Trial Outcomes & Findings for A Study of JNJ-55308942 in the Treatment of Bipolar Depression (NCT NCT05328297)

Last Updated: 2025-07-11

Results Overview

Change from baseline in MADRS total score up to Week 6 were reported. MADRS was a clinician-rated scale designed to measure depression severity and detect changes due to antidepressant (AD) treatment. The MADRS evaluated reported sadness, apparent sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. The scale consisted of 10 items, each of which was scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms),with higher score indicating a more severe condition. The MADRS total score was the sum of scores from individual question items and it ranged from 0 to 60, with higher scores indicated more severe conditions. Negative change in MADRS total score indicated improvement.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

116 participants

Primary outcome timeframe

From Baseline (Day 1) up to Week 6

Results posted on

2025-07-11

Participant Flow

Participant milestones

Participant milestones
Measure	JNJ-55308942 During double-blind (DB) treatment phase, participants received JNJ-55308942 capsule, orally once daily from Day 1 (Week 0) up to 6 weeks. Participants were then followed up for up to 2 weeks after their last dose (up to Day 56).	Placebo During DB treatment phase, participants received placebo capsule (matching to JNJ-55308942), orally once daily from Day 1 (Week 0) up to 6 weeks. Participants were then followed up for up to 2 weeks after their last dose (up to Day 56).
Overall Study STARTED	55	61
Overall Study Treated (Safety Analysis Set)	54	60
Overall Study COMPLETED	42	50
Overall Study NOT COMPLETED	13	11

Reasons for withdrawal

Reasons for withdrawal
Measure	JNJ-55308942 During double-blind (DB) treatment phase, participants received JNJ-55308942 capsule, orally once daily from Day 1 (Week 0) up to 6 weeks. Participants were then followed up for up to 2 weeks after their last dose (up to Day 56).	Placebo During DB treatment phase, participants received placebo capsule (matching to JNJ-55308942), orally once daily from Day 1 (Week 0) up to 6 weeks. Participants were then followed up for up to 2 weeks after their last dose (up to Day 56).
Overall Study Adverse Event	5	7
Overall Study Withdrawal by Subject	4	3
Overall Study Lack of Efficacy	1	0
Overall Study Lost to Follow-up	1	0
Overall Study Protocol Violation	1	0
Overall Study Randomized but not treated	1	1

Baseline Characteristics

A Study of JNJ-55308942 in the Treatment of Bipolar Depression

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	JNJ-55308942 n=54 Participants During double-blind (DB) treatment phase, participants received JNJ-55308942 capsule, orally once daily from Day 1 (Week 0) up to 6 weeks. Participants were then followed up for up to 2 weeks after their last dose (up to Day 56).	Placebo n=60 Participants During DB treatment phase, participants received placebo capsule (matching to JNJ-55308942), orally once daily from Day 1 (Week 0) up to 6 weeks. Participants were then followed up for up to 2 weeks after their last dose (up to Day 56).	Total n=114 Participants Total of all reporting groups
Age, Continuous	39.28 years STANDARD_DEVIATION 13.603 • n=5 Participants	40.18 years STANDARD_DEVIATION 12.664 • n=7 Participants	39.75 years STANDARD_DEVIATION 13.067 • n=5 Participants
Sex: Female, Male Female	38 Participants n=5 Participants	33 Participants n=7 Participants	71 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	27 Participants n=7 Participants	43 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	50 Participants n=5 Participants	53 Participants n=7 Participants	103 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) White	44 Participants n=5 Participants	50 Participants n=7 Participants	94 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment Canada	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment Poland	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants
Region of Enrollment Spain	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Region of Enrollment United States	21 Participants n=5 Participants	25 Participants n=7 Participants	46 Participants n=5 Participants

PRIMARY outcome

Timeframe: From Baseline (Day 1) up to Week 6

Population: Full analysis set (FAS) included all randomized participants who received at least 1 dose of study intervention and had both the baseline and at least 1 postbaseline MADRS measurement.

Outcome measures

Outcome measures
Measure	JNJ-55308942 n=48 Participants During double-blind (DB) treatment phase, participants received JNJ-55308942 capsule, orally once daily from Day 1 (Week 0) up to 6 weeks. Participants were then followed up for up to 2 weeks after their last dose (up to Day 56).	Placebo n=59 Participants During DB treatment phase, participants received placebo capsule (matching to JNJ-55308942), orally once daily from Day 1 (Week 0) up to 6 weeks. Participants were then followed up for up to 2 weeks after their last dose (up to Day 56).
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score up to Week 6	-16.0 Units on a scale Standard Deviation 10.43	-15.4 Units on a scale Standard Deviation 9.81

SECONDARY outcome

Timeframe: From Baseline (Day 1) up to Week 6

Population: FAS included all randomized participants who received at least 1 dose of study intervention and had both the baseline and at least 1 postbaseline MADRS measurement. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Change from baseline in SHAPS total score up to Week 6 were reported. The SHAPS was a reliable, valid, and unidimensional instrument used to assess hedonic capacity in adults with Major Depressive Disorder. It is a 14-item, self-report tool with a completion time below 5 minutes. Each of the items had a set of 4 response categories: 1 = definitely agree/strongly agree, 2 = agree, 3 = disagree, and 4 = strongly disagree. The SHAPS total score was the sum of the 14 item scores, which ranged from 14 to 56. A higher SHAPS total score indicated higher levels of current anhedonia. Negative changes in the SHAPS total score indicated improvement.

Outcome measures

Outcome measures
Measure	JNJ-55308942 n=42 Participants During double-blind (DB) treatment phase, participants received JNJ-55308942 capsule, orally once daily from Day 1 (Week 0) up to 6 weeks. Participants were then followed up for up to 2 weeks after their last dose (up to Day 56).	Placebo n=50 Participants During DB treatment phase, participants received placebo capsule (matching to JNJ-55308942), orally once daily from Day 1 (Week 0) up to 6 weeks. Participants were then followed up for up to 2 weeks after their last dose (up to Day 56).
Change From Baseline in Snaith-Hamilton Pleasure Scale (SHAPS) Total Score up to Week 6	-8.2 Units on a scale Standard Deviation 6.87	-8.3 Units on a scale Standard Deviation 8.69

SECONDARY outcome

Timeframe: From Baseline (Day 1) up to Week 6

Genetic subgroup analysis included participants with bipolar depression and who were with P2RX7 Gain of Function single nucleotide polymorphism (P2RX7 GoF SNP) mutation genotype: heterozygous or homozygous. MADRS was a clinician-rated scale designed to measure depression severity and detect changes due to AD treatment. The MADRS evaluated reported sadness, apparent sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. The scale consisted of 10 items, each of which was scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms),with higher score indicating a more severe condition. The MADRS total score was the sum of scores from individual question items and it ranged from 0 to 60, with higher scores indicated more severe conditions. Negative change in MADRS total score indicated improvement.

Outcome measures

Outcome measures
Measure	JNJ-55308942 n=42 Participants During double-blind (DB) treatment phase, participants received JNJ-55308942 capsule, orally once daily from Day 1 (Week 0) up to 6 weeks. Participants were then followed up for up to 2 weeks after their last dose (up to Day 56).	Placebo n=50 Participants During DB treatment phase, participants received placebo capsule (matching to JNJ-55308942), orally once daily from Day 1 (Week 0) up to 6 weeks. Participants were then followed up for up to 2 weeks after their last dose (up to Day 56).
Change From Baseline in MADRS Total Score up to Week 6 (Genetic Subgroup Analysis) P2RX7 GoF SNP mutation genotype: Homozygous	-18.2 Units on a scale Standard Deviation 13.06	-13.1 Units on a scale Standard Deviation 8.75
Change From Baseline in MADRS Total Score up to Week 6 (Genetic Subgroup Analysis) P2RX7 GoF SNP mutation genotype: Heterozygous	-15.2 Units on a scale Standard Deviation 9.45	-16.5 Units on a scale Standard Deviation 10.22

SECONDARY outcome

Timeframe: From Baseline (Day 1) up to Week 6

Change from baseline in MADRS total score up to Week 6 (Diagnosis Subgroup Analysis) were reported. Diagnosis subgroup analysis included participants with bipolar type 1 or II. MADRS was a clinician-rated scale designed to measure depression severity and detect changes due to AD treatment. The MADRS evaluated reported sadness, apparent sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. The scale consisted of 10 items, each of which was scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms),with higher score indicating a more severe condition. The MADRS total score was the sum of scores from individual question items and it ranged from 0 to 60, with higher scores indicated more severe conditions. Negative change in MADRS total score indicated improvement.

Outcome measures

Outcome measures
Measure	JNJ-55308942 n=42 Participants During double-blind (DB) treatment phase, participants received JNJ-55308942 capsule, orally once daily from Day 1 (Week 0) up to 6 weeks. Participants were then followed up for up to 2 weeks after their last dose (up to Day 56).	Placebo n=50 Participants During DB treatment phase, participants received placebo capsule (matching to JNJ-55308942), orally once daily from Day 1 (Week 0) up to 6 weeks. Participants were then followed up for up to 2 weeks after their last dose (up to Day 56).
Change From Baseline in MADRS Total Score up to Week 6 (Diagnosis Subgroup Analysis) Bipolar type II	-17.7 Units on a scale Standard Deviation 8.20	-15.7 Units on a scale Standard Deviation 9.47
Change From Baseline in MADRS Total Score up to Week 6 (Diagnosis Subgroup Analysis) Bipolar type I	-15.5 Units on a scale Standard Deviation 11.02	-15.3 Units on a scale Standard Deviation 10.06

SECONDARY outcome

Timeframe: From Baseline (Day 1) up to Week 6

Biomarker subgroup analysis included specific (3-Marker Model \[3MM\]) biomarker profile: Yes or No. 3MM biomarker profile was defined as serum C-reactive protein \>3 mg/Liter(L) and soluble interleukin-6 receptor \>25 micrograms(mcg)/L or tumor necrosis factor \>4 nanograms(ng)/L at baseline. MADRS was a clinician-rated scale designed to measure depression severity and detect changes due to AD treatment. MADRS evaluated reported sadness, apparent sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Scale consist of 10 items each of which was scored from 0(item not present or normal) to 6(severe or continuous presence of the symptoms),with higher score indicating a more severe condition. MADRS total score was sum of scores from individual question items, ranged from 0 to 60,with higher scores indicated more severe conditions. Negative change in MADRS total score indicated improvement.

