questionnaire that is designed to assess anhedonia in MDD across the 4 domains: hobbies, social activities, food/drink, and sensory experience. The DARS scale measures desire, motivation, effort, and consummatory pleasure. The DARS was rated on a 5-point Likert scale (0=not at all, 1=slightly, 2=moderately, 3=mostly, 4=very much) and responses were summed to generate the total score (ranges from 0 to 68). A lower total score was indicative of greater anhedonia. Positive changes in DARS total score indicated improvement. Baseline (OL) was defined as the assessment taken on or prior to the first dose of study intervention in this OL study.
Time frame: Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 4 to Week 52), and Follow-up (OL) (up to 14 days after endpoint [OL] [at any time between Week 4 to Week 52 {maximum up to Week 54}])
Change From Baseline in Clinical Global Impression-Severity (CGI-S) Total Score
CGI-S provides an overall clinician-determined summary measure of severity of participant's illness that takes into account all available information, including knowledge of participant's history, psychosocial circumstances, symptoms, behavior, and impact of symptoms on participant's ability to function. CGI-S 7-point scale was a global assessment that measures the clinician's impression of severity of illness of the participant. CGI-S evaluates the severity of psychopathology on a scale of 0 to 7. Considering total clinical experience, a participant was assessed on severity of mental illness at time of rating according to: 0=not assessed; 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among most extremely ill participants. Higher score=more severe illness. Negative changes in CGI-S score indicated improvement. Baseline (OL)=assessment taken on or prior to first dose of study intervention in this OL study.
Time frame: Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 4 to Week 52), and Follow-up (OL) (up to 14 days after endpoint [OL] [at any time between Week 4 to Week 52 {maximum up to Week 54}])
Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%) Reduction From Baseline in the MADRS Total Score
Percentage of participants with \>=50% reduction from baseline in MADRS total score was reported. A participant was defined as responder at a given time point if percent improvement from baseline in MADRS total score was \>=50% at that time point. MADRS was a clinician-rated scale designed to measure depression severity and detect changes due to antidepressant treatment. Scale consisted of 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts), each of which scored from 0 (item not present or normal) to 6 (severe or continuous presence of symptoms). MADRS total score was sum of scores from individual question items, which ranged from 0 to 60; higher scores=more severe condition. Negative change in MADRS total score = improvement. Baseline=most recent assessment prior to first dose of study treatment in parent study (NCT05455684 and NCT05550532).
Time frame: At Endpoint (OL) (at any time between Week 4 to Week 52), and Follow-up (OL) (up to 14 days after endpoint [OL] [at any time between Week 4 to Week 52 {maximum up to Week 54}])
Percentage of Participants With Remission of Depressive Symptoms
Percentage of participants with remission of depressive symptoms was reported. A participant was defined as remitter at a given time point if the MADRS total score less than or equal to (\<=) 10 at that time point. MADRS was a clinician-rated scale designed to measure depression severity and detect changes due to antidepressant treatment. Scale consists of 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of symptoms). MADRS total score was the sum of scores from individual question items, which ranges from 0 to 60; higher scores represent a more severe condition. Negative change in MADRS total score indicated improvement.
Time frame: At Endpoint (OL) (at any time between Week 4 to Week 52), and Follow-up (up to 14 days after endpoint [OL] [at any time between Week 4 to Week 52 {maximum up to Week 54}])
| Milestone | Aticaprant 10 mg |
|---|---|
| Started | 871 |
| Participants who entered in follow-up phase | 748 |
| Completed | 249 |
| Not completed | 622 |
| Withdrew: Adverse event | 42 |
| Withdrew: Death | 1 |
| Withdrew: Lost to follow-up | 20 |
| Withdrew: Pregnancy | 1 |
| Withdrew: Protocol violation | 1 |
| Withdrew: Withdrawal by subject | 56 |
| Withdrew: Study terminated by sponsor | 404 |
| Withdrew: Other | 90 |
| Withdrew: Non-compliance with study drug | 4 |
| Withdrew: Positive urine drug screen for phencyclidine (pcp) or cocaine | 2 |
| Withdrew: Enrolled but not treated | 1 |
An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the intervention. TEAEs were defined as any AE occurring at or after the initial administration of study intervention through the end of OL treatment phase. TEAEs included both serious and non serious AEs. AESI was defined as adverse events that were considered to be of special interest in this study.
