Brief Summary
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).
Brief Title
A Study of Aticaprant in Adult and Elderly Participants With Major Depressive Disorder (MDD)
Categories
Completion Date
Completion Date Type
Actual
Conditions
DEPRESSIVE DISORDER, MAJOR
Eligibility Criteria
Inclusion Criteria:
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:
* Have a Hamilton Depression Rating Scale (HDRS)-17 total score of 20 or higher at the first and second screening interviews and must not demonstrate a clinically significant improvement (that is, an improvement of more than 20 percent (%) on their HDRS-17 total score) between the first and the second independent HDRS-17 assessments
* Have had an inadequate response to at least 1 oral antidepressant treatment, administered at an adequate dose (at or above the minimum therapeutic dose per Massachusetts general hospital antidepressant treatment response questionnaire \[MGH ATRQ\]) and duration (at least 6 weeks) in the current episode of depression
* Must be an outpatient at open-label treatment phase baseline
* Meet Diagnostic and Statistical Manual of Mental Disorders-5th Edition (DSM-5) diagnostic criteria for recurrent or single episode major depressive disorder (MDD), without psychotic features, based upon clinical assessment and confirmed by the Structured Clinical Interview for DSM-5 Axis I Disorders-Clinical Trials Version (SCID-CT)
Direct-entry and Transferred-entry Participants:
-Participants should not take any prohibited medication or food supplements
Exclusion Criteria:
Transferred-entry Participants:
* Participant has been non-compliant with the study intervention administration in the DB Treatment Phase in either of Studies 67953964MDD3001 or 67953964MDD3002 (that is, have missed either 4 or more consecutive doses of study intervention or a total of 8 or more doses during the DB Treatment Phase)
* Participant has any condition or situation/circumstance for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise the well-being) or that could prevent, limit, or confound the protocol specified assessments
Direct-entry Participants:
* Employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator
* Has a history or evidence of clinically meaningful noncompliance with current antidepressant therapy
* Known allergies, hypersensitivity, or intolerance to aticaprant or any of its excipients
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:
* Have a Hamilton Depression Rating Scale (HDRS)-17 total score of 20 or higher at the first and second screening interviews and must not demonstrate a clinically significant improvement (that is, an improvement of more than 20 percent (%) on their HDRS-17 total score) between the first and the second independent HDRS-17 assessments
* Have had an inadequate response to at least 1 oral antidepressant treatment, administered at an adequate dose (at or above the minimum therapeutic dose per Massachusetts general hospital antidepressant treatment response questionnaire \[MGH ATRQ\]) and duration (at least 6 weeks) in the current episode of depression
* Must be an outpatient at open-label treatment phase baseline
* Meet Diagnostic and Statistical Manual of Mental Disorders-5th Edition (DSM-5) diagnostic criteria for recurrent or single episode major depressive disorder (MDD), without psychotic features, based upon clinical assessment and confirmed by the Structured Clinical Interview for DSM-5 Axis I Disorders-Clinical Trials Version (SCID-CT)
Direct-entry and Transferred-entry Participants:
-Participants should not take any prohibited medication or food supplements
Exclusion Criteria:
Transferred-entry Participants:
* Participant has been non-compliant with the study intervention administration in the DB Treatment Phase in either of Studies 67953964MDD3001 or 67953964MDD3002 (that is, have missed either 4 or more consecutive doses of study intervention or a total of 8 or more doses during the DB Treatment Phase)
* Participant has any condition or situation/circumstance for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise the well-being) or that could prevent, limit, or confound the protocol specified assessments
Direct-entry Participants:
* Employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator
* Has a history or evidence of clinically meaningful noncompliance with current antidepressant therapy
* Known allergies, hypersensitivity, or intolerance to aticaprant or any of its excipients
Inclusion Criteria
Inclusion Criteria:
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:
* Have a Hamilton Depression Rating Scale (HDRS)-17 total score of 20 or higher at the first and second screening interviews and must not demonstrate a clinically significant improvement (that is, an improvement of more than 20 percent (%) on their HDRS-17 total score) between the first and the second independent HDRS-17 assessments
* Have had an inadequate response to at least 1 oral antidepressant treatment, administered at an adequate dose (at or above the minimum therapeutic dose per Massachusetts general hospital antidepressant treatment response questionnaire \[MGH ATRQ\]) and duration (at least 6 weeks) in the current episode of depression
* Must be an outpatient at open-label treatment phase baseline
* Meet Diagnostic and Statistical Manual of Mental Disorders-5th Edition (DSM-5) diagnostic criteria for recurrent or single episode major depressive disorder (MDD), without psychotic features, based upon clinical assessment and confirmed by the Structured Clinical Interview for DSM-5 Axis I Disorders-Clinical Trials Version (SCID-CT)
