Trial Outcomes & Findings for A Study of Aticaprant as Adjunctive Therapy in Adult Participants With Major Depressive Disorder (MDD) With Moderate-to-severe Anhedonia and Inadequate Response to Current Antidepressant Therapy (NCT NCT05455684)

Last Updated: 2025-11-06

Results Overview

The MADRS is 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 indicates improvement.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

513 participants

Primary outcome timeframe

Baseline (Day 1) to Day 43

Results posted on

2025-11-06

Participant Flow

Adult participants aged 18 to 64 years who had major depressive disorder (MDD) with or without moderate-to-severe anhedonia (ANH+ or ANH-) and elderly participants aged 65 to 74 years with MDD (ANH+ and ANH-) who had an inadequate response to an ongoing antidepressant therapy were randomized in the study.

Participant milestones

Participant milestones
Measure	Placebo During DB treatment phase, participants received placebo matching to aticaprant tablet orally once daily from Day 1 to Day 42 in addition to the ongoing antidepressant therapy (selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor \[SSRI/SNRI\]). Participants were then followed up for safety up to 7 to 14 days after end of DB phase at Day 43 (up to Day 57). Participants who completed the DB phase (at Day 43) and were compliant to the study intervention were eligible to participate in a separate 52-week open-label long-term safety study 67953964MDD3003 (NCT05518149).	Aticaprant 10 mg During DB treatment phase, participants received aticaprant 10 mg tablet orally once daily from Day 1 to Day 42 in addition to the ongoing antidepressant therapy (SSRI/SNRI). Participants were then followed up for safety up to 7 to 14 days after end of DB phase at Day 43 (up to Day 57). Participants who completed the DB phase (at Day 43) and were compliant to the study intervention were eligible to participate in a separate 52-week open-label long-term safety study 67953964MDD3003 (NCT05518149).
Overall Study STARTED	259	254
Overall Study Safety Analysis Set	258	253
Overall Study Participants Who Entered Follow-up Phase	24	14
Overall Study COMPLETED	244	240
Overall Study NOT COMPLETED	15	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo During DB treatment phase, participants received placebo matching to aticaprant tablet orally once daily from Day 1 to Day 42 in addition to the ongoing antidepressant therapy (selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor \[SSRI/SNRI\]). Participants were then followed up for safety up to 7 to 14 days after end of DB phase at Day 43 (up to Day 57). Participants who completed the DB phase (at Day 43) and were compliant to the study intervention were eligible to participate in a separate 52-week open-label long-term safety study 67953964MDD3003 (NCT05518149).	Aticaprant 10 mg During DB treatment phase, participants received aticaprant 10 mg tablet orally once daily from Day 1 to Day 42 in addition to the ongoing antidepressant therapy (SSRI/SNRI). Participants were then followed up for safety up to 7 to 14 days after end of DB phase at Day 43 (up to Day 57). Participants who completed the DB phase (at Day 43) and were compliant to the study intervention were eligible to participate in a separate 52-week open-label long-term safety study 67953964MDD3003 (NCT05518149).
Overall Study Withdrawal by Subject	7	4
Overall Study Lost to Follow-up	3	3
Overall Study Adverse Event	2	3
Overall Study Protocol Violation	1	1
Overall Study Non-Compliant with study drug	0	1
Overall Study Other	1	2
Overall Study Randomized but not treated	1	0