| Participants | Aticaprant 10 mg |
|---|---|
| TEAEs | 504 |
| AESI | 71 |
An AE was any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the intervention. AESI was defined as adverse events that were considered to be of special interest in this study.
| Participants | Aticaprant 10 mg |
|---|---|
| AEs | 36 |
| AESI | 0 |
Change from baseline in vital sign parameter (systolic blood pressure \[SBP\] and diastolic blood pressure \[DBP\]) was reported. Baseline (OL) was defined as the assessment taken on or prior to the first dose of study intervention in this OL study.
| Millimeters of mercury (mmHg) | Aticaprant 10 mg |
|---|---|
| SBP: Endpoint (OL) | 0.5 ± 10.99 |
| SBP: Follow-up (OL) | 0.3 ± 11.60 |
| DBP: Endpoint (OL) | 0.7 ± 8.52 |
| DBP: Follow-up (OL) | 1.2 ± 8.53 |
Change from baseline in vital sign parameter (pulse rate) was reported. Baseline (OL) was defined as the assessment taken on or prior to the first dose of study intervention in this OL study.
| Beats per minute | Aticaprant 10 mg |
|---|---|
| Endpoint (OL) | 2.1 ± 10.01 |
| Follow-up (OL) | 3.4 ± 9.95 |
Change from baseline in vital sign parameter (temperature) was reported. Baseline (OL) was defined as the assessment taken on or prior to the first dose of study intervention in this OL study.
| Degree Celsius (C) | Aticaprant 10 mg |
|---|---|
| Endpoint (OL) | 0.00 ± 0.347 |
| Follow-up (OL) | -0.01 ± 0.379 |
Change from baseline in vital sign parameter (weight) was reported. Baseline (OL) was defined as the assessment taken on or prior to the first dose of study intervention in this OL study.
| Kilograms (Kg) | Aticaprant 10 mg |
|---|---|
| Endpoint (OL) | 0.32 ± 4.074 |
| Follow-up (OL) | 0.49 ± 4.296 |
Change from baseline in BMI was reported. Baseline (OL) was defined as the assessment taken on or prior to the first dose of study intervention in this OL study.
| Kilograms per meter square (kg/m^2) | Aticaprant 10 mg |
|---|---|
| Endpoint (OL) | 0.12 ± 1.456 |
| Follow-up (OL) | 0.18 ± 1.532 |
C-SSRS was a clinician-rated instrument that reports severity and frequency of suicide-related ideation and behaviors. Suicidal ideation was classified on a 5-item scale: 1 (wish to be dead), 2 (non-specific active suicidal thoughts), 3 (suicidal ideation without plan and intent), 4 (suicidal ideation intent to act without plan), and 5 (suicidal ideation with plan and intent). Suicidal behavior was classified on a 5-item scale: 6 (preparatory acts or behavior), 7 (aborted attempt), 8 (interrupted attempt), 9 (actual attempt \[non-fatal\]), and 10 (suicide). Total score from 10 categories was summarized into 3 categories: No suicidal ideation or behavior(0), suicidal ideation(1-5), suicidal behavior(6-10). Total score ranged from 0 to 10. Higher scores=more severe suicidal ideation and behavior. Baseline=most recent assessment prior to first dose of study treatment in parent study (NCT05455684 and NCT05550532). Categories with at least 1 non-zero data values are reported.
| Participants | Aticaprant 10 mg |
|---|---|
| Baseline no suicidal ideation or behavior (SI/SB) to post-baseline no SI/SB | 639 |
| Baseline no SI/SB to post-baseline suicidal ideation | 79 |
| Baseline no SI/SB to post-baseline suicidal behavior | 1 |
| Baseline suicidal ideation to post-baseline no SI/SB | 45 |
| Baseline suicidal ideation to post-baseline suicidal ideation | 96 |
| Baseline suicidal ideation to post-baseline suicidal behavior | 3 |
C-SSRS was a clinician-rated instrument that reports severity and frequency of suicide-related ideation and behaviors. Suicidal ideation was classified on a 5-item scale: 1 (wish to be dead), 2 (non-specific active suicidal thoughts), 3 (suicidal ideation without plan and intent), 4 (suicidal ideation intent to act without plan), and 5 (suicidal ideation with plan and intent). Suicidal behavior was classified on a 5-item scale: 6 (preparatory acts or behavior), 7 (aborted attempt), 8 (interrupted attempt), 9 (actual attempt \[non-fatal\]), and 10 (suicide). Total score from 10 categories was summarized into 3 categories: No suicidal ideation or behavior(0), suicidal ideation(1-5), suicidal behavior(6-10). Total score ranged from 0 to 10. Higher scores=more severe suicidal ideation and behavior. Baseline=most recent assessment prior to first dose of study treatment in parent study (NCT05455684 and NCT05550532). Categories with at least 1 non-zero data values are reported.