Outcome measures

Outcome measures
Measure	JNJ-55308942 n=42 Participants During double-blind (DB) treatment phase, participants received JNJ-55308942 capsule, orally once daily from Day 1 (Week 0) up to 6 weeks. Participants were then followed up for up to 2 weeks after their last dose (up to Day 56).	Placebo n=49 Participants During DB treatment phase, participants received placebo capsule (matching to JNJ-55308942), orally once daily from Day 1 (Week 0) up to 6 weeks. Participants were then followed up for up to 2 weeks after their last dose (up to Day 56).
Change From Baseline in MADRS Total Score up to Week 6 (Biomarker Subgroup Analysis) 3MM biomarker profile: Yes	-12.5 Units on a scale Standard Deviation 9.04	-13.9 Units on a scale Standard Deviation 10.77
Change From Baseline in MADRS Total Score up to Week 6 (Biomarker Subgroup Analysis) 3MM biomarker profile: No	-17.2 Units on a scale Standard Deviation 10.75	-16.6 Units on a scale Standard Deviation 9.17

SECONDARY outcome

Timeframe: Weeks 1, 2, 4, 6, and 8 (Follow-up/Early Withdrawal)

Population: Safety analysis set included all randomized participants who took at least 1 dose of study intervention. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) is defined as participants analyzed at specified categories.

Vital signs parameters included pulse rate (abnormally low \[AL\]: \<50 beats per minute \[bpm\] and with \>15 bpm decrease from baseline and abnormally high \[AH\]: \>100 bpm and with \>15 bpm increase from baseline), Systolic blood pressure (SBP) (AL: \<90 millimeters of mercury \[mmHg\] and with \>20 mmHg decrease from baseline and AH: \>180 mmHg and with \>20 mmHg increase from baseline), Diastolic blood pressure (DBP) (AL: \<50 mmHg and with \>15 mmHg decrease from baseline and AH: \>105 mmHg and with \>15 mmHg increase from baseline) , temperature (AL:\<35.5 and AH:\>37.5 degree Celsius \[C\]), respiratory rate (AH :\>20 breaths per minute), and weight (AL: decrease from baseline \>7% and AH: increase from baseline \>7%). Weight was planned to analyzed at Weeks 6 and 8 only. Treatment-emergent concluded if postbaseline value was above/below upper/lower limit and baseline value was below/above the upper/lower limit.

Outcome measures

Outcome measures
Measure	JNJ-55308942 n=49 Participants During double-blind (DB) treatment phase, participants received JNJ-55308942 capsule, orally once daily from Day 1 (Week 0) up to 6 weeks. Participants were then followed up for up to 2 weeks after their last dose (up to Day 56).	Placebo n=56 Participants During DB treatment phase, participants received placebo capsule (matching to JNJ-55308942), orally once daily from Day 1 (Week 0) up to 6 weeks. Participants were then followed up for up to 2 weeks after their last dose (up to Day 56).
Number of Participants With Treatment-emergent Clinically Important Abnormalities in Vital Signs DBP (mmHg): >105 mmHg and with >15 mmHg increase from baseline: Week 1	0 Participants	0 Participants
Number of Participants With Treatment-emergent Clinically Important Abnormalities in Vital Signs DBP: <50 mmHg and with >15 mmHg decrease from baseline: Week 2	0 Participants	0 Participants
Number of Participants With Treatment-emergent Clinically Important Abnormalities in Vital Signs Pulse (beats per minutes [bpm]): <50 bpm and with >15 bpm decrease from baseline: Week 1	0 Participants Interval 9.04 to	0 Participants Interval 10.77 to
Number of Participants With Treatment-emergent Clinically Important Abnormalities in Vital Signs Pulse (bpm): >100 bpm and with >15 bpm increase from baseline: Week 1	0 Participants Interval 10.75 to	0 Participants Interval 9.17 to
Number of Participants With Treatment-emergent Clinically Important Abnormalities in Vital Signs SBP (millimeters of mercury [mmHg]): <90 mmHg and with >20 mmHg decrease from baseline: Week 1	0 Participants	0 Participants
Number of Participants With Treatment-emergent Clinically Important Abnormalities in Vital Signs SBP (mmHg): >180 mmHg and with >20 mmHg increase from baseline: Week 1	0 Participants	0 Participants
Number of Participants With Treatment-emergent Clinically Important Abnormalities in Vital Signs DBP (mmHg): <50 mmHg and with >15 mmHg decrease from baseline : Week 1	0 Participants	0 Participants
Number of Participants With Treatment-emergent Clinically Important Abnormalities in Vital Signs Temperature (degree Celsius [C]): <35.5 degree C: Week 1	0 Participants	0 Participants
Number of Participants With Treatment-emergent Clinically Important Abnormalities in Vital Signs Temperature (degree C): >37.5 degree C: Week 1	0 Participants	0 Participants
Number of Participants With Treatment-emergent Clinically Important Abnormalities in Vital Signs Respiratory Rate: >20 breaths per minute: Week 1	0 Participants	0 Participants
Number of Participants With Treatment-emergent Clinically Important Abnormalities in Vital Signs Pulse: <50 bpm and with >15 bpm decrease from baseline: Week 2	0 Participants	0 Participants
Number of Participants With Treatment-emergent Clinically Important Abnormalities in Vital Signs Pulse: >100 bpm and with >15 bpm increase from baseline: Week 2	0 Participants	0 Participants
Number of Participants With Treatment-emergent Clinically Important Abnormalities in Vital Signs SBP:<90 mmHg and with >20 mmHg decrease from baseline: Week 2	0 Participants	0 Participants
Number of Participants With Treatment-emergent Clinically Important Abnormalities in Vital Signs SBP: >180 mmHg and with >20 mmHg increase from baseline: Week 2	0 Participants	0 Participants
Number of Participants With Treatment-emergent Clinically Important Abnormalities in Vital Signs DBP: >105 mmHg and with >15 mmHg increase from baseline: Week 2	0 Participants	0 Participants
Number of Participants With Treatment-emergent Clinically Important Abnormalities in Vital Signs Temperature (degree C): <35.5 degree C: Week 2	0 Participants	0 Participants
Number of Participants With Treatment-emergent Clinically Important Abnormalities in Vital Signs Temperature (degree C): >37.5 degree C: Week 2	0 Participants	0 Participants
Number of Participants With Treatment-emergent Clinically Important Abnormalities in Vital Signs Respiratory Rate: >20 breaths per minute: Week 2	0 Participants	1 Participants
Number of Participants With Treatment-emergent Clinically Important Abnormalities in Vital Signs Pulse (bpm): <50 bpm and with >15 bpm decrease from baseline: Week 4	0 Participants	0 Participants
Number of Participants With Treatment-emergent Clinically Important Abnormalities in Vital Signs Pulse (bpm): >100 bpm and with >15 bpm increase from baseline: Week 4	0 Participants	0 Participants
Number of Participants With Treatment-emergent Clinically Important Abnormalities in Vital Signs SBP (mmHg): <90 mmHg and with >20 mmHg decrease from baseline: Week 4	0 Participants	0 Participants
Number of Participants With Treatment-emergent Clinically Important Abnormalities in Vital Signs SBP (mmHg): >180 mmHg and with >20 mmHg increase from baseline: Week 4	0 Participants	0 Participants
Number of Participants With Treatment-emergent Clinically Important Abnormalities in Vital Signs DBP (mmHg): <50 mmHg and with >15 mmHg decrease from baseline: Week 4	0 Participants	0 Participants
Number of Participants With Treatment-emergent Clinically Important Abnormalities in Vital Signs DBP (mmHg): <105 mmHg and with >15 mmHg increase from baseline: Week 4	0 Participants	0 Participants
Number of Participants With Treatment-emergent Clinically Important Abnormalities in Vital Signs Temperature (degree C): <35.5 degree C: Week 4	0 Participants	0 Participants
Number of Participants With Treatment-emergent Clinically Important Abnormalities in Vital Signs Temperature (degree C): >37.5 degree C: Week 4	0 Participants	0 Participants
Number of Participants With Treatment-emergent Clinically Important Abnormalities in Vital Signs Respiratory Rate: >20 breaths per minute: Week 4	0 Participants	0 Participants
Number of Participants With Treatment-emergent Clinically Important Abnormalities in Vital Signs Pulse: <50 bpm and with >15 bpm decrease from baseline: Week 6	0 Participants	0 Participants
Number of Participants With Treatment-emergent Clinically Important Abnormalities in Vital Signs Pulse: <100 bpm and with >15 bpm increase from baseline: Week 6	0 Participants	0 Participants
Number of Participants With Treatment-emergent Clinically Important Abnormalities in Vital Signs SBP (mmHg): <90 mmHg and with >20 mmHg decrease from baseline: Week 6	0 Participants	0 Participants
Number of Participants With Treatment-emergent Clinically Important Abnormalities in Vital Signs SBP (mmHg): >180 mmHg and with >20 mmHg increase from baseline: Week 6	0 Participants	0 Participants
Number of Participants With Treatment-emergent Clinically Important Abnormalities in Vital Signs DBP (mmHg): <50 mmHg and with >15 mmHg decrease from baseline: Week 6	0 Participants	0 Participants
Number of Participants With Treatment-emergent Clinically Important Abnormalities in Vital Signs DBP (mmHg): >105 mmHg and with >15 mmHg increase from baseline: Week 6	0 Participants	0 Participants
Number of Participants With Treatment-emergent Clinically Important Abnormalities in Vital Signs Temperature (C): <35.5 degree C: Week 6	0 Participants	0 Participants
Number of Participants With Treatment-emergent Clinically Important Abnormalities in Vital Signs Temperature (degree C): <37.5 degree C: Week 6	0 Participants	0 Participants
Number of Participants With Treatment-emergent Clinically Important Abnormalities in Vital Signs Respiratory Rate (breaths/min): >20 breaths per minute: Week 6	0 Participants	0 Participants
Number of Participants With Treatment-emergent Clinically Important Abnormalities in Vital Signs Weight (kg): Decrease from baseline >7%: Week 6	0 Participants	0 Participants
Number of Participants With Treatment-emergent Clinically Important Abnormalities in Vital Signs Weight (kg): Increase from baseline >7%: Week 6	0 Participants	1 Participants
Number of Participants With Treatment-emergent Clinically Important Abnormalities in Vital Signs Pulse: <50 bpm and with >15 bpm decrease from baseline: Follow-up (Week 8)	0 Participants	0 Participants
Number of Participants With Treatment-emergent Clinically Important Abnormalities in Vital Signs Pulse: >100 bpm and with >15 bpm increase from baseline: Follow-up (Week 8)	1 Participants	0 Participants
Number of Participants With Treatment-emergent Clinically Important Abnormalities in Vital Signs SBP (mmHg): <90mmHg and with >20 mmHg decrease from baseline: Follow-up (Week 8)	0 Participants	0 Participants
Number of Participants With Treatment-emergent Clinically Important Abnormalities in Vital Signs SBP (mmHg):>180mmHg and with >20 mmHg increase from baseline: Follow-up (Week 8)	0 Participants	1 Participants
Number of Participants With Treatment-emergent Clinically Important Abnormalities in Vital Signs DBP (mmHg): <50mmHg and with >15mmHg decrease from baseline: Follow-up (Week 8)	0 Participants	0 Participants
Number of Participants With Treatment-emergent Clinically Important Abnormalities in Vital Signs DBP (mmHg):>105mmHg and with >15mmHg increase from baseline: Follow-up (Week 8)	0 Participants	1 Participants
Number of Participants With Treatment-emergent Clinically Important Abnormalities in Vital Signs Temperature (C): <35.5 degree C: Follow-up (Week 8)	0 Participants	0 Participants
Number of Participants With Treatment-emergent Clinically Important Abnormalities in Vital Signs Temperature (C): >37.5 degree C: Follow-up (Week 8)	0 Participants	0 Participants
Number of Participants With Treatment-emergent Clinically Important Abnormalities in Vital Signs Respiratory Rate (breaths/min): >20 breaths per minute: Follow-up (Week 8)	0 Participants	0 Participants
Number of Participants With Treatment-emergent Clinically Important Abnormalities in Vital Signs Weight (kg): Decrease from baseline >7%: Follow-up (Week 8)	1 Participants	0 Participants
Number of Participants With Treatment-emergent Clinically Important Abnormalities in Vital Signs Weight (kg): Increase from baseline >7%: Follow-up (Week 8)	0 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 4, 6, and 8 (Follow-up/Early Withdrawal)