Direct-entry and Transferred-entry Participants:
-Participants should not take any prohibited medication or food supplements
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:
* Have a Hamilton Depression Rating Scale (HDRS)-17 total score of 20 or higher at the first and second screening interviews and must not demonstrate a clinically significant improvement (that is, an improvement of more than 20 percent (%) on their HDRS-17 total score) between the first and the second independent HDRS-17 assessments
* Have had an inadequate response to at least 1 oral antidepressant treatment, administered at an adequate dose (at or above the minimum therapeutic dose per Massachusetts general hospital antidepressant treatment response questionnaire \[MGH ATRQ\]) and duration (at least 6 weeks) in the current episode of depression
* Must be an outpatient at open-label treatment phase baseline
* Meet Diagnostic and Statistical Manual of Mental Disorders-5th Edition (DSM-5) diagnostic criteria for recurrent or single episode major depressive disorder (MDD), without psychotic features, based upon clinical assessment and confirmed by the Structured Clinical Interview for DSM-5 Axis I Disorders-Clinical Trials Version (SCID-CT)
Direct-entry and Transferred-entry Participants:
-Participants should not take any prohibited medication or food supplements
Gender
All
Gender Based
false
Keywords
Depressive Disorder, Major
Aticaprant
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
74 Years
Minimum Age
18 Years
NCT Id
NCT05518149
Org Class
Industry
Org Full Name
Janssen Research & Development, LLC
Org Study Id
CR109218
Overall Status
Terminated
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
An Open-label, Long-term, Safety and Efficacy Study of Aticaprant as Adjunctive Therapy in Adult and Elderly Participants With Major Depressive Disorder (MDD)
Primary Outcomes
Outcome Description
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.
Outcome Measure
Open Label (OL) Treatment Phase: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and AEs of Special Interest (AESI)
Outcome Time Frame
From start of open-label treatment (Day 1) up to Week 52
Outcome Description
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.
Outcome Measure
Follow-up Phase: Number of Participants With Adverse Events (AEs) and AEs of Special Interest (AESI)
Outcome Time Frame
From Week 52 to Week 54
Outcome Description
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.
Outcome Measure
Change From Baseline in Vital Sign Parameter: Blood Pressure (Systolic and Diastolic Blood Pressure)
Outcome 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])
Outcome Description
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.
Outcome Measure
Change From Baseline in Vital Sign Parameter: Pulse Rate
Outcome 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])
Outcome Description
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.
Outcome Measure
Change From Baseline in Vital Sign Parameter: Temperature
Outcome 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])
Outcome Description
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.
Outcome Measure
Change From Baseline in Vital Sign Parameter: Weight
Outcome 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])
Outcome Description
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.
Outcome Measure
Change From Baseline in Body Mass Index (BMI)
Outcome 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])
Outcome Description
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.
Outcome Measure
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)
Outcome 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)
Outcome Description
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.
Outcome Measure
Follow-up Phase: Number of Participants With Shift From Baseline in Suicidal Ideation or Suicidal Behavior as Assessed by C-SSRS
Outcome 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)
Outcome Description
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.
Outcome Measure
OL Treatment Phase: Change From Baseline in Laboratory Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase, Gamma Glutamyl Transferase
Outcome Time Frame
Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52)
Outcome Description
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.
Outcome Measure
OL Treatment Phase: Change From Baseline in Laboratory Parameters: Albumin, Protein, Erythrocyte (Ery.) Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin
Outcome Time Frame
Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52)
Outcome Description
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.
Outcome Measure
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
Outcome Time Frame
Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52)
Outcome Description
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.
Outcome Measure
OL Treatment Phase: Change From Baseline in Laboratory Parameters: Bilirubin, Creatinine, Direct Bilirubin, Indirect Bilirubin, Urate
Outcome Time Frame
Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52)
Outcome Description
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.
Outcome Measure
OL Treatment Phase: Change From Baseline in Laboratory Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets, Leukocytes
Outcome Time Frame
Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52)
Outcome Description
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.