| Participants | Aticaprant 10 mg |
|---|---|
| Baseline no SI/SB to post-baseline no SI/SB | 620 |
| Baseline no SI/SB to post-baseline suicidal ideation | 11 |
| Baseline suicidal ideation to post-baseline no SI/SB | 81 |
| Baseline suicidal ideation to post-baseline suicidal ideation | 32 |
| Baseline suicidal ideation to post-baseline suicidal behavior | 1 |
Change from baseline in laboratory parameters (alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, creatine kinase, gamma glutamyl transferase) was reported. Baseline (OL) was defined as the assessment taken on or prior to the first dose of study intervention in this OL study.
| Enzyme unit per liter | Aticaprant 10 mg |
|---|---|
| Alanine Aminotransferase | -0.3 ± 13.97 |
| Alkaline Phosphatase | 2.0 ± 21.22 |
| Aspartate Aminotransferase | 0.2 ± 9.69 |
| Creatine Kinase | 2.9 ± 175.35 |
| Gamma Glutamyl Transferase | 0.9 ± 32.13 |
Change from baseline in laboratory parameters (albumin, protein, Ery. mean corpuscular HGB concentration, hemoglobin) was reported. Baseline (OL) was defined as the assessment taken on or prior to the first dose of study intervention in this OL study.
| Grams per liter (g/L) | Aticaprant 10 mg |
|---|---|
| Albumin | -0.1 ± 2.41 |
| Protein | -0.1 ± 4.09 |
| Ery. Mean Corpuscular HGB Concentration | 10.0 ± NA |
| Hemoglobin | 1.6 ± 8.59 |
Change from baseline in laboratory parameters (bicarbonate, calcium, chloride, cholesterol, glucose, HDL cholesterol, LDL cholesterol, magnesium, phosphate, potassium, sodium, triglycerides, urea nitrogen) was reported. Baseline (OL) was defined as the assessment taken on or prior to this first dose of study intervention in this OL study.
| Millimoles per liter (mmol/L) | Aticaprant 10 mg |
|---|---|
| Bicarbonate | -0.12 ± 2.473 |
| Calcium | 0.0146 ± 0.10668 |
| Chloride | 0.0 ± 2.65 |
| Cholesterol | -0.1719 ± 0.73310 |
| Glucose | 0.0569 ± 1.21955 |
| HDL Cholesterol | 0.0012 ± 0.20212 |
| LDL Cholesterol | -0.0870 ± 0.59898 |
| Magnesium | -0.0282 ± 0.06957 |
| Phosphate | -0.0117 ± 0.17992 |
| Potassium | 0.00 ± 0.430 |
| Sodium | -0.1 ± 2.41 |
| Triglyceride | -0.1404 ± 0.57968 |
| Urea Nitrogen | 0.1063 ± 1.31795 |
Change from baseline in laboratory parameters (bilirubin, creatinine, direct bilirubin, indirect bilirubin, urate) was reported. Baseline (OL) was defined as the assessment taken on or prior to the first dose of study intervention in this OL study.
| Micromoles per liter (mcmol/L) | Aticaprant 10 mg |
|---|---|
| Bilirubin | -0.064 ± 3.2284 |
| Creatinine | 0.5291 ± 8.66028 |
| Direct Bilirubin | 0.1834 ± 0.80098 |
| Indirect Bilirubin | -1.000 ± NA |
| Urate | -1.1815 ± 50.7414 |
Change from baseline in laboratory parameters (basophils, eosinophils, lymphocytes, monocytes, platelets, leukocytes) was reported. Baseline (OL) was defined as the assessment taken on or prior to the first dose of study intervention in this OL study.
| 10^9 cells/Liter | Aticaprant 10 mg |
|---|---|
| Basophils | -0.003 ± 0.0360 |
| Eosinophils | 0.003 ± 0.1073 |
| Lymphocytes | 0.003 ± 0.4690 |
| Monocytes | 0.006 ± 0.1344 |
| Platelets | 2.7 ± 43.22 |
| Leukocytes | 0.049 ± 1.7214 |
Change from baseline in laboratory parameter (Ery. MCH) was reported. Baseline (OL) was defined as the assessment taken on or prior to the first dose of study intervention in this OL study.