Change from baseline in clinical laboratory values in male hormone (Inhibin B) were reported.

Outcome measures

Outcome measures
Measure	JNJ-55308942 n=16 Participants During double-blind (DB) treatment phase, participants received JNJ-55308942 capsule, orally once daily from Day 1 (Week 0) up to 6 weeks. Participants were then followed up for up to 2 weeks after their last dose (up to Day 56).	Placebo n=25 Participants During DB treatment phase, participants received placebo capsule (matching to JNJ-55308942), orally once daily from Day 1 (Week 0) up to 6 weeks. Participants were then followed up for up to 2 weeks after their last dose (up to Day 56).
Change From Baseline in Clinical Laboratory Values in Male Hormone: Inhibin B Week 4	-5.9 nanograms per liter (ng/L) Standard Deviation 30.45	3.1 nanograms per liter (ng/L) Standard Deviation 22.15
Change From Baseline in Clinical Laboratory Values in Male Hormone: Inhibin B Week 6	-2.1 nanograms per liter (ng/L) Standard Deviation 30.02	-1.8 nanograms per liter (ng/L) Standard Deviation 31.09
Change From Baseline in Clinical Laboratory Values in Male Hormone: Inhibin B Week 8	-1.2 nanograms per liter (ng/L) Standard Deviation 28.25	7.3 nanograms per liter (ng/L) Standard Deviation 19.60

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 4, 6, and 8 (Follow-up/Early Withdrawal)

Change from baseline in clinical laboratory values in male hormone (luteinizing hormone) were reported.

Outcome measures

Outcome measures
Measure	JNJ-55308942 n=16 Participants During double-blind (DB) treatment phase, participants received JNJ-55308942 capsule, orally once daily from Day 1 (Week 0) up to 6 weeks. Participants were then followed up for up to 2 weeks after their last dose (up to Day 56).	Placebo n=27 Participants During DB treatment phase, participants received placebo capsule (matching to JNJ-55308942), orally once daily from Day 1 (Week 0) up to 6 weeks. Participants were then followed up for up to 2 weeks after their last dose (up to Day 56).
Change From Baseline in Clinical Laboratory Values in Male Hormone: Luteinizing Hormone Week 4	0.15 International units per liter (IU/L) Standard Deviation 1.814	0.29 International units per liter (IU/L) Standard Deviation 1.513
Change From Baseline in Clinical Laboratory Values in Male Hormone: Luteinizing Hormone Week 6	-0.11 International units per liter (IU/L) Standard Deviation 1.677	0.63 International units per liter (IU/L) Standard Deviation 2.719
Change From Baseline in Clinical Laboratory Values in Male Hormone: Luteinizing Hormone Week 8	-0.35 International units per liter (IU/L) Standard Deviation 1.638	0.84 International units per liter (IU/L) Standard Deviation 2.103

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 4, 6, and 8 (Follow-up/Early Withdrawal)

Change from baseline in clinical laboratory values in male hormone (prolactin) were reported.

Outcome measures

Outcome measures
Measure	JNJ-55308942 n=16 Participants During double-blind (DB) treatment phase, participants received JNJ-55308942 capsule, orally once daily from Day 1 (Week 0) up to 6 weeks. Participants were then followed up for up to 2 weeks after their last dose (up to Day 56).	Placebo n=27 Participants During DB treatment phase, participants received placebo capsule (matching to JNJ-55308942), orally once daily from Day 1 (Week 0) up to 6 weeks. Participants were then followed up for up to 2 weeks after their last dose (up to Day 56).
Change From Baseline in Clinical Laboratory Values in Male Hormone: Prolactin Week 4	0.347 micrograms per liter (mcg/L) Standard Deviation 2.4360	1.803 micrograms per liter (mcg/L) Standard Deviation 3.6211
Change From Baseline in Clinical Laboratory Values in Male Hormone: Prolactin Week 6	0.551 micrograms per liter (mcg/L) Standard Deviation 3.1575	1.465 micrograms per liter (mcg/L) Standard Deviation 5.3742
Change From Baseline in Clinical Laboratory Values in Male Hormone: Prolactin Week 8	-0.160 micrograms per liter (mcg/L) Standard Deviation 3.8622	1.748 micrograms per liter (mcg/L) Standard Deviation 3.9231

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 4, 6, and 8 (Follow-up/Early Withdrawal)

Change from baseline in clinical laboratory values in male hormones (sex hormone binding globulin, testosterone \[free\], testosterone \[high sensitivity\], and testosterone \[low sensitivity\]) were reported.

Outcome measures

Outcome measures
Measure	JNJ-55308942 n=16 Participants During double-blind (DB) treatment phase, participants received JNJ-55308942 capsule, orally once daily from Day 1 (Week 0) up to 6 weeks. Participants were then followed up for up to 2 weeks after their last dose (up to Day 56).	Placebo n=27 Participants During DB treatment phase, participants received placebo capsule (matching to JNJ-55308942), orally once daily from Day 1 (Week 0) up to 6 weeks. Participants were then followed up for up to 2 weeks after their last dose (up to Day 56).
Change From Baseline in Clinical Laboratory Values in Male Hormones: Sex Hormone Binding Globulin, Testosterone (Free), Testosterone (High Sensitivity), and Testosterone (Low Sensitivity) Sex Hormone Binding Globulin: Week 4	-1.976 nanomoles per liter (nmol/L) Standard Deviation 7.1297	-0.574 nanomoles per liter (nmol/L) Standard Deviation 8.5796
Change From Baseline in Clinical Laboratory Values in Male Hormones: Sex Hormone Binding Globulin, Testosterone (Free), Testosterone (High Sensitivity), and Testosterone (Low Sensitivity) Sex Hormone Binding Globulin: Week 6	-4.020 nanomoles per liter (nmol/L) Standard Deviation 7.4992	-0.274 nanomoles per liter (nmol/L) Standard Deviation 9.2454
Change From Baseline in Clinical Laboratory Values in Male Hormones: Sex Hormone Binding Globulin, Testosterone (Free), Testosterone (High Sensitivity), and Testosterone (Low Sensitivity) Sex Hormone Binding Globulin: Week 8	-2.520 nanomoles per liter (nmol/L) Standard Deviation 7.8489	1.058 nanomoles per liter (nmol/L) Standard Deviation 6.6109
Change From Baseline in Clinical Laboratory Values in Male Hormones: Sex Hormone Binding Globulin, Testosterone (Free), Testosterone (High Sensitivity), and Testosterone (Low Sensitivity) Testosterone, Free: Week 4	0.005 nanomoles per liter (nmol/L) Standard Deviation 0.0677	0.030 nanomoles per liter (nmol/L) Standard Deviation 0.0995
Change From Baseline in Clinical Laboratory Values in Male Hormones: Sex Hormone Binding Globulin, Testosterone (Free), Testosterone (High Sensitivity), and Testosterone (Low Sensitivity) Testosterone, Free: Week 6	-0.010 nanomoles per liter (nmol/L) Standard Deviation 0.0731	0.037 nanomoles per liter (nmol/L) Standard Deviation 0.1084
Change From Baseline in Clinical Laboratory Values in Male Hormones: Sex Hormone Binding Globulin, Testosterone (Free), Testosterone (High Sensitivity), and Testosterone (Low Sensitivity) Testosterone, Free: Week 8	0.031 nanomoles per liter (nmol/L) Standard Deviation 0.0763	0.046 nanomoles per liter (nmol/L) Standard Deviation 0.0877
Change From Baseline in Clinical Laboratory Values in Male Hormones: Sex Hormone Binding Globulin, Testosterone (Free), Testosterone (High Sensitivity), and Testosterone (Low Sensitivity) Testosterone, High Sensitivity: Week 4	-0.797 nanomoles per liter (nmol/L) Standard Deviation 3.3271	0.357 nanomoles per liter (nmol/L) Standard Deviation 5.5917
Change From Baseline in Clinical Laboratory Values in Male Hormones: Sex Hormone Binding Globulin, Testosterone (Free), Testosterone (High Sensitivity), and Testosterone (Low Sensitivity) Testosterone, High Sensitivity: Week 6	-1.262 nanomoles per liter (nmol/L) Standard Deviation 3.6807	0.842 nanomoles per liter (nmol/L) Standard Deviation 5.6815
Change From Baseline in Clinical Laboratory Values in Male Hormones: Sex Hormone Binding Globulin, Testosterone (Free), Testosterone (High Sensitivity), and Testosterone (Low Sensitivity) Testosterone, High Sensitivity: Week 8	0.604 nanomoles per liter (nmol/L) Standard Deviation 3.7718	1.416 nanomoles per liter (nmol/L) Standard Deviation 4.3083
Change From Baseline in Clinical Laboratory Values in Male Hormones: Sex Hormone Binding Globulin, Testosterone (Free), Testosterone (High Sensitivity), and Testosterone (Low Sensitivity) Testosterone, Low Sensitivity: Week 4	-0.791 nanomoles per liter (nmol/L) Standard Deviation 3.8886	0.854 nanomoles per liter (nmol/L) Standard Deviation 5.9616
Change From Baseline in Clinical Laboratory Values in Male Hormones: Sex Hormone Binding Globulin, Testosterone (Free), Testosterone (High Sensitivity), and Testosterone (Low Sensitivity) Testosterone, Low Sensitivity: Week 6	-1.532 nanomoles per liter (nmol/L) Standard Deviation 4.5203	1.380 nanomoles per liter (nmol/L) Standard Deviation 5.9515
Change From Baseline in Clinical Laboratory Values in Male Hormones: Sex Hormone Binding Globulin, Testosterone (Free), Testosterone (High Sensitivity), and Testosterone (Low Sensitivity) Testosterone, Low Sensitivity: Week 8	1.116 nanomoles per liter (nmol/L) Standard Deviation 4.8452	1.728 nanomoles per liter (nmol/L) Standard Deviation 4.6578