Baseline Characteristics

A Study of Aticaprant as Adjunctive Therapy in Adult Participants With Major Depressive Disorder (MDD) With Moderate-to-severe Anhedonia and Inadequate Response to Current Antidepressant Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=258 Participants During DB treatment phase, participants received placebo matching to aticaprant tablet orally once daily from Day 1 to Day 42 in addition to the ongoing antidepressant therapy (SSRI/SNRI). Participants were then followed up for safety up to 7 to 14 days after end of DB phase at Day 43 (up to Day 57). Participants who completed the DB phase (at Day 43) and were compliant to the study intervention were eligible to participate in a separate 52-week open-label long-term safety study 67953964MDD3003 (NCT05518149).	Aticaprant 10 mg n=253 Participants During DB treatment phase, participants received aticaprant 10 mg tablet orally once daily from Day 1 to Day 42 in addition to the ongoing antidepressant therapy (SSRI/SNRI). Participants were then followed up for safety up to 7 to 14 days after end of DB phase at Day 43 (up to Day 57). Participants who completed the DB phase (at Day 43) and were compliant to the study intervention were eligible to participate in a separate 52-week open-label long-term safety study 67953964MDD3003 (NCT05518149).	Total n=511 Participants Total of all reporting groups
Age, Continuous	51.4 Years STANDARD_DEVIATION 13.3 • n=49 Participants	50.2 Years STANDARD_DEVIATION 14.6 • n=50 Participants	50.8 Years STANDARD_DEVIATION 13.73 • n=50 Participants
Age, Customized <18 years	0 Participants n=49 Participants	0 Participants n=50 Participants	0 Participants n=50 Participants
Age, Customized Between 18 and 64 years	213 Participants n=49 Participants	212 Participants n=50 Participants	425 Participants n=50 Participants
Age, Customized Between 65 to 74 years	45 Participants n=49 Participants	41 Participants n=50 Participants	86 Participants n=50 Participants
Sex/Gender, Customized Female	185 Participants n=49 Participants	184 Participants n=50 Participants	369 Participants n=50 Participants
Sex/Gender, Customized Male	72 Participants n=49 Participants	69 Participants n=50 Participants	141 Participants n=50 Participants
Sex/Gender, Customized Undifferentiated	1 Participants n=49 Participants	0 Participants n=50 Participants	1 Participants n=50 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	73 Participants n=49 Participants	71 Participants n=50 Participants	144 Participants n=50 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	179 Participants n=49 Participants	176 Participants n=50 Participants	355 Participants n=50 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	6 Participants n=49 Participants	6 Participants n=50 Participants	12 Participants n=50 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 Participants n=49 Participants	0 Participants n=50 Participants	1 Participants n=50 Participants
Race/Ethnicity, Customized Asian	1 Participants n=49 Participants	4 Participants n=50 Participants	5 Participants n=50 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	5 Participants n=49 Participants	3 Participants n=50 Participants	8 Participants n=50 Participants
Race/Ethnicity, Customized Black or African American	25 Participants n=49 Participants	24 Participants n=50 Participants	49 Participants n=50 Participants
Race/Ethnicity, Customized White	222 Participants n=49 Participants	213 Participants n=50 Participants	435 Participants n=50 Participants
Race/Ethnicity, Customized More than one race	1 Participants n=49 Participants	1 Participants n=50 Participants	2 Participants n=50 Participants
Race/Ethnicity, Customized Missing or Not reported	3 Participants n=49 Participants	8 Participants n=50 Participants	11 Participants n=50 Participants
Region of Enrollment Argentina	18 Participants n=49 Participants	16 Participants n=50 Participants	34 Participants n=50 Participants
Region of Enrollment Australia	6 Participants n=49 Participants	7 Participants n=50 Participants	13 Participants n=50 Participants
Region of Enrollment Belgium	12 Participants n=49 Participants	12 Participants n=50 Participants	24 Participants n=50 Participants
Region of Enrollment Brazil	23 Participants n=49 Participants	18 Participants n=50 Participants	41 Participants n=50 Participants
Region of Enrollment Bulgaria	17 Participants n=49 Participants	16 Participants n=50 Participants	33 Participants n=50 Participants
Region of Enrollment Czech Republic	20 Participants n=49 Participants	18 Participants n=50 Participants	38 Participants n=50 Participants
Region of Enrollment Hungary	2 Participants n=49 Participants	4 Participants n=50 Participants	6 Participants n=50 Participants
Region of Enrollment Italy	2 Participants n=49 Participants	1 Participants n=50 Participants	3 Participants n=50 Participants
Region of Enrollment Poland	14 Participants n=49 Participants	17 Participants n=50 Participants	31 Participants n=50 Participants
Region of Enrollment Portugal	2 Participants n=49 Participants	3 Participants n=50 Participants	5 Participants n=50 Participants
Region of Enrollment Spain	7 Participants n=49 Participants	9 Participants n=50 Participants	16 Participants n=50 Participants
Region of Enrollment Sweden	19 Participants n=49 Participants	18 Participants n=50 Participants	37 Participants n=50 Participants
Region of Enrollment United States	116 Participants n=49 Participants	114 Participants n=50 Participants	230 Participants n=50 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1) to Day 43

Population: Full analysis set (ANH+) included all adult randomized participants with MDD ANH+ who received at least 1 dose of study intervention. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Placebo n=155 Participants During DB treatment phase, participants received placebo matching to aticaprant tablet orally once daily from Day 1 to Day 42 in addition to the ongoing antidepressant therapy (SSRI/SNRI). Participants were then followed up for safety up to 7 to 14 days after end of DB phase at Day 43 (up to Day 57). Participants who completed the DB phase (at Day 43) and were compliant to the study intervention were eligible to participate in a separate 52-week open-label long-term safety study 67953964MDD3003 (NCT05518149).	Aticaprant 10 mg n=158 Participants During DB treatment phase, participants received aticaprant 10 mg tablet orally once daily from Day 1 to Day 42 in addition to the ongoing antidepressant therapy (SSRI/SNRI). Participants were then followed up for safety up to 7 to 14 days after end of DB phase at Day 43 (up to Day 57). Participants who completed the DB phase (at Day 43) and were compliant to the study intervention were eligible to participate in a separate 52-week open-label long-term safety study 67953964MDD3003 (NCT05518149).
Change From Baseline to Day 43 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score	-11.4 Units on a scale Standard Error 0.98	-12.3 Units on a scale Standard Error 0.95

SECONDARY outcome

Timeframe: Baseline (Day 1) to Day 43

The DARS is 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 is rated on a 5-point Likert scale (0=not at all, 1=slightly, 2=moderately, 3=mostly, 4=very much) and responses are summed to generate the total score (ranges from 0 to 68). A lower total score is indicative of greater anhedonia. Positive changes in DARS total score indicate improvement.

Outcome measures

Outcome measures
Measure	Placebo n=139 Participants During DB treatment phase, participants received placebo matching to aticaprant tablet orally once daily from Day 1 to Day 42 in addition to the ongoing antidepressant therapy (SSRI/SNRI). Participants were then followed up for safety up to 7 to 14 days after end of DB phase at Day 43 (up to Day 57). Participants who completed the DB phase (at Day 43) and were compliant to the study intervention were eligible to participate in a separate 52-week open-label long-term safety study 67953964MDD3003 (NCT05518149).	Aticaprant 10 mg n=147 Participants During DB treatment phase, participants received aticaprant 10 mg tablet orally once daily from Day 1 to Day 42 in addition to the ongoing antidepressant therapy (SSRI/SNRI). Participants were then followed up for safety up to 7 to 14 days after end of DB phase at Day 43 (up to Day 57). Participants who completed the DB phase (at Day 43) and were compliant to the study intervention were eligible to participate in a separate 52-week open-label long-term safety study 67953964MDD3003 (NCT05518149).
Change From Baseline to Day 43 in Dimensional Anhedonia Rating Scale (DARS) Total Score	10.5 Units on a scale Standard Error 1.50	12.0 Units on a scale Standard Error 1.43

SECONDARY outcome

Timeframe: Baseline (Day 1), Days 15, 29 and 43

Population: Full analysis set (ANH+) included all adult randomized participants with MDD ANH+ who received at least 1 dose of study intervention. Here, 'N' (overall number of participants analyzed) signifies participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants analyzed at specified timepoints.