| Picograms (pg) | Aticaprant 10 mg |
|---|---|
| OL Treatment Phase: Change From Baseline in Laboratory Parameter: Ery. Mean Corpuscular Hemoglobin (MCH) | 0.1 ± 1.23 |
Change from baseline in laboratory parameter (Ery. MCV) was reported. Baseline (OL) was defined as the assessment taken on or prior to the first dose of study intervention in this OL study.
| Femtoliters (fL) | Aticaprant 10 mg |
|---|---|
| OL Treatment Phase: Change From Baseline in Laboratory Parameter: Ery. Mean Corpuscular Volume (MCV) | -0.6 ± 3.85 |
Change from baseline in laboratory parameter (hematocrit) was reported. Baseline (OL) was defined as the assessment taken on or prior to the first dose of study intervention in this OL study.
| Percentage of blood cells | Aticaprant 10 mg |
|---|---|
| OL Treatment Phase: Change From Baseline in Laboratory Parameter: Hematocrit | 0.001 ± 0.0283 |
Change from baseline in laboratory parameter (specific gravity) was reported. Baseline (OL) was defined as the assessment taken on or prior to the first dose of study intervention in this OL study.
| Ratio | Aticaprant 10 mg |
|---|---|
| OL Treatment Phase: Change From Baseline in Laboratory Parameter: Specific Gravity | -0.0002 ± 0.00842 |
Change from baseline in laboratory parameter (urine pH) was reported. Baseline (OL) was defined as the assessment taken on or prior to the first dose of study intervention in this OL study.
| Potential of Hydrogen (pH) | Aticaprant 10 mg |
|---|---|
| OL Treatment Phase: Change From Baseline in Laboratory Parameter: Urine pH | 0.05 ± 0.581 |
Change from baseline in laboratory parameter (hyaline casts) was reported. Baseline (OL) was defined as the assessment taken on or prior to the first dose of study intervention in this OL study.
| Per low power field (/LPF) | Aticaprant 10 mg |
|---|---|
| OL Treatment Phase: Change From Baseline in Laboratory Parameter: Hyaline Casts | -1.0 ± 6.36 |
Change from baseline in laboratory parameters (squamous epithelial cells, transitional epithelial cells, tubular epithelial cells, urine erythrocytes, urine leukocytes) was reported. Baseline (OL) was defined as the assessment taken on or prior to the first dose of study intervention in the OL study.
| Per high power field (/HPF) | Aticaprant 10 mg |
|---|---|
| Squamous epithelial cells | -6.9 ± 14.74 |
| Transitional epithelial cells | -0.5 ± 0.71 |
| Tubular epithelial cells | 0.8 ± 0.84 |
| Urine erythrocytes | -0.4 ± 32.99 |
| Urine leukocytes | -0.9 ± 22.02 |
Change from baseline in ECG parameters (PR interval, QRS duration, QT interval, RR interval, QTcB interval, QTcF interval) was reported. Baseline (OL) was defined as the assessment taken on or prior to the first dose of study intervention in this OL study.
| Milliseconds (msec) | Aticaprant 10 mg |
|---|---|
| PR interval | -1.4 ± 13.29 |
| QRS duration | -0.7 ± 7.22 |
| QT interval | -5.2 ± 22.71 |
| RR interval | -27.1 ± 117.17 |
| QTcB interval | 0.7 ± 19.23 |
| QTcF interval | -1.3 ± 16.39 |
Number of participants with withdrawal symptoms as assessed by PWC-20 was reported. PWC-20 was a simple and accurate method used to assess potential withdrawal symptoms following cessation of treatment. Items were as follows: loss of appetite, nausea-vomiting, diarrhea, anxiety-nervousness, irritability, dysphoric mood-depression, insomnia, fatigue, poor coordination, restlessness, diaphoresis, tremor, dizziness, headaches, muscle aches or stiffness, weakness, increased acuity sound smell touch, paresthesias, difficulty concentrating-remember, depersonalization-derealization. Each item score ranges from 0 (not present)-3 (severe), where 0=not present, 1=mild, 2=moderate, 3=severe. Higher scores indicated more affected condition.