SECONDARY outcome

Timeframe: Weeks 2, 4, 6, and 8 (Follow-up/Early Withdrawal)

Population: Safety analysis set included all randomized participants who took at least 1 dose of study intervention. Here, 'n' (number analyzed) is defined as participants analyzed at specified categories.

Number of participants with abnormal laboratory values: serum chemistry were reported. It included: aspartate aminotransferase (high), alanine aminotransferase (high), bilirubin (high/low), and alkaline phosphatase (high/low). Only categories with data were reported.

Outcome measures

Outcome measures
Measure	JNJ-55308942 n=54 Participants During double-blind (DB) treatment phase, participants received JNJ-55308942 capsule, orally once daily from Day 1 (Week 0) up to 6 weeks. Participants were then followed up for up to 2 weeks after their last dose (up to Day 56).	Placebo n=60 Participants During DB treatment phase, participants received placebo capsule (matching to JNJ-55308942), orally once daily from Day 1 (Week 0) up to 6 weeks. Participants were then followed up for up to 2 weeks after their last dose (up to Day 56).
Number of Participants With Abnormal Laboratory Values: Serum Chemistry Aspartate Aminotransferase (High): Week 2	2 Participants	2 Participants
Number of Participants With Abnormal Laboratory Values: Serum Chemistry Aspartate Aminotransferase (High): Week 4	0 Participants	2 Participants
Number of Participants With Abnormal Laboratory Values: Serum Chemistry Aspartate Aminotransferase (High): Week 6	1 Participants	0 Participants
Number of Participants With Abnormal Laboratory Values: Serum Chemistry Aspartate Aminotransferase (High): Week 8	0 Participants	2 Participants
Number of Participants With Abnormal Laboratory Values: Serum Chemistry Alanine Aminotransferase (High): Week 2	1 Participants	3 Participants
Number of Participants With Abnormal Laboratory Values: Serum Chemistry Alanine Aminotransferase (High): Week 4	2 Participants	3 Participants
Number of Participants With Abnormal Laboratory Values: Serum Chemistry Alanine Aminotransferase (High): Week 6	2 Participants	1 Participants
Number of Participants With Abnormal Laboratory Values: Serum Chemistry Alanine Aminotransferase (High): Week 8	1 Participants	2 Participants
Number of Participants With Abnormal Laboratory Values: Serum Chemistry Bilirubin (Low): Week 2	4 Participants	9 Participants
Number of Participants With Abnormal Laboratory Values: Serum Chemistry Bilirubin (High): Week 2	1 Participants	0 Participants
Number of Participants With Abnormal Laboratory Values: Serum Chemistry Bilirubin (Low): Week 4	8 Participants	7 Participants
Number of Participants With Abnormal Laboratory Values: Serum Chemistry Bilirubin (Low): Week 6	5 Participants	4 Participants
Number of Participants With Abnormal Laboratory Values: Serum Chemistry Bilirubin (High): Week 6	2 Participants	0 Participants
Number of Participants With Abnormal Laboratory Values: Serum Chemistry Bilirubin (Low): Week 8	3 Participants	5 Participants
Number of Participants With Abnormal Laboratory Values: Serum Chemistry Bilirubin (High): Week 8	1 Participants	0 Participants
Number of Participants With Abnormal Laboratory Values: Serum Chemistry Alkaline Phosphatase (Low): Week 2	1 Participants	0 Participants
Number of Participants With Abnormal Laboratory Values: Serum Chemistry Alkaline Phosphatase (High): Week 2	3 Participants	5 Participants
Number of Participants With Abnormal Laboratory Values: Serum Chemistry Alkaline Phosphatase (Low): Week 4	1 Participants	0 Participants
Number of Participants With Abnormal Laboratory Values: Serum Chemistry Alkaline Phosphatase (High): Week 4	0 Participants	3 Participants
Number of Participants With Abnormal Laboratory Values: Serum Chemistry Alkaline Phosphatase (Low): Week 6	1 Participants	0 Participants
Number of Participants With Abnormal Laboratory Values: Serum Chemistry Alkaline Phosphatase (High): Week 6	1 Participants	6 Participants
Number of Participants With Abnormal Laboratory Values: Serum Chemistry Alkaline Phosphatase (Low): Week 8	1 Participants	0 Participants
Number of Participants With Abnormal Laboratory Values: Serum Chemistry Alkaline Phosphatase (High): Week 8	4 Participants	5 Participants

SECONDARY outcome

Timeframe: Weeks 2, 4, 6, and 8 (Follow-up/Early Withdrawal)

Population: Safety analysis set included all randomized participants who took at least 1 dose of study intervention.

Number of participants with clinically significant abnormal laboratory values: hematology were reported.

Outcome measures

Outcome measures
Measure	JNJ-55308942 n=54 Participants During double-blind (DB) treatment phase, participants received JNJ-55308942 capsule, orally once daily from Day 1 (Week 0) up to 6 weeks. Participants were then followed up for up to 2 weeks after their last dose (up to Day 56).	Placebo n=60 Participants During DB treatment phase, participants received placebo capsule (matching to JNJ-55308942), orally once daily from Day 1 (Week 0) up to 6 weeks. Participants were then followed up for up to 2 weeks after their last dose (up to Day 56).
Number of Participants With Clinically Significant Abnormal Laboratory Values: Hematology Week 2	0 Participants	0 Participants
Number of Participants With Clinically Significant Abnormal Laboratory Values: Hematology Week 4	0 Participants	0 Participants
Number of Participants With Clinically Significant Abnormal Laboratory Values: Hematology Week 6	0 Participants	0 Participants
Number of Participants With Clinically Significant Abnormal Laboratory Values: Hematology Week 8	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Weeks 2, 4, 6, and 8 (Follow-up/Early Withdrawal)

Population: Safety analysis set included all randomized participants who took at least 1 dose of study intervention.

Number of participants with clinically significant abnormal laboratory values: urinalysis were reported.

Outcome measures

Outcome measures
Measure	JNJ-55308942 n=54 Participants During double-blind (DB) treatment phase, participants received JNJ-55308942 capsule, orally once daily from Day 1 (Week 0) up to 6 weeks. Participants were then followed up for up to 2 weeks after their last dose (up to Day 56).	Placebo n=60 Participants During DB treatment phase, participants received placebo capsule (matching to JNJ-55308942), orally once daily from Day 1 (Week 0) up to 6 weeks. Participants were then followed up for up to 2 weeks after their last dose (up to Day 56).
Number of Participants With Clinically Significant Abnormal Laboratory Values: Urinalysis Week 2	0 Participants	0 Participants
Number of Participants With Clinically Significant Abnormal Laboratory Values: Urinalysis Week 4	0 Participants	0 Participants
Number of Participants With Clinically Significant Abnormal Laboratory Values: Urinalysis Week 6	0 Participants	0 Participants
Number of Participants With Clinically Significant Abnormal Laboratory Values: Urinalysis Week 8	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 1 (Week 0) up to 30 days after the last dose (up to 11 weeks)

Population: Safety analysis set included all randomized participants who took at least 1 dose of study intervention.

Number of participants with TEAEs were reported. An adverse event (AE) is any untoward medical occurrence in a clinical study participants who administered a medicinal (investigational or non-investigational) product and does not necessarily have a causal relationship with the treatment. A TEAE defined as an AE that occurred at or after the first dose administration up to day of the last dose plus 30 days.