Change from baseline over time in MADRS total score is reported. The MADRS is 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 indicates improvement.

Outcome measures

Outcome measures
Measure	Placebo n=163 Participants During DB treatment phase, participants received placebo matching to aticaprant tablet orally once daily from Day 1 to Day 42 in addition to the ongoing antidepressant therapy (SSRI/SNRI). Participants were then followed up for safety up to 7 to 14 days after end of DB phase at Day 43 (up to Day 57). Participants who completed the DB phase (at Day 43) and were compliant to the study intervention were eligible to participate in a separate 52-week open-label long-term safety study 67953964MDD3003 (NCT05518149).	Aticaprant 10 mg n=166 Participants During DB treatment phase, participants received aticaprant 10 mg tablet orally once daily from Day 1 to Day 42 in addition to the ongoing antidepressant therapy (SSRI/SNRI). Participants were then followed up for safety up to 7 to 14 days after end of DB phase at Day 43 (up to Day 57). Participants who completed the DB phase (at Day 43) and were compliant to the study intervention were eligible to participate in a separate 52-week open-label long-term safety study 67953964MDD3003 (NCT05518149).
Change From Baseline Over Time in MADRS Total Score At Day 15	-5.4 Units on a scale Standard Error 0.76	-6.6 Units on a scale Standard Error 0.72
Change From Baseline Over Time in MADRS Total Score At Day 29	-9.4 Units on a scale Standard Error 0.90	-11.1 Units on a scale Standard Error 0.87
Change From Baseline Over Time in MADRS Total Score At Day 43	-11.4 Units on a scale Standard Error 0.98	-12.3 Units on a scale Standard Error 0.95

SECONDARY outcome

Timeframe: At Day 43

Population: Full analysis set (ANH+) included all adult randomized participants with MDD ANH+ who received at least 1 dose of study intervention.

Percentage of participants who achieved response on depressive symptoms scale based on MADRS total score at Day 43 are reported. Responders are defined as participants with a \>=50 percent (%) improvement in the MADRS total score from baseline to a given timepoint. The MADRS is 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.

Outcome measures

Outcome measures
Measure	Placebo n=167 Participants During DB treatment phase, participants received placebo matching to aticaprant tablet orally once daily from Day 1 to Day 42 in addition to the ongoing antidepressant therapy (SSRI/SNRI). Participants were then followed up for safety up to 7 to 14 days after end of DB phase at Day 43 (up to Day 57). Participants who completed the DB phase (at Day 43) and were compliant to the study intervention were eligible to participate in a separate 52-week open-label long-term safety study 67953964MDD3003 (NCT05518149).	Aticaprant 10 mg n=170 Participants During DB treatment phase, participants received aticaprant 10 mg tablet orally once daily from Day 1 to Day 42 in addition to the ongoing antidepressant therapy (SSRI/SNRI). Participants were then followed up for safety up to 7 to 14 days after end of DB phase at Day 43 (up to Day 57). Participants who completed the DB phase (at Day 43) and were compliant to the study intervention were eligible to participate in a separate 52-week open-label long-term safety study 67953964MDD3003 (NCT05518149).
Percentage of Participants Who Achieved Response on Depressive Symptoms Scale Based on MADRS Total Score at Day 43	22.8 Percentage of participants	29.4 Percentage of participants

SECONDARY outcome

Timeframe: At Day 43

Population: Full analysis set (ANH+) included all adult randomized participants with MDD ANH+ who received at least 1 dose of study intervention.

Percentage of participants with remission of depressive symptoms based on MADRS total score at Day 43 is reported. Participant is defined as a remitter at a given time point if the MADRS total score is less than or equal to (\<=)10 at that time point. The MADRS is 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.

Outcome measures

Outcome measures
Measure	Placebo n=167 Participants During DB treatment phase, participants received placebo matching to aticaprant tablet orally once daily from Day 1 to Day 42 in addition to the ongoing antidepressant therapy (SSRI/SNRI). Participants were then followed up for safety up to 7 to 14 days after end of DB phase at Day 43 (up to Day 57). Participants who completed the DB phase (at Day 43) and were compliant to the study intervention were eligible to participate in a separate 52-week open-label long-term safety study 67953964MDD3003 (NCT05518149).	Aticaprant 10 mg n=170 Participants During DB treatment phase, participants received aticaprant 10 mg tablet orally once daily from Day 1 to Day 42 in addition to the ongoing antidepressant therapy (SSRI/SNRI). Participants were then followed up for safety up to 7 to 14 days after end of DB phase at Day 43 (up to Day 57). Participants who completed the DB phase (at Day 43) and were compliant to the study intervention were eligible to participate in a separate 52-week open-label long-term safety study 67953964MDD3003 (NCT05518149).
Percentage of Participants With Remission of Depressive Symptoms Based on MADRS Total Score at Day 43	12.6 Percentage of participants	17.6 Percentage of participants

SECONDARY outcome

Timeframe: Baseline (Day 1) to Day 43

Change from baseline to Day 43 in PHQ-9 total score is reported. The PHQ-9 is 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 is 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 is 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 indicate improvement.