| Participants | Aticaprant 10 mg |
|---|---|
| Loss of appetite — Not Present | 304 |
| Loss of appetite — Mild | 54 |
| Loss of appetite — Moderate | 25 |
| Loss of appetite — Severe | 7 |
| Nausea-vomiting — Not Present | 362 |
| Nausea-vomiting — Mild | 21 |
| Nausea-vomiting — Moderate | 7 |
| Nausea-vomiting — Severe | 0 |
| Diarrhea — Not Present | 362 |
| Diarrhea — Mild | 19 |
| Diarrhea — Moderate | 7 |
| Diarrhea — Severe | 2 |
| Anxiety-nervousness — Not Present | 218 |
| Anxiety-nervousness — Mild | 93 |
| Anxiety-nervousness — Moderate | 60 |
| Anxiety-nervousness — Severe | 19 |
| Irritability — Not Present | 276 |
| Irritability — Mild | 67 |
| Irritability — Moderate | 36 |
| Irritability — Severe | 11 |
| Dysphoric mood-depression — Not Present | 199 |
| Dysphoric mood-depression — Mild | 109 |
| Dysphoric mood-depression — Moderate | 58 |
| Dysphoric mood-depression — Severe | 24 |
| Insomnia — Not Present | 239 |
| Insomnia — Mild | 83 |
| Insomnia — Moderate | 45 |
| Insomnia — Severe | 23 |
| Fatigue-lethargy-lack of energy — Not Present | 216 |
| Fatigue-lethargy-lack of energy — Mild | 81 |
| Fatigue-lethargy-lack of energy — Moderate | 59 |
| Fatigue-lethargy-lack of energy — Severe | 34 |
| Poor coordination — Not Present | 353 |
| Poor coordination — Mild | 23 |
| Poor coordination — Moderate | 10 |
| Poor coordination — Severe | 4 |
| Restlessness-agitation — Not Present | 308 |
| Restlessness-agitation — Mild | 57 |
| Restlessness-agitation — Moderate | 23 |
| Restlessness-agitation — Severe | 2 |
| Diaphoresis — Not Present | 349 |
| Diaphoresis — Mild | 26 |
| Diaphoresis — Moderate | 13 |
| Diaphoresis — Severe | 2 |
| Tremor-tremulousness — Not Present | 364 |
| Tremor-tremulousness — Mild | 20 |
| Tremor-tremulousness — Moderate | 6 |
| Tremor-tremulousness — Severe | 0 |
| Dizziness — Not Present | 332 |
| Dizziness — Mild | 51 |
| Dizziness — Moderate | 6 |
| Dizziness — Severe | 1 |
| Headaches — Not Present | 307 |
| Headaches — Mild | 61 |
| Headaches — Moderate | 22 |
| Headaches — Severe | 0 |
| Muscle aches or stiffness — Not Present | 327 |
| Muscle aches or stiffness — Mild | 41 |
| Muscle aches or stiffness — Moderate | 18 |
| Muscle aches or stiffness — Severe | 4 |
| Weakness — Not Present | 317 |
| Weakness — Mild | 46 |
| Weakness — Moderate | 21 |
| Weakness — Severe | 6 |
| Increased acuity sound smell touch — Not Present | 356 |
| Increased acuity sound smell touch — Mild | 25 |
| Increased acuity sound smell touch — Moderate | 5 |
| Increased acuity sound smell touch — Severe | 4 |
| Paresthesias — Not Present | 367 |
| Paresthesias — Mild | 18 |
| Paresthesias — Moderate | 4 |
| Paresthesias — Severe | 1 |
| Difficulty concentrating, remember — Not Present | 250 |
| Difficulty concentrating, remember — Mild | 70 |
| Difficulty concentrating, remember — Moderate | 49 |
| Difficulty concentrating, remember — Severe | 21 |
| Depersonalization-derealization — Not Present | 369 |
| Depersonalization-derealization — Mild | 14 |
| Depersonalization-derealization — Moderate | 6 |
| Depersonalization-derealization — Severe | 1 |
Number of participants with withdrawal symptoms as assessed by PWC-20 was reported. PWC-20 was a simple and accurate method used to assess potential withdrawal symptoms following cessation of treatment. Items were as follows: loss of appetite, nausea-vomiting, diarrhea, anxiety-nervousness, irritability, dysphoric mood-depression, insomnia, fatigue, poor coordination, restlessness, diaphoresis, tremor, dizziness, headaches, muscle aches or stiffness, weakness, increased acuity sound smell touch, paresthesias, difficulty concentrating-remember, depersonalization-derealization. Each item score ranges from 0 (not present)-3 (severe), where 0=not present, 1=mild, 2=moderate, 3=severe. Higher scores indicated more affected condition.