Outcome measures

Outcome measures
Measure	JNJ-55308942 n=54 Participants During double-blind (DB) treatment phase, participants received JNJ-55308942 capsule, orally once daily from Day 1 (Week 0) up to 6 weeks. Participants were then followed up for up to 2 weeks after their last dose (up to Day 56).	Placebo n=60 Participants During DB treatment phase, participants received placebo capsule (matching to JNJ-55308942), orally once daily from Day 1 (Week 0) up to 6 weeks. Participants were then followed up for up to 2 weeks after their last dose (up to Day 56).
Number of Participants With Treatment-emergent Adverse Events (TEAEs)	22 Participants	28 Participants

SECONDARY outcome

Timeframe: Weeks 1, 2, 4, 6, and 8 (Follow-up/Early Withdrawal)

Number of participants with treatment-emergent abnormalities in ECGs were reported. It included ECG mean heart rate (abnormally low \[AL\]: \<50 and abnormally high \[AH\]: \>100 beats per minute \[bpm\]), PR Interval (AL: \<120 and AH: \>200 milliseconds \[msec\]), QRS Duration (AL: \<60 and AH: \>120 msec), and QT Interval (AL: \<200 and AH: \>500 msec). A treatment-emergent abnormalities in ECGs are defined as those abnormalities that occurred at or after the first dose administration.

Outcome measures

Outcome measures
Measure	JNJ-55308942 n=54 Participants During double-blind (DB) treatment phase, participants received JNJ-55308942 capsule, orally once daily from Day 1 (Week 0) up to 6 weeks. Participants were then followed up for up to 2 weeks after their last dose (up to Day 56).	Placebo n=60 Participants During DB treatment phase, participants received placebo capsule (matching to JNJ-55308942), orally once daily from Day 1 (Week 0) up to 6 weeks. Participants were then followed up for up to 2 weeks after their last dose (up to Day 56).
Number of Participants With Treatment-emergent Abnormalities in Electrocardiograms (ECGs) ECG Mean Heart Rate: <50 bpm: Week 1	1 Participants	0 Participants
Number of Participants With Treatment-emergent Abnormalities in Electrocardiograms (ECGs) ECG Mean Heart Rate: >100 bpm: Week 1	0 Participants	0 Participants
Number of Participants With Treatment-emergent Abnormalities in Electrocardiograms (ECGs) PR Interval: <120 msec: Week 1	0 Participants	1 Participants
Number of Participants With Treatment-emergent Abnormalities in Electrocardiograms (ECGs) PR Interval: >200 msec: Week 1	1 Participants	0 Participants
Number of Participants With Treatment-emergent Abnormalities in Electrocardiograms (ECGs) QRS Duration: <60 msec: Week 1	0 Participants	1 Participants
Number of Participants With Treatment-emergent Abnormalities in Electrocardiograms (ECGs) QRS Duration: >120 msec: Week 1	1 Participants	0 Participants
Number of Participants With Treatment-emergent Abnormalities in Electrocardiograms (ECGs) QT Interval: <200 msec: Week 1	0 Participants	0 Participants
Number of Participants With Treatment-emergent Abnormalities in Electrocardiograms (ECGs) QT Interval: >500 msec: Week 1	0 Participants	0 Participants
Number of Participants With Treatment-emergent Abnormalities in Electrocardiograms (ECGs) ECG Mean Heart Rate: <50 bpm: Week 2	0 Participants	0 Participants
Number of Participants With Treatment-emergent Abnormalities in Electrocardiograms (ECGs) ECG Mean Heart Rate: >100 bpm: Week 2	1 Participants	1 Participants
Number of Participants With Treatment-emergent Abnormalities in Electrocardiograms (ECGs) PR Interval: <120 msec: Week 2	0 Participants	0 Participants
Number of Participants With Treatment-emergent Abnormalities in Electrocardiograms (ECGs) PR Interval: >200 msec: Week 2	1 Participants	2 Participants
Number of Participants With Treatment-emergent Abnormalities in Electrocardiograms (ECGs) QRS Duration: <60 msec: Week 2	0 Participants	1 Participants
Number of Participants With Treatment-emergent Abnormalities in Electrocardiograms (ECGs) QRS Duration: >120 msec: Week 2	0 Participants	1 Participants
Number of Participants With Treatment-emergent Abnormalities in Electrocardiograms (ECGs) QT Interval: <200 msec: Week 2	0 Participants	0 Participants
Number of Participants With Treatment-emergent Abnormalities in Electrocardiograms (ECGs) QT Interval: >500 msec: Week 2	0 Participants	0 Participants
Number of Participants With Treatment-emergent Abnormalities in Electrocardiograms (ECGs) ECG Mean Heart Rate: <50 bpm: Week 4	0 Participants	0 Participants
Number of Participants With Treatment-emergent Abnormalities in Electrocardiograms (ECGs) ECG Mean Heart Rate: >100 bpm: Week 4	1 Participants	0 Participants
Number of Participants With Treatment-emergent Abnormalities in Electrocardiograms (ECGs) PR Interval: <120 msec: Week 4	0 Participants	1 Participants
Number of Participants With Treatment-emergent Abnormalities in Electrocardiograms (ECGs) PR Interval: >200 msec: Week 4	0 Participants	0 Participants
Number of Participants With Treatment-emergent Abnormalities in Electrocardiograms (ECGs) QRS Duration: <60 msec: Week 4	0 Participants	1 Participants
Number of Participants With Treatment-emergent Abnormalities in Electrocardiograms (ECGs) QRS Duration: >120 msec: Week 4	1 Participants	0 Participants
Number of Participants With Treatment-emergent Abnormalities in Electrocardiograms (ECGs) QT Interval: <200 msec: Week 4	0 Participants	0 Participants
Number of Participants With Treatment-emergent Abnormalities in Electrocardiograms (ECGs) QT Interval: >500 msec: Week 4	0 Participants	0 Participants
Number of Participants With Treatment-emergent Abnormalities in Electrocardiograms (ECGs) ECG Mean Heart Rate: <50 bpm: Week 6	0 Participants	0 Participants
Number of Participants With Treatment-emergent Abnormalities in Electrocardiograms (ECGs) ECG Mean Heart Rate: >100 bpm: Week 6	0 Participants	0 Participants
Number of Participants With Treatment-emergent Abnormalities in Electrocardiograms (ECGs) PR Interval: <120 msec: Week 6	0 Participants	0 Participants
Number of Participants With Treatment-emergent Abnormalities in Electrocardiograms (ECGs) PR Interval: >200 msec: Week 6	0 Participants	0 Participants
Number of Participants With Treatment-emergent Abnormalities in Electrocardiograms (ECGs) QRS Duration: <60 msec: Week 6	0 Participants	4 Participants
Number of Participants With Treatment-emergent Abnormalities in Electrocardiograms (ECGs) QRS Duration: >120 msec: Week 6	0 Participants	0 Participants
Number of Participants With Treatment-emergent Abnormalities in Electrocardiograms (ECGs) QT Interval: <200 msec: Week 6	0 Participants	0 Participants
Number of Participants With Treatment-emergent Abnormalities in Electrocardiograms (ECGs) QT Interval: >500 msec: Week 6	0 Participants	0 Participants
Number of Participants With Treatment-emergent Abnormalities in Electrocardiograms (ECGs) ECG Mean Heart Rate: <50 bpm: Week 8	0 Participants	0 Participants
Number of Participants With Treatment-emergent Abnormalities in Electrocardiograms (ECGs) ECG Mean Heart Rate: >100 bpm: Week 8	0 Participants	0 Participants
Number of Participants With Treatment-emergent Abnormalities in Electrocardiograms (ECGs) PR Interval: <120 msec: Week 8	1 Participants	0 Participants
Number of Participants With Treatment-emergent Abnormalities in Electrocardiograms (ECGs) PR Interval: >200 msec: Week 8	0 Participants	0 Participants
Number of Participants With Treatment-emergent Abnormalities in Electrocardiograms (ECGs) QRS Duration: <60 msec: Week 8	1 Participants	2 Participants
Number of Participants With Treatment-emergent Abnormalities in Electrocardiograms (ECGs) QRS Duration: >120 msec: Week 8	0 Participants	1 Participants
Number of Participants With Treatment-emergent Abnormalities in Electrocardiograms (ECGs) QT Interval: <200 msec: Week 8	0 Participants	0 Participants
Number of Participants With Treatment-emergent Abnormalities in Electrocardiograms (ECGs) QT Interval: >500 msec: Week 8	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From Baseline (Day 1) up to Week 6

Change from baseline in YMRS total score were reported. The YMRS was designed to measure the severity of manic symptoms, to gauge the effect of treatment on mania severity, and to detect a return of manic symptoms (for example relapse or recurrence). YMRS had 11 items : 4 items (irritability, speech, thought content, and disruptive/aggressive behavior) were graded on a scale of 0 to 8 and the remaining 7 items (elevated mood, increased motor activity, sexual interest, sleep, language-thought disorder, appearance, and insight) were graded on a scale of 0 to 4. Higher scores indicated greater symptom severity. Responses were summed to yield YMRS total score ranged from 0 to 60 , with higher scores reflecting greater severity of mania.

Outcome measures

Outcome measures
Measure	JNJ-55308942 n=42 Participants During double-blind (DB) treatment phase, participants received JNJ-55308942 capsule, orally once daily from Day 1 (Week 0) up to 6 weeks. Participants were then followed up for up to 2 weeks after their last dose (up to Day 56).	Placebo n=50 Participants During DB treatment phase, participants received placebo capsule (matching to JNJ-55308942), orally once daily from Day 1 (Week 0) up to 6 weeks. Participants were then followed up for up to 2 weeks after their last dose (up to Day 56).
Change From Baseline in Young Mania Rating Scale (YMRS) Total Score	-1.2 Units on a scale Standard Deviation 2.23	-1.1 Units on a scale Standard Deviation 1.81

SECONDARY outcome

Timeframe: From Baseline (Day 1) up to Week 8

C-SSRS is a clinician-rated instrument that reports severity of both suicidal ideation (SI) and suicidal behavior (SB). SI categories: 1 (wish to be dead), 2 (nonspecific active suicidal thoughts), 3 (active suicidal ideation with any methods \[not plan\] without intent to act), 4 (active SI with some intent to act, without specific plan), and 5 (active SI with specific plan and intent). SB categories: 6 (preparatory acts or behavior), 7 (aborted attempt), 8 (interrupted attempt), 9 (actual attempt), and 10 (suicide). An additional category for non-suicide: non-suicidal self-injurious behavior. SI/SB was indicated by a "yes" answer to any of the listed categories. Score of 0 (no SI or SB) was assigned. Maximum score of 1 to 10 was assigned if suicidal ideation or behavior was present. Scoring was grouped into 3 categories: No SI/SB (0), SI (score 1 to 5), and SB (score 6 to 10), with higher scores indicating more severe ideation/behavior.