Outcome measures

Outcome measures
Measure	Placebo n=141 Participants During DB treatment phase, participants received placebo matching to aticaprant tablet orally once daily from Day 1 to Day 42 in addition to the ongoing antidepressant therapy (SSRI/SNRI). Participants were then followed up for safety up to 7 to 14 days after end of DB phase at Day 43 (up to Day 57). Participants who completed the DB phase (at Day 43) and were compliant to the study intervention were eligible to participate in a separate 52-week open-label long-term safety study 67953964MDD3003 (NCT05518149).	Aticaprant 10 mg n=149 Participants During DB treatment phase, participants received aticaprant 10 mg tablet orally once daily from Day 1 to Day 42 in addition to the ongoing antidepressant therapy (SSRI/SNRI). Participants were then followed up for safety up to 7 to 14 days after end of DB phase at Day 43 (up to Day 57). Participants who completed the DB phase (at Day 43) and were compliant to the study intervention were eligible to participate in a separate 52-week open-label long-term safety study 67953964MDD3003 (NCT05518149).
Change From Baseline to Day 43 in Patient Health Questionnaire, 9-Item (PHQ-9) Total Score	-5.9 Units on a scale Standard Error 0.58	-6.7 Units on a scale Standard Error 0.55

SECONDARY outcome

Timeframe: Baseline (Day 1), Days 15, 29, and 43

Population: Full analysis set (ANH+) included all adult randomized participants with MDD ANH+ who received at least 1 dose of study intervention. Here, 'N' (overall number of participants analyzed) signifies participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants who were analyzed at specified timepoints.

Change from baseline over time in DARS total score is reported. The DARS is 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 is rated on a 5-point Likert scale (0=not at all, 1=slightly, 2=moderately, 3=mostly, 4=very much) and responses are summed to generate the total score (range of 0 to 68). A lower total score is indicative of greater anhedonia. Positive changes in DARS total score indicate improvement.

Outcome measures

Outcome measures
Measure	Placebo n=152 Participants During DB treatment phase, participants received placebo matching to aticaprant tablet orally once daily from Day 1 to Day 42 in addition to the ongoing antidepressant therapy (SSRI/SNRI). Participants were then followed up for safety up to 7 to 14 days after end of DB phase at Day 43 (up to Day 57). Participants who completed the DB phase (at Day 43) and were compliant to the study intervention were eligible to participate in a separate 52-week open-label long-term safety study 67953964MDD3003 (NCT05518149).	Aticaprant 10 mg n=147 Participants During DB treatment phase, participants received aticaprant 10 mg tablet orally once daily from Day 1 to Day 42 in addition to the ongoing antidepressant therapy (SSRI/SNRI). Participants were then followed up for safety up to 7 to 14 days after end of DB phase at Day 43 (up to Day 57). Participants who completed the DB phase (at Day 43) and were compliant to the study intervention were eligible to participate in a separate 52-week open-label long-term safety study 67953964MDD3003 (NCT05518149).
Change From Baseline Over Time in DARS Total Score At Day 15	4.8 Units on a scale Standard Error 1.22	5.9 Units on a scale Standard Error 1.20
Change From Baseline Over Time in DARS Total Score At Day 29	8.3 Units on a scale Standard Error 1.38	10.0 Units on a scale Standard Error 1.32
Change From Baseline Over Time in DARS Total Score At Day 43	10.5 Units on a scale Standard Error 1.50	12.0 Units on a scale Standard Error 1.43

SECONDARY outcome

Timeframe: Baseline (Day 1), Day 15, Day 29, and Day 43

Population: Full analysis set (ANH+) included all adult randomized participants with MDD ANH+ who received at least 1 dose of study intervention. Here, 'N' (overall number of participants analyzed) signifies participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants who were analyzed at specified timepoints.

Change from baseline over time in the PHQ-9 anhedonia-specific item (PHQ-9, item 1 is little interest or pleasure in doing things) is reported. The PHQ-9 is 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 is 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 is 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 indicate improvement.

Outcome measures

Outcome measures
Measure	Placebo n=154 Participants During DB treatment phase, participants received placebo matching to aticaprant tablet orally once daily from Day 1 to Day 42 in addition to the ongoing antidepressant therapy (SSRI/SNRI). Participants were then followed up for safety up to 7 to 14 days after end of DB phase at Day 43 (up to Day 57). Participants who completed the DB phase (at Day 43) and were compliant to the study intervention were eligible to participate in a separate 52-week open-label long-term safety study 67953964MDD3003 (NCT05518149).	Aticaprant 10 mg n=149 Participants During DB treatment phase, participants received aticaprant 10 mg tablet orally once daily from Day 1 to Day 42 in addition to the ongoing antidepressant therapy (SSRI/SNRI). Participants were then followed up for safety up to 7 to 14 days after end of DB phase at Day 43 (up to Day 57). Participants who completed the DB phase (at Day 43) and were compliant to the study intervention were eligible to participate in a separate 52-week open-label long-term safety study 67953964MDD3003 (NCT05518149).
Change From Baseline Over Time in the PHQ-9 Anhedonia-specific Item (PHQ-9, Item 1) At Day 15	-0.4 Units on a scale Standard Deviation 1.04	-0.5 Units on a scale Standard Deviation 1.07
Change From Baseline Over Time in the PHQ-9 Anhedonia-specific Item (PHQ-9, Item 1) At Day 29	-0.5 Units on a scale Standard Deviation 1.04	-0.8 Units on a scale Standard Deviation 1.05
Change From Baseline Over Time in the PHQ-9 Anhedonia-specific Item (PHQ-9, Item 1) At Day 43	-0.7 Units on a scale Standard Deviation 1.09	-1.0 Units on a scale Standard Deviation 1.09

SECONDARY outcome

Timeframe: At Day 43

Percentage of participants with a score \<2 in the PHQ-9 anhedonia-specific item (PHQ-9, item 1 is little interest or pleasure in doing things) at Day 43 is reported. The PHQ-9 is 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 is 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 is categorized as follows: none-minimal (0-4), mild (5-9), moderate (10-14), moderately severe (15-19) and severe (20-27).