| Participants | Aticaprant 10 mg |
|---|---|
| Loss of appetite — Not Present | 284 |
| Loss of appetite — Mild | 42 |
| Loss of appetite — Moderate | 24 |
| Loss of appetite — Severe | 4 |
| Nausea-vomiting — Not Present | 329 |
| Nausea-vomiting — Mild | 17 |
| Nausea-vomiting — Moderate | 5 |
| Nausea-vomiting — Severe | 3 |
| Diarrhea — Not Present | 330 |
| Diarrhea — Mild | 22 |
| Diarrhea — Moderate | 1 |
| Diarrhea — Severe | 1 |
| Anxiety-nervousness — Not Present | 192 |
| Anxiety-nervousness — Mild | 89 |
| Anxiety-nervousness — Moderate | 60 |
| Anxiety-nervousness — Severe | 13 |
| Irritability — Not Present | 257 |
| Irritability — Mild | 56 |
| Irritability — Moderate | 33 |
| Irritability — Severe | 8 |
| Dysphoric mood-depression — Not Present | 186 |
| Dysphoric mood-depression — Mild | 74 |
| Dysphoric mood-depression — Moderate | 77 |
| Dysphoric mood-depression — Severe | 17 |
| Insomnia — Not Present | 216 |
| Insomnia — Mild | 79 |
| Insomnia — Moderate | 37 |
| Insomnia — Severe | 22 |
| Fatigue-lethargy-lack of energy — Not Present | 184 |
| Fatigue-lethargy-lack of energy — Mild | 84 |
| Fatigue-lethargy-lack of energy — Moderate | 58 |
| Fatigue-lethargy-lack of energy — Severe | 28 |
| Poor coordination — Not Present | 322 |
| Poor coordination — Mild | 24 |
| Poor coordination — Moderate | 6 |
| Poor coordination — Severe | 2 |
| Restlessness-agitation — Not Present | 287 |
| Restlessness-agitation — Mild | 46 |
| Restlessness-agitation — Moderate | 15 |
| Restlessness-agitation — Severe | 6 |
| Diaphoresis — Not Present | 317 |
| Diaphoresis — Mild | 27 |
| Diaphoresis — Moderate | 6 |
| Diaphoresis — Severe | 4 |
| Tremor-tremulousness — Not Present | 327 |
| Tremor-tremulousness — Mild | 23 |
| Tremor-tremulousness — Moderate | 4 |
| Tremor-tremulousness — Severe | 0 |
| Dizziness — Not Present | 309 |
| Dizziness — Mild | 34 |
| Dizziness — Moderate | 8 |
| Dizziness — Severe | 3 |
| Headaches — Not Present | 278 |
| Headaches — Mild | 53 |
| Headaches — Moderate | 22 |
| Headaches — Severe | 1 |
| Muscle aches or stiffness — Not Present | 289 |
| Muscle aches or stiffness — Mild | 41 |
| Muscle aches or stiffness — Moderate | 21 |
| Muscle aches or stiffness — Severe | 3 |
| Weakness — Not Present | 293 |
| Weakness — Mild | 35 |
| Weakness — Moderate | 23 |
| Weakness — Severe | 3 |
| Increased acuity sound smell touch — Not Present | 318 |
| Increased acuity sound smell touch — Mild | 29 |
| Increased acuity sound smell touch — Moderate | 5 |
| Increased acuity sound smell touch — Severe | 2 |
| Paresthesias — Not Present | 337 |
| Paresthesias — Mild | 10 |
| Paresthesias — Moderate | 5 |
| Paresthesias — Severe | 2 |
| Difficulty concentrating, remember — Not Present | 230 |
| Difficulty concentrating, remember — Mild | 75 |
| Difficulty concentrating, remember — Moderate | 35 |
| Difficulty concentrating, remember — Severe | 14 |
| Depersonalization-derealization — Not Present | 341 |
| Depersonalization-derealization — Mild | 10 |
| Depersonalization-derealization — Moderate | 2 |
| Depersonalization-derealization — Severe | 1 |
The ASEX was a patient-reported 5-item rating scale, which was used to quantify sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm. Each of the 5 items was rated on a 6-point Likert scale, ranging from 1 to 6. The 5 items are summed to create a total score, ranging from 5 to 30, with the higher scores indicating more sexual dysfunction. Sexual dysfunction was defined as an ASEX total score of 19 or greater, or a score of 5 or greater on any item, or a score of 4 or greater on any 3 items.