Outcome measures

Outcome measures
Measure	JNJ-55308942 n=53 Participants During double-blind (DB) treatment phase, participants received JNJ-55308942 capsule, orally once daily from Day 1 (Week 0) up to 6 weeks. Participants were then followed up for up to 2 weeks after their last dose (up to Day 56).	Placebo n=59 Participants During DB treatment phase, participants received placebo capsule (matching to JNJ-55308942), orally once daily from Day 1 (Week 0) up to 6 weeks. Participants were then followed up for up to 2 weeks after their last dose (up to Day 56).
Number of Participants Who Reported Suicidal Ideation (SI) or Suicidal Behavior (SB) Using With Columbia Suicide Severity Rating Scale (C-SSRS) Score Suicidal ideation	3 Participants	6 Participants
Number of Participants Who Reported Suicidal Ideation (SI) or Suicidal Behavior (SB) Using With Columbia Suicide Severity Rating Scale (C-SSRS) Score Suicidal behavior	1 Participants	0 Participants
Number of Participants Who Reported Suicidal Ideation (SI) or Suicidal Behavior (SB) Using With Columbia Suicide Severity Rating Scale (C-SSRS) Score No SI/SB	49 Participants Interval 2.23 to	53 Participants Interval 1.81 to

SECONDARY outcome

Timeframe: From Baseline (Day 1) up to Week 6

Change from baseline in CGI-S score were reported. The CGI-S provides an overall clinician-determined summary measure of the severity of the participant's illness that takes into account all available information, including knowledge of the participant's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the participant's ability to function. The CGI-S is a 7-point global assessment scale that measures the clinician's impression of the severity of mental illness exhibited by a participant, and rated on a scale of 1 to 7: 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; and 7=among the most extremely ill participants. Higher scores indicate worsening. Negative change in CGI-S score indicate improvement.

Outcome measures

Outcome measures
Measure	JNJ-55308942 n=42 Participants During double-blind (DB) treatment phase, participants received JNJ-55308942 capsule, orally once daily from Day 1 (Week 0) up to 6 weeks. Participants were then followed up for up to 2 weeks after their last dose (up to Day 56).	Placebo n=50 Participants During DB treatment phase, participants received placebo capsule (matching to JNJ-55308942), orally once daily from Day 1 (Week 0) up to 6 weeks. Participants were then followed up for up to 2 weeks after their last dose (up to Day 56).
Change From Baseline in Clinical Global Impression-Severity Scale (CGI-S) Score	-1.9 Units on a scale Standard Deviation 1.49	-1.7 Units on a scale Standard Deviation 1.32

SECONDARY outcome

Timeframe: Predose, 1.5 hours and 4 hours post-dose on Week 0 (Day 1), Weeks 1 (Day 8), 2 (Day 15), 4 (Day 29), and 6 (Day 43)

Population: Pharmacokinetics (PK) analysis set included all participants who received at least 1 dose of JNJ-55308942 and had at least 1 valid blood sample drawn for PK analysis. Here, 'n' (number analyzed) is defined as participants analyzed at specified categories. Data for this outcome measure was not planned to be collected and analyzed for placebo arm.

Plasma concentrations of JNJ-55308942 were reported.

Outcome measures

Outcome measures
Measure	JNJ-55308942 n=53 Participants During double-blind (DB) treatment phase, participants received JNJ-55308942 capsule, orally once daily from Day 1 (Week 0) up to 6 weeks. Participants were then followed up for up to 2 weeks after their last dose (up to Day 56).	Placebo During DB treatment phase, participants received placebo capsule (matching to JNJ-55308942), orally once daily from Day 1 (Week 0) up to 6 weeks. Participants were then followed up for up to 2 weeks after their last dose (up to Day 56).
Plasma Concentrations of JNJ-55308942 Week 6 (Day 43): 4 hours postdose	883.51 Nanograms per milliliter (ng/mL) Standard Deviation 209.413	—
Plasma Concentrations of JNJ-55308942 Week 0 (Day 1): Predose	0.00 Nanograms per milliliter (ng/mL) Standard Deviation 0.000	—
Plasma Concentrations of JNJ-55308942 Week 0 (Day 1): 1.5 hours postdose	406.13 Nanograms per milliliter (ng/mL) Standard Deviation 162.407	—
Plasma Concentrations of JNJ-55308942 Week 0 (Day 1): 4 hours postdose	407.72 Nanograms per milliliter (ng/mL) Standard Deviation 133.461	—
Plasma Concentrations of JNJ-55308942 Week 1 (Day 8): Predose	531.20 Nanograms per milliliter (ng/mL) Standard Deviation 200.351	—
Plasma Concentrations of JNJ-55308942 Week 1 (Day 8): 1.5 hours postdose	868.01 Nanograms per milliliter (ng/mL) Standard Deviation 296.255	—
Plasma Concentrations of JNJ-55308942 Week 1 (Day 8): 4 hours postdose	892.54 Nanograms per milliliter (ng/mL) Standard Deviation 219.210	—
Plasma Concentrations of JNJ-55308942 Week 2 (Day 15): Predose	561.32 Nanograms per milliliter (ng/mL) Standard Deviation 194.184	—
Plasma Concentrations of JNJ-55308942 Week 2 (Day 15): 1.5 hours postdose	930.59 Nanograms per milliliter (ng/mL) Standard Deviation 265.581	—
Plasma Concentrations of JNJ-55308942 Week 2 (Day 15): 4 hours postdose	919.86 Nanograms per milliliter (ng/mL) Standard Deviation 213.028	—
Plasma Concentrations of JNJ-55308942 Week 4 (Day 29): Predose	528.90 Nanograms per milliliter (ng/mL) Standard Deviation 144.580	—
Plasma Concentrations of JNJ-55308942 Week 4 (Day 29): 1.5 hours postdose	885.50 Nanograms per milliliter (ng/mL) Standard Deviation 249.562	—
Plasma Concentrations of JNJ-55308942 Week 4 (Day 29): 4 hours postdose	872.80 Nanograms per milliliter (ng/mL) Standard Deviation 208.734	—
Plasma Concentrations of JNJ-55308942 Week 6 (Day 43): Predose	535.80 Nanograms per milliliter (ng/mL) Standard Deviation 160.568	—
Plasma Concentrations of JNJ-55308942 Week 6 (Day 43): 1.5 hours postdose	862.31 Nanograms per milliliter (ng/mL) Standard Deviation 240.540	—

SECONDARY outcome

Timeframe: Baseline (Day 1), Weeks 1, 2, 3, 4, 5, and 6

Change from baseline in PROMIS score - ability to participate in social roles and activities T-Scores were reported. The PROMIS - APS item bank assessed the perceived ability to perform one's usual social roles and activities. The item bank did not use a time frame (for example, over the past seven days) when assessing the APS. The Short Form 4a included 4 items that represent this concept. Each question had 5 response options ranging in value from 1 to 5 with higher scores indicating better social function. The total raw score for the short form was calculated by summing the values of the response to each question, so for the 4-item form, the lowest possible raw score was 4; the highest possible raw score was 20. The total raw score was converted to a T score with a mean of 50 and a standard deviation of 10. Higher T-scores indicate better social function.

Outcome measures

Outcome measures
Measure	JNJ-55308942 n=48 Participants During double-blind (DB) treatment phase, participants received JNJ-55308942 capsule, orally once daily from Day 1 (Week 0) up to 6 weeks. Participants were then followed up for up to 2 weeks after their last dose (up to Day 56).	Placebo n=59 Participants During DB treatment phase, participants received placebo capsule (matching to JNJ-55308942), orally once daily from Day 1 (Week 0) up to 6 weeks. Participants were then followed up for up to 2 weeks after their last dose (up to Day 56).
Change From Baseline in Patient Reported Outcomes Measurement Information System (PROMIS) Score - Ability to Participate in Social Roles and Activities (APS) T-Scores PROMIS-APS T-score: Week 1	2.51 T-score Standard Deviation 5.682	1.69 T-score Standard Deviation 6.859
Change From Baseline in Patient Reported Outcomes Measurement Information System (PROMIS) Score - Ability to Participate in Social Roles and Activities (APS) T-Scores PROMIS-APS T-score: Week 2	5.33 T-score Standard Deviation 6.901	4.49 T-score Standard Deviation 9.174
Change From Baseline in Patient Reported Outcomes Measurement Information System (PROMIS) Score - Ability to Participate in Social Roles and Activities (APS) T-Scores PROMIS-APS T-score: Week 3	6.52 T-score Standard Deviation 8.226	5.00 T-score Standard Deviation 8.884
Change From Baseline in Patient Reported Outcomes Measurement Information System (PROMIS) Score - Ability to Participate in Social Roles and Activities (APS) T-Scores PROMIS-APS T-score: Week 4	9.12 T-score Standard Deviation 9.018	6.07 T-score Standard Deviation 8.369
Change From Baseline in Patient Reported Outcomes Measurement Information System (PROMIS) Score - Ability to Participate in Social Roles and Activities (APS) T-Scores PROMIS-APS T-score: Week 5	9.47 T-score Standard Deviation 8.248	4.90 T-score Standard Deviation 9.296
Change From Baseline in Patient Reported Outcomes Measurement Information System (PROMIS) Score - Ability to Participate in Social Roles and Activities (APS) T-Scores PROMIS-APS T-score: Week 6	10.50 T-score Standard Deviation 8.211	6.12 T-score Standard Deviation 8.412

SECONDARY outcome

Timeframe: Baseline (Day 1), Weeks 1, 2, 3, 4, 5, and 6

Change from baseline in PHQ-9 total score were reported. PHQ-9 is 9-item, self-report scale assessed depressive symptoms. Each item was rated on 4-point scale (0=Not at all, 1=several days, 2=more than half days, 3=nearly every day. The participant's item responses were summed to provide PHQ-9 total score (range of 0 to 27) with higher scores indicating greater severity of depressive symptoms.