Outcome measures

Outcome measures
Measure	Placebo n=119 Participants During DB treatment phase, participants received placebo matching to aticaprant tablet orally once daily from Day 1 to Day 42 in addition to the ongoing antidepressant therapy (SSRI/SNRI). Participants were then followed up for safety up to 7 to 14 days after end of DB phase at Day 43 (up to Day 57). Participants who completed the DB phase (at Day 43) and were compliant to the study intervention were eligible to participate in a separate 52-week open-label long-term safety study 67953964MDD3003 (NCT05518149).	Aticaprant 10 mg n=128 Participants During DB treatment phase, participants received aticaprant 10 mg tablet orally once daily from Day 1 to Day 42 in addition to the ongoing antidepressant therapy (SSRI/SNRI). Participants were then followed up for safety up to 7 to 14 days after end of DB phase at Day 43 (up to Day 57). Participants who completed the DB phase (at Day 43) and were compliant to the study intervention were eligible to participate in a separate 52-week open-label long-term safety study 67953964MDD3003 (NCT05518149).
Percentage of Participants With a Score Less Than (<) 2 in the PHQ-9 Anhedonia-specific Item (PHQ-9, Item 1) at Day 43	41.2 Percentage of participants	52.3 Percentage of participants

SECONDARY outcome

Timeframe: Baseline (Day 1), Days 15, 29, and 43

Population: Full analysis set (ANH+) included all adult randomized participants with MDD ANH+ who received at least 1 dose of study intervention. Here, 'N' (overall number of participants analyzed) signifies participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants analyzed at specified timepoints.

Change from baseline over time in the PROMIS-APS 8a is reported. This 8-item measure assesses participants' ability to participate in social roles and activities. The items measures the degree of involvement in social roles, activities, and responsibilities, including work, family, friends, and leisure. Each item is rated on a 5-point ordinal scale including 1=always, 2=usually, 3=sometimes, 4=rarely and 5=never, with higher scores indicating better social functioning. The total scores of PROMIS-APS 8a ranges from 8 to 40 and is transformed using a T-score metric with a mean of 50 and a standard deviation of 10. T-score ranges from 25.9 to 65.4, a higher score indicates better social functioning. Positive change in score indicates improvement.

Outcome measures

Outcome measures
Measure	Placebo n=145 Participants During DB treatment phase, participants received placebo matching to aticaprant tablet orally once daily from Day 1 to Day 42 in addition to the ongoing antidepressant therapy (SSRI/SNRI). Participants were then followed up for safety up to 7 to 14 days after end of DB phase at Day 43 (up to Day 57). Participants who completed the DB phase (at Day 43) and were compliant to the study intervention were eligible to participate in a separate 52-week open-label long-term safety study 67953964MDD3003 (NCT05518149).	Aticaprant 10 mg n=150 Participants During DB treatment phase, participants received aticaprant 10 mg tablet orally once daily from Day 1 to Day 42 in addition to the ongoing antidepressant therapy (SSRI/SNRI). Participants were then followed up for safety up to 7 to 14 days after end of DB phase at Day 43 (up to Day 57). Participants who completed the DB phase (at Day 43) and were compliant to the study intervention were eligible to participate in a separate 52-week open-label long-term safety study 67953964MDD3003 (NCT05518149).
Change From Baseline Over Time in Patient Reported Outcomes Measurement Information System Short Form - Ability to Participate in Social Roles and Activities - 8a (PROMIS-APS 8a) At Day 15	2.3 T-score Standard Error 0.48	2.6 T-score Standard Error 0.46
Change From Baseline Over Time in Patient Reported Outcomes Measurement Information System Short Form - Ability to Participate in Social Roles and Activities - 8a (PROMIS-APS 8a) At Day 29	2.8 T-score Standard Error 0.54	3.9 T-score Standard Error 0.52
Change From Baseline Over Time in Patient Reported Outcomes Measurement Information System Short Form - Ability to Participate in Social Roles and Activities - 8a (PROMIS-APS 8a) At Day 43	4.3 T-score Standard Error 0.63	5.5 T-score Standard Error 0.61

SECONDARY outcome

Timeframe: Baseline (Day 1), Days 29 and 43

Population: Full analysis set (ANH+) included all adult randomized participants with MDD ANH+ who received at least 1 dose of study intervention. As planned overall work impairment (absenteeism plus presenteeism) and activity impairment is reported. Here, 'N' (overall number of participants analyzed) signifies participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants who were analyzed at specified timepoints.

The WPAI:D questionnaire is a validated short instrument that assesses impairment in work and other regular activities over the past 7 days. The WPAI yields four types of scores: (a) Absenteeism (work time missed); (b) Presenteeism (impairment at work / reduced on-the-job effectiveness); (c) Work productivity loss (overall work impairment / absenteeism plus presenteeism); (d) Activity Impairment. The first three scores are derived only for respondents who were working (should be missing for non-working), but the last score is applicable for all respondents. Each score ranges from 0 to 100 with higher scores indicating greater impairment and less productivity. Negative changes in score indicates less impairment and greater productivity.