| Percentage of Participants | Aticaprant 10 mg |
|---|---|
| OL Treatment Phase: Percentage of Participants With Clinically Relevant Sexual Dysfunction Over Time as Determined by Arizona Sexual Experiences Scale (ASEX) | 72.1 |
The MADRS was a clinician-rated scale designed to measure depression severity and detect changes due to antidepressant treatment. The scale consists of 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of symptoms). MADRS total score is the sum of scores from individual question items, which ranges from 0 to 60; higher scores represent a more severe condition. Negative change in MADRS total score indicated improvement. Baseline (OL) was defined as the assessment taken on or prior to the first dose of study intervention in this OL study.
| Units on a scale | Aticaprant 10 mg |
|---|---|
| Endpoint (OL) | -7.1 ± 12.40 |
| Follow-up | -7.4 ± 12.97 |
Change from baseline in PHQ-9 total score was reported. The PHQ-9 was a 9-item, participant reported outcome measure to assess depressive symptoms. The scale scores each of the 9 symptom domains of the Diagnostic and Statistical Manual of Mental Disorders-5th Edition (DSM-5) MDD criteria. Each item was rated on a 4 point scale (0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day). The participant's item responses are summed to provide a total score (range of 0 to 27), with higher scores indicating greater severity of depressive symptoms. The severity of the PHQ-9 was categorized as follows: none-minimal (0-4), mild (5-9), moderate (10-14), moderately severe (15-19) and severe (20-27). Negative changes in PHQ-9 total score indicated improvement. Baseline (OL) was defined as the assessment taken on or prior to the first dose of study intervention in this OL study.
| Units on a scale | Aticaprant 10 mg |
|---|---|
| Endpoint (OL) | -3.2 ± 7.15 |
| Follow-up | -3.4 ± 7.45 |
Change from baseline in DARS total score was reported. The DARS was a 17-item self-report questionnaire that is designed to assess anhedonia in MDD across the 4 domains: hobbies, social activities, food/drink, and sensory experience. The DARS scale measures desire, motivation, effort, and consummatory pleasure. The DARS was rated on a 5-point Likert scale (0=not at all, 1=slightly, 2=moderately, 3=mostly, 4=very much) and responses were summed to generate the total score (ranges from 0 to 68). A lower total score was indicative of greater anhedonia. Positive changes in DARS total score indicated improvement. Baseline (OL) was defined as the assessment taken on or prior to the first dose of study intervention in this OL study.
| Units on a scale | Aticaprant 10 mg |
|---|---|
| Endpoint (OL) | 9.1 ± 18.35 |
| Follow-up | 8.5 ± 19.38 |
CGI-S provides an overall clinician-determined summary measure of severity of participant's illness that takes into account all available information, including knowledge of participant's history, psychosocial circumstances, symptoms, behavior, and impact of symptoms on participant's ability to function. CGI-S 7-point scale was a global assessment that measures the clinician's impression of severity of illness of the participant. CGI-S evaluates the severity of psychopathology on a scale of 0 to 7. Considering total clinical experience, a participant was assessed on severity of mental illness at time of rating according to: 0=not assessed; 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among most extremely ill participants. Higher score=more severe illness. Negative changes in CGI-S score indicated improvement. Baseline (OL)=assessment taken on or prior to first dose of study intervention in this OL study.
| Units on a scale | Aticaprant 10 mg |
|---|---|
| Endpoint (OL) | -0.9 ± 1.48 |
| Follow-up | -0.9 ± 1.54 |
Percentage of participants with \>=50% reduction from baseline in MADRS total score was reported. A participant was defined as responder at a given time point if percent improvement from baseline in MADRS total score was \>=50% at that time point. MADRS was a clinician-rated scale designed to measure depression severity and detect changes due to antidepressant treatment. Scale consisted of 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts), each of which scored from 0 (item not present or normal) to 6 (severe or continuous presence of symptoms). MADRS total score was sum of scores from individual question items, which ranged from 0 to 60; higher scores=more severe condition. Negative change in MADRS total score = improvement. Baseline=most recent assessment prior to first dose of study treatment in parent study (NCT05455684 and NCT05550532).