Outcome measures

Outcome measures
Measure	JNJ-55308942 n=48 Participants During double-blind (DB) treatment phase, participants received JNJ-55308942 capsule, orally once daily from Day 1 (Week 0) up to 6 weeks. Participants were then followed up for up to 2 weeks after their last dose (up to Day 56).	Placebo n=59 Participants During DB treatment phase, participants received placebo capsule (matching to JNJ-55308942), orally once daily from Day 1 (Week 0) up to 6 weeks. Participants were then followed up for up to 2 weeks after their last dose (up to Day 56).
Change From Baseline in Patient Health Questionnaire-9 (PHQ-9) Total Score Week 1	-2.8 Units on a scale Standard Deviation 4.24	-3.1 Units on a scale Standard Deviation 5.45
Change From Baseline in Patient Health Questionnaire-9 (PHQ-9) Total Score Week 2	-5.2 Units on a scale Standard Deviation 5.64	-4.7 Units on a scale Standard Deviation 6.63
Change From Baseline in Patient Health Questionnaire-9 (PHQ-9) Total Score Week 3	-6.4 Units on a scale Standard Deviation 6.25	-5.1 Units on a scale Standard Deviation 6.90
Change From Baseline in Patient Health Questionnaire-9 (PHQ-9) Total Score Week 4	-7.0 Units on a scale Standard Deviation 6.38	-6.1 Units on a scale Standard Deviation 6.81
Change From Baseline in Patient Health Questionnaire-9 (PHQ-9) Total Score Week 5	-8.2 Units on a scale Standard Deviation 6.59	-5.2 Units on a scale Standard Deviation 7.21
Change From Baseline in Patient Health Questionnaire-9 (PHQ-9) Total Score Week 6	-9.0 Units on a scale Standard Deviation 6.79	-7.0 Units on a scale Standard Deviation 7.41

SECONDARY outcome

Timeframe: Baseline (Day 1), Weeks 2, 4, and 6

Change from baseline in GAD-7 total score were reported. GAD-7 is a brief and validated 7-item self-reported questionnaire for assessment of overall GAD. Participants responded to each item using a 4-point scale with response categories of 0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day, with a higher score representing a more severe condition. Item responses were summed to yield GAD-7 total score which ranged of 0 to 21, where higher scores indicated more anxiety.

Outcome measures

Outcome measures
Measure	JNJ-55308942 n=48 Participants During double-blind (DB) treatment phase, participants received JNJ-55308942 capsule, orally once daily from Day 1 (Week 0) up to 6 weeks. Participants were then followed up for up to 2 weeks after their last dose (up to Day 56).	Placebo n=59 Participants During DB treatment phase, participants received placebo capsule (matching to JNJ-55308942), orally once daily from Day 1 (Week 0) up to 6 weeks. Participants were then followed up for up to 2 weeks after their last dose (up to Day 56).
Change From Baseline in Generalized Anxiety Disorder 7 (GAD-7) Total Score Week 2	-3.8 Units on a scale Standard Deviation 5.08	-4.2 Units on a scale Standard Deviation 5.76
Change From Baseline in Generalized Anxiety Disorder 7 (GAD-7) Total Score Week 4	-5.0 Units on a scale Standard Deviation 6.59	-4.5 Units on a scale Standard Deviation 5.14
Change From Baseline in Generalized Anxiety Disorder 7 (GAD-7) Total Score Week 6	-5.7 Units on a scale Standard Deviation 6.21	-5.7 Units on a scale Standard Deviation 5.77

SECONDARY outcome

Timeframe: Week 6

Population: FAS included all randomized participants who received at least 1 dose of study intervention and have both the baseline and at least 1 postbaseline MADRS measurement.

Number of participants who achieved response at Week 6 were reported. Response was defined as greater than or equal to (\>=)50% improvement in MADRS total score from baseline. MADRS was a clinician-rated scale designed to measure depression severity and detect changes due to AD treatment. The MADRS evaluated reported sadness, apparent sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. The scale consisted of 10 items, each of which was scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms),with higher score indicating a more severe condition. The MADRS total score was the sum of scores from individual question items and it ranged from 0 to 60, with higher scores indicated more severe conditions. Negative change in MADRS total score indicated improvement.

Outcome measures

Outcome measures
Measure	JNJ-55308942 n=48 Participants During double-blind (DB) treatment phase, participants received JNJ-55308942 capsule, orally once daily from Day 1 (Week 0) up to 6 weeks. Participants were then followed up for up to 2 weeks after their last dose (up to Day 56).	Placebo n=59 Participants During DB treatment phase, participants received placebo capsule (matching to JNJ-55308942), orally once daily from Day 1 (Week 0) up to 6 weeks. Participants were then followed up for up to 2 weeks after their last dose (up to Day 56).
Number of Participants Who Achieved Response at Week 6	27 Participants Interval 6.21 to	31 Participants Interval 5.77 to

SECONDARY outcome

Timeframe: Week 6

Population: FAS included all randomized participants who received at least 1 dose of study intervention and have both the baseline and at least 1 postbaseline MADRS measurement.

Number of participants who achieved remission at Week 6 were reported. Remission was defined as MADRS total score \<=12. MADRS was a clinician-rated scale designed to measure depression severity and detect changes due to AD treatment. The MADRS evaluated reported sadness, apparent sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. The scale consisted of 10 items, each of which was scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms),with higher score indicating a more severe condition. The MADRS total score was the sum of scores from individual question items and it ranged from 0 to 60, with higher scores indicated more severe conditions. Negative change in MADRS total score indicated improvement.

Outcome measures

Outcome measures
Measure	JNJ-55308942 n=48 Participants During double-blind (DB) treatment phase, participants received JNJ-55308942 capsule, orally once daily from Day 1 (Week 0) up to 6 weeks. Participants were then followed up for up to 2 weeks after their last dose (up to Day 56).	Placebo n=59 Participants During DB treatment phase, participants received placebo capsule (matching to JNJ-55308942), orally once daily from Day 1 (Week 0) up to 6 weeks. Participants were then followed up for up to 2 weeks after their last dose (up to Day 56).
Number of Participants Who Achieved Remission at Week 6	25 Participants Interval 6.21 to	30 Participants Interval 5.77 to

SECONDARY outcome

Timeframe: From Baseline (Day 1) up to Week 6

Population: FAS included all randomized participants who had received at least 1 dose of study intervention and have both the baseline and at least 1 postbaseline MADRS measurement.

Change from baseline in MADRS total score up to Week 6 (subgroup of participants with mRNA transcript levels) was planned to be reported. Subgroup included participants with mRNA transcript levels at baseline that exceeded the medium level for both P2RX7 and IL-1-beta. MADRS was a clinician-rated scale designed to measure depression severity and detect changes due to AD treatment. MADRS evaluated reported sadness, apparent sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. The scale consisted of 10 items, each of which was scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms),with higher score indicating a more severe condition. MADRS total score was the sum of scores from individual question items and it ranged from 0 to 60, with higher scores indicated more severe conditions. Negative change in MADRS total score indicated improvement.

Outcome measures

Outcome measures
Measure	JNJ-55308942 n=48 Participants During double-blind (DB) treatment phase, participants received JNJ-55308942 capsule, orally once daily from Day 1 (Week 0) up to 6 weeks. Participants were then followed up for up to 2 weeks after their last dose (up to Day 56).	Placebo n=59 Participants During DB treatment phase, participants received placebo capsule (matching to JNJ-55308942), orally once daily from Day 1 (Week 0) up to 6 weeks. Participants were then followed up for up to 2 weeks after their last dose (up to Day 56).
Change From Baseline in MADRS Total Score up to Week 6 (Subgroup of Participants With Messenger Ribonucleic Acid [mRNA] Transcript Levels)	NA Units on a scale Standard Deviation NA NA refers that mean and standard deviation were not calculable under acceptable margins for categorization of participants because of poor reproducibility of the PCR method using small RNA volumes, participants could not be categorized by mRNA transcript levels.	NA Units on a scale Standard Deviation NA NA refers that mean and standard deviation were not calculable under acceptable margins for categorization of participants because of poor reproducibility of the PCR method using small RNA volumes, participants could not be categorized by mRNA transcript levels.

SECONDARY outcome

Timeframe: From Baseline (Day 1) up to Week 6

Population: FAS included all randomized participants who had received at least 1 dose of study intervention and have both the baseline and at least 1 postbaseline MADRS measurement. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) is defined as participants analyzed at specified categories. n=0 signifies no participant was available for the analysis.

Change from baseline in MADRS total score up to Week 6 (concomitant medication subgroup analysis) was reported. Concomitant medication subgroup analysis included subjects with BD not taking any mood stabilizer or antipsychotic, taking a mood stabilizer alone, taking antipsychotic alone, and taking a combination of mood stabilizer and an antipsychotic. MADRS measures depression severity, detects changes due to AD treatment. It consists of 10 items (evaluate apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thoughts), scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), summed to total possible score of 0 to 60. Higher scores indicate more severe conditions. Negative change in score indicates improvement.