Outcome measures

Outcome measures
Measure	Placebo n=149 Participants During DB treatment phase, participants received placebo matching to aticaprant tablet orally once daily from Day 1 to Day 42 in addition to the ongoing antidepressant therapy (SSRI/SNRI). Participants were then followed up for safety up to 7 to 14 days after end of DB phase at Day 43 (up to Day 57). Participants who completed the DB phase (at Day 43) and were compliant to the study intervention were eligible to participate in a separate 52-week open-label long-term safety study 67953964MDD3003 (NCT05518149).	Aticaprant 10 mg n=154 Participants During DB treatment phase, participants received aticaprant 10 mg tablet orally once daily from Day 1 to Day 42 in addition to the ongoing antidepressant therapy (SSRI/SNRI). Participants were then followed up for safety up to 7 to 14 days after end of DB phase at Day 43 (up to Day 57). Participants who completed the DB phase (at Day 43) and were compliant to the study intervention were eligible to participate in a separate 52-week open-label long-term safety study 67953964MDD3003 (NCT05518149).
Percent Change From Baseline Over Time in Work Productivity and Activity Impairment: Depression (WPAI:D) Overall work impairment: Day 29	-5.8 Percent Change Standard Error 4.59	-14.2 Percent Change Standard Error 4.71
Percent Change From Baseline Over Time in Work Productivity and Activity Impairment: Depression (WPAI:D) Overall work impairment: Day 43	-13.9 Percent Change Standard Error 5.07	-12.9 Percent Change Standard Error 5.09
Percent Change From Baseline Over Time in Work Productivity and Activity Impairment: Depression (WPAI:D) Activity impairment: Day29	-9.2 Percent Change Standard Error 2.12	-13.9 Percent Change Standard Error 2.03
Percent Change From Baseline Over Time in Work Productivity and Activity Impairment: Depression (WPAI:D) Activity impairment: Day43	-13.9 Percent Change Standard Error 2.28	-18.1 Percent Change Standard Error 2.20

SECONDARY outcome

Timeframe: From start of treatment (Day 1) up to Day 43

Population: Safety analysis set included all randomized participants (adults and elderly) who received at least 1 dose of study intervention.

Percentage of participants with TEAEs during DB treatment phase are reported. A TEAE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. A TEAE does not necessarily have a causal relationship with the intervention. TEAEs included both serious and non serious adverse events. TEAEs were defined as AEs with onset during the DB Treatment Phase, or AEs that are a consequence of a pre-existing condition that has worsened since baseline (Day 1).

Outcome measures

Outcome measures
Measure	Placebo n=258 Participants During DB treatment phase, participants received placebo matching to aticaprant tablet orally once daily from Day 1 to Day 42 in addition to the ongoing antidepressant therapy (SSRI/SNRI). Participants were then followed up for safety up to 7 to 14 days after end of DB phase at Day 43 (up to Day 57). Participants who completed the DB phase (at Day 43) and were compliant to the study intervention were eligible to participate in a separate 52-week open-label long-term safety study 67953964MDD3003 (NCT05518149).	Aticaprant 10 mg n=253 Participants During DB treatment phase, participants received aticaprant 10 mg tablet orally once daily from Day 1 to Day 42 in addition to the ongoing antidepressant therapy (SSRI/SNRI). Participants were then followed up for safety up to 7 to 14 days after end of DB phase at Day 43 (up to Day 57). Participants who completed the DB phase (at Day 43) and were compliant to the study intervention were eligible to participate in a separate 52-week open-label long-term safety study 67953964MDD3003 (NCT05518149).
DB Treatment Phase: Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)	39.5 Percentage of participants	45.8 Percentage of participants

SECONDARY outcome

Timeframe: From Day 44 up to Day 57

Population: Follow-up analysis set included all randomized participants who entered the follow-up phase after the double-blind treatment phase.

An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention.

Outcome measures

Outcome measures
Measure	Placebo n=24 Participants During DB treatment phase, participants received placebo matching to aticaprant tablet orally once daily from Day 1 to Day 42 in addition to the ongoing antidepressant therapy (SSRI/SNRI). Participants were then followed up for safety up to 7 to 14 days after end of DB phase at Day 43 (up to Day 57). Participants who completed the DB phase (at Day 43) and were compliant to the study intervention were eligible to participate in a separate 52-week open-label long-term safety study 67953964MDD3003 (NCT05518149).	Aticaprant 10 mg n=14 Participants During DB treatment phase, participants received aticaprant 10 mg tablet orally once daily from Day 1 to Day 42 in addition to the ongoing antidepressant therapy (SSRI/SNRI). Participants were then followed up for safety up to 7 to 14 days after end of DB phase at Day 43 (up to Day 57). Participants who completed the DB phase (at Day 43) and were compliant to the study intervention were eligible to participate in a separate 52-week open-label long-term safety study 67953964MDD3003 (NCT05518149).
Follow-up (FU) Phase: Percentage of Participants With AEs	8.3 Percentage of participants	7.1 Percentage of participants