| Percentage of participants | Aticaprant 10 mg |
|---|---|
| Endpoint (OL) | 55.2 |
| Follow-up | 57.0 |
Percentage of participants with remission of depressive symptoms was reported. A participant was defined as remitter at a given time point if the MADRS total score less than or equal to (\<=) 10 at that time point. MADRS was a clinician-rated scale designed to measure depression severity and detect changes due to antidepressant treatment. Scale consists of 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of symptoms). MADRS total score was the sum of scores from individual question items, which ranges from 0 to 60; higher scores represent a more severe condition. Negative change in MADRS total score indicated improvement.
| Percentage of participants | Aticaprant 10 mg |
|---|---|
| Endpoint (OL) | 43.8 |
| Follow-up | 44.6 |
Collected over Open-label Treatment Phase: From Day 1 up to Week 52; Follow-up Phase: From Week 52 to Week 54. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Open-label Treatment Phase: Aticaprant 10 mg | 1/870 (0.1%) | 29/870 (3.3%) | 163/870 (18.7%) |
| Follow-up Phase: Aticaprant 10 mg | 0/748 (0%) | 1/748 (0.1%) | 3/748 (0.4%) |
| Event | Open-label Treatment Phase: Aticaprant 10 mg | Follow-up Phase: Aticaprant 10 mg |
|---|---|---|
| DepressionPsychiatric disorders | 3/870 | 0/748 |
| Umbilical HerniaGastrointestinal disorders | 2/870 | 0/748 |
| PneumoniaInfections and infestations | 2/870 | 0/748 |
| Intentional OverdoseInjury, poisoning and procedural complications | 2/870 | 0/748 |
| OsteoarthritisMusculoskeletal and connective tissue disorders | 2/870 | 0/748 |
| Suicidal IdeationPsychiatric disorders | 2/870 | 0/748 |
| Pancreatitis AcuteGastrointestinal disorders | 0/870 | 1/748 |
| Mobile Caecum SyndromeCongenital, familial and genetic disorders | 1/870 | 0/748 |
| Bile Duct StoneHepatobiliary disorders | 1/870 | 0/748 |
| Cholecystitis AcuteHepatobiliary disorders | 1/870 | 0/748 |
| Event | Open-label Treatment Phase: Aticaprant 10 mg | Follow-up Phase: Aticaprant 10 mg |
|---|---|---|
| PruritusSkin and subcutaneous tissue disorders | 72/870 | 0/748 |
| HeadacheNervous system disorders | 61/870 | 1/748 |
| NasopharyngitisInfections and infestations | 52/870 | 2/748 |
Safety analysis set included all participants (adults and elderly) who took at least 1 dose of study treatment.
| Age, Categorical(Participants) | Aticaprant 10 mg |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 753 |
| >=65 years | 117 |
| Age, Continuous(Years) | Aticaprant 10 mg |
|---|---|
| Mean | 49.3 ± 13.7 |
| Sex/Gender, Customized(Participants) | Aticaprant 10 mg |
|---|---|
| Female | 632 |
| Male | 237 |
| Undifferentiated | 1 |
| Ethnicity (NIH/OMB)(Participants) | Aticaprant 10 mg |
|---|---|
| Hispanic or Latino | 251 |
| Not Hispanic or Latino | 596 |
| Unknown or Not Reported | 23 |
| Race (NIH/OMB)(Participants) | Aticaprant 10 mg |
|---|---|
| American Indian or Alaska Native | 2 |
| Asian | 74 |
| Native Hawaiian or Other Pacific Islander | 10 |
| Black or African American | 57 |
| White | 690 |
| More than one race | 6 |
| Unknown or Not Reported | 31 |
| Region of Enrollment(Participants) | Aticaprant 10 mg |
|---|---|
| ARGENTINA | 99 |
| AUSTRALIA | 11 |
| BELGIUM | 22 |
| BRAZIL | 46 |
| BULGARIA | 41 |
| CHINA | 43 |
| CZECH REPUBLIC | 55 |
| FRANCE | 18 |
| HUNGARY | 6 |
| ITALY | 2 |
| POLAND | 56 |
| PORTUGAL | 5 |
| SLOVAKIA | 32 |
| SOUTH AFRICA | 25 |
| SOUTH KOREA | 16 |
| SPAIN | 15 |
| SWEDEN | 35 |
| TAIWAN | 5 |
| UNITED KINGDOM | 7 |
| UNITED STATES | 331 |
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Plan to share: Yes — The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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