Outcome Measure
OL Treatment Phase: Change From Baseline in Laboratory Parameter: Ery. Mean Corpuscular Hemoglobin (MCH)
Outcome Time Frame
Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52)
Outcome Description
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.
Outcome Measure
OL Treatment Phase: Change From Baseline in Laboratory Parameter: Ery. Mean Corpuscular Volume (MCV)
Outcome Time Frame
Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52)
Outcome Description
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.
Outcome Measure
OL Treatment Phase: Change From Baseline in Laboratory Parameter: Hematocrit
Outcome Time Frame
Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52)
Outcome Description
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.
Outcome Measure
OL Treatment Phase: Change From Baseline in Laboratory Parameter: Specific Gravity
Outcome Time Frame
Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52)
Outcome Description
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.
Outcome Measure
OL Treatment Phase: Change From Baseline in Laboratory Parameter: Urine pH
Outcome Time Frame
Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52)
Outcome Description
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.
Outcome Measure
OL Treatment Phase: Change From Baseline in Laboratory Parameter: Hyaline Casts
Outcome Time Frame
Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52)
Outcome Description
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.
Outcome Measure
OL Treatment Phase: Change From Baseline in Laboratory Parameter: Squamous Epithelial Cells, Transitional Epithelial Cells, Tubular Epithelial Cells, Urine Erythrocytes, Urine Leukocytes
Outcome Time Frame
Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52)
Outcome Description
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.
Outcome Measure
OL Treatment Phase: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, RR Interval, QTcB Interval, QTcF Interval
Outcome Time Frame
Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52)
Outcome Description
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.
Outcome Measure
OL Treatment Phase: Number of Participants With Withdrawal Symptoms as Assessed by Physician Withdrawal Checklist 20-item (PWC-20)
Outcome Time Frame
Endpoint (OL) (at any time between Day 2 to Week 52)
Outcome Description
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.
Outcome Measure
Follow-up Phase: Number of Participants With Withdrawal Symptoms as Assessed by Physician Withdrawal Checklist 20-item (PWC-20)
Outcome 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}])
Outcome Description
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.
Outcome Measure
OL Treatment Phase: Percentage of Participants With Clinically Relevant Sexual Dysfunction Over Time as Determined by Arizona Sexual Experiences Scale (ASEX)
Outcome Time Frame
Endpoint (OL) (at any time between Week 12 to Week 52)
Secondary Ids
Secondary Id
67953964MDD3003
Secondary Id
2022-000430-42
Secondary Id
2023-508163-74-00
Secondary Id
2023
Secondary Outcomes
Outcome Description
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.
Outcome 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}])
Outcome Measure
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Outcome Description
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.
Outcome 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}])
Outcome Measure
Change From Baseline in Patient Health Questionnaire, 9-item (PHQ-9) Total Score
Outcome Description
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.
Outcome 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}])
Outcome Measure
Change From Baseline in Dimensional Anhedonia Rating Scale (DARS) Total Score
Outcome Description
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.
Outcome 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}])
Outcome Measure
Change From Baseline in Clinical Global Impression-Severity (CGI-S) Total Score
Outcome Description
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).
Outcome 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}])
Outcome Measure
Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%) Reduction From Baseline in the MADRS Total Score
Outcome Description
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.
Outcome 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}])
Outcome Measure
Percentage of Participants With Remission of Depressive Symptoms
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
74
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Jonathan Alpert
Investigator Email
jalpert@montefiore.org
Categories Mesh Debug
Mental Health & Behavioral Research --- DEPRESSIVE DISORDER, MAJOR
Psychiatry & Behavioral Sciences --- DEPRESSIVE DISORDER, MAJOR
Mental Health & Behavioral Research --- DEPRESSIVE DISORDER
Psychiatry & Behavioral Sciences --- DEPRESSIVE DISORDER
Mental Health & Behavioral Research --- MOOD DISORDERS
Psychiatry & Behavioral Sciences --- MOOD DISORDERS
Child Development & Autism --- MENTAL DISORDERS
Mental Health & Behavioral Research --- MENTAL DISORDERS
Psychiatry & Behavioral Sciences --- MENTAL DISORDERS
Substance Use and Addiction --- MENTAL DISORDERS
MeSH Terms
DEPRESSIVE DISORDER, MAJOR
DEPRESSIVE DISORDER
MOOD DISORDERS
MENTAL DISORDERS
ATICAPRANT