Adverse Events

DB: Placebo

Serious events: 1 serious events

Other events: 34 other events

Deaths: 0 deaths

DB: Aticaprant 10 mg

Serious events: 3 serious events

Other events: 54 other events

Deaths: 0 deaths

FU: Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

FU: Aticaprant

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	DB: Placebo n=258 participants at risk During DB treatment phase, participants received placebo matching to aticaprant tablet orally once daily from Day 1 to Day 42 in addition to the ongoing antidepressant therapy (SSRI/SNRI).	DB: Aticaprant 10 mg n=253 participants at risk During the DB treatment phase, participants received aticaprant 10 mg tablet orally once daily from Day 1 to Day 42 in addition to the ongoing antidepressant therapy (SSRI/SNRI).	FU: Placebo n=24 participants at risk Participants who received placebo and completed DB phase entered follow-up phase and were then followed up for safety up to 7 to 14 days after end of DB phase at Day 43 (up to Day 57).	FU: Aticaprant n=14 participants at risk Participants who received aticaprant 10 mg and completed DB phase entered follow-up phase and were then followed up for safety up to 7 to 14 days after end of DB phase at Day 43 (up to Day 57).
Gastrointestinal disorders Pancreatitis Acute	0.00% 0/258 • DB treatment phase: start of treatment (Day 1) up to Day 43, FU Phase: From Day 44 up to Day 57 DB phase: Safety analysis set included all randomized participants (adults and elderly) who received at least 1 dose of study treatment. FU phase population included all randomized participants who entered the FU phase after the double-blind treatment phase.	0.40% 1/253 • DB treatment phase: start of treatment (Day 1) up to Day 43, FU Phase: From Day 44 up to Day 57 DB phase: Safety analysis set included all randomized participants (adults and elderly) who received at least 1 dose of study treatment. FU phase population included all randomized participants who entered the FU phase after the double-blind treatment phase.	0.00% 0/24 • DB treatment phase: start of treatment (Day 1) up to Day 43, FU Phase: From Day 44 up to Day 57 DB phase: Safety analysis set included all randomized participants (adults and elderly) who received at least 1 dose of study treatment. FU phase population included all randomized participants who entered the FU phase after the double-blind treatment phase.	0.00% 0/14 • DB treatment phase: start of treatment (Day 1) up to Day 43, FU Phase: From Day 44 up to Day 57 DB phase: Safety analysis set included all randomized participants (adults and elderly) who received at least 1 dose of study treatment. FU phase population included all randomized participants who entered the FU phase after the double-blind treatment phase.
Infections and infestations Pneumonia	0.39% 1/258 • DB treatment phase: start of treatment (Day 1) up to Day 43, FU Phase: From Day 44 up to Day 57 DB phase: Safety analysis set included all randomized participants (adults and elderly) who received at least 1 dose of study treatment. FU phase population included all randomized participants who entered the FU phase after the double-blind treatment phase.	0.00% 0/253 • DB treatment phase: start of treatment (Day 1) up to Day 43, FU Phase: From Day 44 up to Day 57 DB phase: Safety analysis set included all randomized participants (adults and elderly) who received at least 1 dose of study treatment. FU phase population included all randomized participants who entered the FU phase after the double-blind treatment phase.	0.00% 0/24 • DB treatment phase: start of treatment (Day 1) up to Day 43, FU Phase: From Day 44 up to Day 57 DB phase: Safety analysis set included all randomized participants (adults and elderly) who received at least 1 dose of study treatment. FU phase population included all randomized participants who entered the FU phase after the double-blind treatment phase.	0.00% 0/14 • DB treatment phase: start of treatment (Day 1) up to Day 43, FU Phase: From Day 44 up to Day 57 DB phase: Safety analysis set included all randomized participants (adults and elderly) who received at least 1 dose of study treatment. FU phase population included all randomized participants who entered the FU phase after the double-blind treatment phase.
Psychiatric disorders Suicidal Behaviour	0.00% 0/258 • DB treatment phase: start of treatment (Day 1) up to Day 43, FU Phase: From Day 44 up to Day 57 DB phase: Safety analysis set included all randomized participants (adults and elderly) who received at least 1 dose of study treatment. FU phase population included all randomized participants who entered the FU phase after the double-blind treatment phase.	0.40% 1/253 • DB treatment phase: start of treatment (Day 1) up to Day 43, FU Phase: From Day 44 up to Day 57 DB phase: Safety analysis set included all randomized participants (adults and elderly) who received at least 1 dose of study treatment. FU phase population included all randomized participants who entered the FU phase after the double-blind treatment phase.	0.00% 0/24 • DB treatment phase: start of treatment (Day 1) up to Day 43, FU Phase: From Day 44 up to Day 57 DB phase: Safety analysis set included all randomized participants (adults and elderly) who received at least 1 dose of study treatment. FU phase population included all randomized participants who entered the FU phase after the double-blind treatment phase.	0.00% 0/14 • DB treatment phase: start of treatment (Day 1) up to Day 43, FU Phase: From Day 44 up to Day 57 DB phase: Safety analysis set included all randomized participants (adults and elderly) who received at least 1 dose of study treatment. FU phase population included all randomized participants who entered the FU phase after the double-blind treatment phase.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/258 • DB treatment phase: start of treatment (Day 1) up to Day 43, FU Phase: From Day 44 up to Day 57 DB phase: Safety analysis set included all randomized participants (adults and elderly) who received at least 1 dose of study treatment. FU phase population included all randomized participants who entered the FU phase after the double-blind treatment phase.	0.40% 1/253 • DB treatment phase: start of treatment (Day 1) up to Day 43, FU Phase: From Day 44 up to Day 57 DB phase: Safety analysis set included all randomized participants (adults and elderly) who received at least 1 dose of study treatment. FU phase population included all randomized participants who entered the FU phase after the double-blind treatment phase.	0.00% 0/24 • DB treatment phase: start of treatment (Day 1) up to Day 43, FU Phase: From Day 44 up to Day 57 DB phase: Safety analysis set included all randomized participants (adults and elderly) who received at least 1 dose of study treatment. FU phase population included all randomized participants who entered the FU phase after the double-blind treatment phase.	0.00% 0/14 • DB treatment phase: start of treatment (Day 1) up to Day 43, FU Phase: From Day 44 up to Day 57 DB phase: Safety analysis set included all randomized participants (adults and elderly) who received at least 1 dose of study treatment. FU phase population included all randomized participants who entered the FU phase after the double-blind treatment phase.