Outcome measures

Outcome measures
Measure	JNJ-55308942 n=42 Participants During double-blind (DB) treatment phase, participants received JNJ-55308942 capsule, orally once daily from Day 1 (Week 0) up to 6 weeks. Participants were then followed up for up to 2 weeks after their last dose (up to Day 56).	Placebo n=50 Participants During DB treatment phase, participants received placebo capsule (matching to JNJ-55308942), orally once daily from Day 1 (Week 0) up to 6 weeks. Participants were then followed up for up to 2 weeks after their last dose (up to Day 56).
Change From Baseline in MADRS Total Score up to Week 6 (Concomitant Medication Subgroup Analysis) Concomitant medication status: Not taking any mood stabilizer or antipsychotic	-15.5 Units on a scale Standard Deviation 13.18	-16.2 Units on a scale Standard Deviation 9.69
Change From Baseline in MADRS Total Score up to Week 6 (Concomitant Medication Subgroup Analysis) Concomitant medication status: Taking a mood stabilizer alone	-16.3 Units on a scale Standard Deviation 9.82	-15.6 Units on a scale Standard Deviation 9.47
Change From Baseline in MADRS Total Score up to Week 6 (Concomitant Medication Subgroup Analysis) Concomitant medication status: Taking an antipsychotic alone	-13.0 Units on a scale Standard Deviation NA NA refers to standard deviation was not estimable as only 1 participant was analyzed.	5.0 Units on a scale Standard Deviation NA NA refers to standard deviation was not estimable as only 1 participant was analyzed.
Change From Baseline in MADRS Total Score up to Week 6 (Concomitant Medication Subgroup Analysis) Concomitant medication status: Taking a combination of a mood stabilizer and an antipsychotic	-13.0 Units on a scale Standard Deviation NA NA refers to standard deviation was not estimable as only 1 participant was analyzed.	—

Adverse Events

JNJ-55308942

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

Placebo

Serious events: 3 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	JNJ-55308942 n=54 participants at risk During double-blind (DB) treatment phase, participants received JNJ-55308942 capsule, orally once daily from Day 1 (Week 0) up to 6 weeks. Participants were then followed up for up to 2 weeks after their last dose (up to Day 56).	Placebo n=60 participants at risk During DB treatment phase, participants received placebo capsule (matching to JNJ-55308942), orally once daily from Day 1 (Week 0) up to 6 weeks. Participants were then followed up for up to 2 weeks after their last dose (up to Day 56).
Hepatobiliary disorders Cholelithiasis	0.00% 0/54 • All-cause mortality: From screening (-28 days) up to end of study (up to 12 weeks); SAEs and Other AEs: From Day 1 (Week 0) up to 30 days after the last dose (up to 11 weeks) All-cause mortality was analyzed on all randomized participants in the study. SAEs and Other AEs were analyzed on safety analysis set that included all randomized participants who took at least 1 dose of study intervention.	1.7% 1/60 • All-cause mortality: From screening (-28 days) up to end of study (up to 12 weeks); SAEs and Other AEs: From Day 1 (Week 0) up to 30 days after the last dose (up to 11 weeks) All-cause mortality was analyzed on all randomized participants in the study. SAEs and Other AEs were analyzed on safety analysis set that included all randomized participants who took at least 1 dose of study intervention.
Injury, poisoning and procedural complications Intentional Overdose	0.00% 0/54 • All-cause mortality: From screening (-28 days) up to end of study (up to 12 weeks); SAEs and Other AEs: From Day 1 (Week 0) up to 30 days after the last dose (up to 11 weeks) All-cause mortality was analyzed on all randomized participants in the study. SAEs and Other AEs were analyzed on safety analysis set that included all randomized participants who took at least 1 dose of study intervention.	1.7% 1/60 • All-cause mortality: From screening (-28 days) up to end of study (up to 12 weeks); SAEs and Other AEs: From Day 1 (Week 0) up to 30 days after the last dose (up to 11 weeks) All-cause mortality was analyzed on all randomized participants in the study. SAEs and Other AEs were analyzed on safety analysis set that included all randomized participants who took at least 1 dose of study intervention.
Psychiatric disorders Behaviour Disorder	0.00% 0/54 • All-cause mortality: From screening (-28 days) up to end of study (up to 12 weeks); SAEs and Other AEs: From Day 1 (Week 0) up to 30 days after the last dose (up to 11 weeks) All-cause mortality was analyzed on all randomized participants in the study. SAEs and Other AEs were analyzed on safety analysis set that included all randomized participants who took at least 1 dose of study intervention.	1.7% 1/60 • All-cause mortality: From screening (-28 days) up to end of study (up to 12 weeks); SAEs and Other AEs: From Day 1 (Week 0) up to 30 days after the last dose (up to 11 weeks) All-cause mortality was analyzed on all randomized participants in the study. SAEs and Other AEs were analyzed on safety analysis set that included all randomized participants who took at least 1 dose of study intervention.
Psychiatric disorders Depression	1.9% 1/54 • All-cause mortality: From screening (-28 days) up to end of study (up to 12 weeks); SAEs and Other AEs: From Day 1 (Week 0) up to 30 days after the last dose (up to 11 weeks) All-cause mortality was analyzed on all randomized participants in the study. SAEs and Other AEs were analyzed on safety analysis set that included all randomized participants who took at least 1 dose of study intervention.	0.00% 0/60 • All-cause mortality: From screening (-28 days) up to end of study (up to 12 weeks); SAEs and Other AEs: From Day 1 (Week 0) up to 30 days after the last dose (up to 11 weeks) All-cause mortality was analyzed on all randomized participants in the study. SAEs and Other AEs were analyzed on safety analysis set that included all randomized participants who took at least 1 dose of study intervention.
Psychiatric disorders Mania	0.00% 0/54 • All-cause mortality: From screening (-28 days) up to end of study (up to 12 weeks); SAEs and Other AEs: From Day 1 (Week 0) up to 30 days after the last dose (up to 11 weeks) All-cause mortality was analyzed on all randomized participants in the study. SAEs and Other AEs were analyzed on safety analysis set that included all randomized participants who took at least 1 dose of study intervention.	1.7% 1/60 • All-cause mortality: From screening (-28 days) up to end of study (up to 12 weeks); SAEs and Other AEs: From Day 1 (Week 0) up to 30 days after the last dose (up to 11 weeks) All-cause mortality was analyzed on all randomized participants in the study. SAEs and Other AEs were analyzed on safety analysis set that included all randomized participants who took at least 1 dose of study intervention.
Psychiatric disorders Suicide Attempt	1.9% 1/54 • All-cause mortality: From screening (-28 days) up to end of study (up to 12 weeks); SAEs and Other AEs: From Day 1 (Week 0) up to 30 days after the last dose (up to 11 weeks) All-cause mortality was analyzed on all randomized participants in the study. SAEs and Other AEs were analyzed on safety analysis set that included all randomized participants who took at least 1 dose of study intervention.	0.00% 0/60 • All-cause mortality: From screening (-28 days) up to end of study (up to 12 weeks); SAEs and Other AEs: From Day 1 (Week 0) up to 30 days after the last dose (up to 11 weeks) All-cause mortality was analyzed on all randomized participants in the study. SAEs and Other AEs were analyzed on safety analysis set that included all randomized participants who took at least 1 dose of study intervention.

Other adverse events

Other adverse events
Measure	JNJ-55308942 n=54 participants at risk During double-blind (DB) treatment phase, participants received JNJ-55308942 capsule, orally once daily from Day 1 (Week 0) up to 6 weeks. Participants were then followed up for up to 2 weeks after their last dose (up to Day 56).	Placebo n=60 participants at risk During DB treatment phase, participants received placebo capsule (matching to JNJ-55308942), orally once daily from Day 1 (Week 0) up to 6 weeks. Participants were then followed up for up to 2 weeks after their last dose (up to Day 56).
Gastrointestinal disorders Diarrhoea	3.7% 2/54 • All-cause mortality: From screening (-28 days) up to end of study (up to 12 weeks); SAEs and Other AEs: From Day 1 (Week 0) up to 30 days after the last dose (up to 11 weeks) All-cause mortality was analyzed on all randomized participants in the study. SAEs and Other AEs were analyzed on safety analysis set that included all randomized participants who took at least 1 dose of study intervention.	5.0% 3/60 • All-cause mortality: From screening (-28 days) up to end of study (up to 12 weeks); SAEs and Other AEs: From Day 1 (Week 0) up to 30 days after the last dose (up to 11 weeks) All-cause mortality was analyzed on all randomized participants in the study. SAEs and Other AEs were analyzed on safety analysis set that included all randomized participants who took at least 1 dose of study intervention.
Gastrointestinal disorders Nausea	7.4% 4/54 • All-cause mortality: From screening (-28 days) up to end of study (up to 12 weeks); SAEs and Other AEs: From Day 1 (Week 0) up to 30 days after the last dose (up to 11 weeks) All-cause mortality was analyzed on all randomized participants in the study. SAEs and Other AEs were analyzed on safety analysis set that included all randomized participants who took at least 1 dose of study intervention.	8.3% 5/60 • All-cause mortality: From screening (-28 days) up to end of study (up to 12 weeks); SAEs and Other AEs: From Day 1 (Week 0) up to 30 days after the last dose (up to 11 weeks) All-cause mortality was analyzed on all randomized participants in the study. SAEs and Other AEs were analyzed on safety analysis set that included all randomized participants who took at least 1 dose of study intervention.
Gastrointestinal disorders Vomiting	1.9% 1/54 • All-cause mortality: From screening (-28 days) up to end of study (up to 12 weeks); SAEs and Other AEs: From Day 1 (Week 0) up to 30 days after the last dose (up to 11 weeks) All-cause mortality was analyzed on all randomized participants in the study. SAEs and Other AEs were analyzed on safety analysis set that included all randomized participants who took at least 1 dose of study intervention.	5.0% 3/60 • All-cause mortality: From screening (-28 days) up to end of study (up to 12 weeks); SAEs and Other AEs: From Day 1 (Week 0) up to 30 days after the last dose (up to 11 weeks) All-cause mortality was analyzed on all randomized participants in the study. SAEs and Other AEs were analyzed on safety analysis set that included all randomized participants who took at least 1 dose of study intervention.
Nervous system disorders Headache	5.6% 3/54 • All-cause mortality: From screening (-28 days) up to end of study (up to 12 weeks); SAEs and Other AEs: From Day 1 (Week 0) up to 30 days after the last dose (up to 11 weeks) All-cause mortality was analyzed on all randomized participants in the study. SAEs and Other AEs were analyzed on safety analysis set that included all randomized participants who took at least 1 dose of study intervention.	6.7% 4/60 • All-cause mortality: From screening (-28 days) up to end of study (up to 12 weeks); SAEs and Other AEs: From Day 1 (Week 0) up to 30 days after the last dose (up to 11 weeks) All-cause mortality was analyzed on all randomized participants in the study. SAEs and Other AEs were analyzed on safety analysis set that included all randomized participants who took at least 1 dose of study intervention.

Additional Information

Senior Director Clinical Sciences Neuroscience

Janssen Research & Development

Phone: 844-434-4210

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, 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 by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days to allow for filing of a patent application.
Publication restrictions are in place

Restriction type: OTHER