Other adverse events

Other adverse events
Measure	DB: Placebo n=258 participants at risk During DB treatment phase, participants received placebo matching to aticaprant tablet orally once daily from Day 1 to Day 42 in addition to the ongoing antidepressant therapy (SSRI/SNRI).	DB: Aticaprant 10 mg n=253 participants at risk During the DB treatment phase, participants received aticaprant 10 mg tablet orally once daily from Day 1 to Day 42 in addition to the ongoing antidepressant therapy (SSRI/SNRI).	FU: Placebo n=24 participants at risk Participants who received placebo and completed DB phase entered follow-up phase and were then followed up for safety up to 7 to 14 days after end of DB phase at Day 43 (up to Day 57).	FU: Aticaprant n=14 participants at risk Participants who received aticaprant 10 mg and completed DB phase entered follow-up phase and were then followed up for safety up to 7 to 14 days after end of DB phase at Day 43 (up to Day 57).
Gastrointestinal disorders Diarrhoea	3.1% 8/258 • DB treatment phase: start of treatment (Day 1) up to Day 43, FU Phase: From Day 44 up to Day 57 DB phase: Safety analysis set included all randomized participants (adults and elderly) who received at least 1 dose of study treatment. FU phase population included all randomized participants who entered the FU phase after the double-blind treatment phase.	5.5% 14/253 • DB treatment phase: start of treatment (Day 1) up to Day 43, FU Phase: From Day 44 up to Day 57 DB phase: Safety analysis set included all randomized participants (adults and elderly) who received at least 1 dose of study treatment. FU phase population included all randomized participants who entered the FU phase after the double-blind treatment phase.	0.00% 0/24 • DB treatment phase: start of treatment (Day 1) up to Day 43, FU Phase: From Day 44 up to Day 57 DB phase: Safety analysis set included all randomized participants (adults and elderly) who received at least 1 dose of study treatment. FU phase population included all randomized participants who entered the FU phase after the double-blind treatment phase.	0.00% 0/14 • DB treatment phase: start of treatment (Day 1) up to Day 43, FU Phase: From Day 44 up to Day 57 DB phase: Safety analysis set included all randomized participants (adults and elderly) who received at least 1 dose of study treatment. FU phase population included all randomized participants who entered the FU phase after the double-blind treatment phase.
Infections and infestations Nasopharyngitis	2.3% 6/258 • DB treatment phase: start of treatment (Day 1) up to Day 43, FU Phase: From Day 44 up to Day 57 DB phase: Safety analysis set included all randomized participants (adults and elderly) who received at least 1 dose of study treatment. FU phase population included all randomized participants who entered the FU phase after the double-blind treatment phase.	1.6% 4/253 • DB treatment phase: start of treatment (Day 1) up to Day 43, FU Phase: From Day 44 up to Day 57 DB phase: Safety analysis set included all randomized participants (adults and elderly) who received at least 1 dose of study treatment. FU phase population included all randomized participants who entered the FU phase after the double-blind treatment phase.	0.00% 0/24 • DB treatment phase: start of treatment (Day 1) up to Day 43, FU Phase: From Day 44 up to Day 57 DB phase: Safety analysis set included all randomized participants (adults and elderly) who received at least 1 dose of study treatment. FU phase population included all randomized participants who entered the FU phase after the double-blind treatment phase.	7.1% 1/14 • DB treatment phase: start of treatment (Day 1) up to Day 43, FU Phase: From Day 44 up to Day 57 DB phase: Safety analysis set included all randomized participants (adults and elderly) who received at least 1 dose of study treatment. FU phase population included all randomized participants who entered the FU phase after the double-blind treatment phase.
Nervous system disorders Headache	8.5% 22/258 • DB treatment phase: start of treatment (Day 1) up to Day 43, FU Phase: From Day 44 up to Day 57 DB phase: Safety analysis set included all randomized participants (adults and elderly) who received at least 1 dose of study treatment. FU phase population included all randomized participants who entered the FU phase after the double-blind treatment phase.	6.7% 17/253 • DB treatment phase: start of treatment (Day 1) up to Day 43, FU Phase: From Day 44 up to Day 57 DB phase: Safety analysis set included all randomized participants (adults and elderly) who received at least 1 dose of study treatment. FU phase population included all randomized participants who entered the FU phase after the double-blind treatment phase.	0.00% 0/24 • DB treatment phase: start of treatment (Day 1) up to Day 43, FU Phase: From Day 44 up to Day 57 DB phase: Safety analysis set included all randomized participants (adults and elderly) who received at least 1 dose of study treatment. FU phase population included all randomized participants who entered the FU phase after the double-blind treatment phase.	0.00% 0/14 • DB treatment phase: start of treatment (Day 1) up to Day 43, FU Phase: From Day 44 up to Day 57 DB phase: Safety analysis set included all randomized participants (adults and elderly) who received at least 1 dose of study treatment. FU phase population included all randomized participants who entered the FU phase after the double-blind treatment phase.
Skin and subcutaneous tissue disorders Pruritus	2.3% 6/258 • DB treatment phase: start of treatment (Day 1) up to Day 43, FU Phase: From Day 44 up to Day 57 DB phase: Safety analysis set included all randomized participants (adults and elderly) who received at least 1 dose of study treatment. FU phase population included all randomized participants who entered the FU phase after the double-blind treatment phase.	12.3% 31/253 • DB treatment phase: start of treatment (Day 1) up to Day 43, FU Phase: From Day 44 up to Day 57 DB phase: Safety analysis set included all randomized participants (adults and elderly) who received at least 1 dose of study treatment. FU phase population included all randomized participants who entered the FU phase after the double-blind treatment phase.	0.00% 0/24 • DB treatment phase: start of treatment (Day 1) up to Day 43, FU Phase: From Day 44 up to Day 57 DB phase: Safety analysis set included all randomized participants (adults and elderly) who received at least 1 dose of study treatment. FU phase population included all randomized participants who entered the FU phase after the double-blind treatment phase.	0.00% 0/14 • DB treatment phase: start of treatment (Day 1) up to Day 43, FU Phase: From Day 44 up to Day 57 DB phase: Safety analysis set included all randomized participants (adults and elderly) who received at least 1 dose of study treatment. FU phase population included all randomized participants who entered the FU phase after the double-blind treatment phase.

Additional Information

Executive Medical Director

Janssen Research and Development, LLC

Phone: 844-434-4210

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
Publication restrictions are in place

Restriction type: OTHER