Trial Outcomes & Findings for A Study of JNJ-61393215 in the Treatment of Depression (NCT NCT04080752)

NCT ID: NCT04080752

Last Updated: 2025-04-29

Results Overview

Change from baseline in HDRS-17 total score at Week 6 was reported. The HDRS-17 is a clinician-administered rating scale designed to assess the severity of symptoms in participants diagnosed with depression with a score range of 0 to 52. Each of the 17 items is rated by the clinician on either a 3-point (0 to 2) or a 5-point scale (0 to 4). The point scale used a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). A total score (range: 0 to 52) was calculated by adding the scores of all 17 items. For each item as well as the total score, a higher score represents a more severe condition (greater depression).

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 222 participants
• Primary outcome timeframe: Baseline and Week 6
• Results posted on: 2025-04-29

Participant Flow

Participant milestones

Measure	Placebo After a screening period of up to 4 weeks duration, participants received placebo matching to JNJ-61393215 capsule orally once daily during 6 weeks double-blind treatment period, followed by 2 weeks post treatment follow-up period. Throughout the study, participants continued their standard treatment of oral antidepressants at an adequate and tolerated stable dose.	JNJ-61393215 135 Milligrams (mg) After a screening period of up to 4 weeks duration, participants received JNJ-61393215 135 mg (3\*45 mg) capsule orally once daily during 6 weeks double-blind treatment period, followed by 2 weeks post treatment follow-up period. Throughout the study, participants continued their standard treatment of oral antidepressants at an adequate and tolerated stable dose.
Overall Study STARTED	112	110
Overall Study COMPLETED	99	104
Overall Study NOT COMPLETED	13	6

Reasons for withdrawal

Measure	Placebo After a screening period of up to 4 weeks duration, participants received placebo matching to JNJ-61393215 capsule orally once daily during 6 weeks double-blind treatment period, followed by 2 weeks post treatment follow-up period. Throughout the study, participants continued their standard treatment of oral antidepressants at an adequate and tolerated stable dose.	JNJ-61393215 135 Milligrams (mg) After a screening period of up to 4 weeks duration, participants received JNJ-61393215 135 mg (3\*45 mg) capsule orally once daily during 6 weeks double-blind treatment period, followed by 2 weeks post treatment follow-up period. Throughout the study, participants continued their standard treatment of oral antidepressants at an adequate and tolerated stable dose.
Overall Study Adverse Event	2	3
Overall Study Lack of Efficacy	1	0
Overall Study Lost to Follow-up	1	0
Overall Study Pregnancy	0	1
Overall Study Withdrawal by Subject	7	0
Overall Study Non-Compliance with Study Drug	0	1
Overall Study Other	2	1

Baseline Characteristics

A Study of JNJ-61393215 in the Treatment of Depression

Baseline characteristics by cohort

Measure	Placebo n=112 Participants After a screening period of up to 4 weeks duration, participants received placebo matching to JNJ-61393215 capsule orally once daily during 6 weeks double-blind treatment period, followed by 2 weeks post treatment follow-up period. Throughout the study, participants continued their standard treatment of oral antidepressants at an adequate and tolerated stable dose.	JNJ-61393215 135 Milligrams (mg) n=110 Participants After a screening period of up to 4 weeks duration, participants received JNJ-61393215 135 mg (3\*45 mg) capsule orally once daily during 6 weeks double-blind treatment period, followed by 2 weeks post treatment follow-up period. Throughout the study, participants continued their standard treatment of oral antidepressants at an adequate and tolerated stable dose.	Total n=222 Participants Total of all reporting groups
Age, Continuous	39.9 years STANDARD_DEVIATION 12.99 • n=5 Participants	43.6 years STANDARD_DEVIATION 12.39 • n=7 Participants	41.7 years STANDARD_DEVIATION 12.8 • n=5 Participants
Sex: Female, Male Female	79 Participants n=5 Participants	88 Participants n=7 Participants	167 Participants n=5 Participants
Sex: Female, Male Male	33 Participants n=5 Participants	22 Participants n=7 Participants	55 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	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	13 Participants n=5 Participants	13 Participants n=7 Participants	26 Participants n=5 Participants
Race (NIH/OMB) White	97 Participants n=5 Participants	95 Participants n=7 Participants	192 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 MOLDOVA, REPUBLIC OF	18 Participants n=5 Participants	17 Participants n=7 Participants	35 Participants n=5 Participants
Region of Enrollment RUSSIAN FEDERATION	36 Participants n=5 Participants	34 Participants n=7 Participants	70 Participants n=5 Participants
Region of Enrollment UKRAINE	22 Participants n=5 Participants	21 Participants n=7 Participants	43 Participants n=5 Participants
Region of Enrollment UNITED KINGDOM	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants
Region of Enrollment UNITED STATES	26 Participants n=5 Participants	29 Participants n=7 Participants	55 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Week 6

Population: The enriched analysis set (EAS) included all randomized participants who received at least 1 dose of study agent and had improvement in percent changes in HDRS17 total score less than (\<)25 percent (%) from screening to baseline and HDRS-17 total score greater than or equal to (\>=)18 at baseline. Here, 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.

Change from baseline in HDRS-17 total score at Week 6 was reported. The HDRS-17 is a clinician-administered rating scale designed to assess the severity of symptoms in participants diagnosed with depression with a score range of 0 to 52. Each of the 17 items is rated by the clinician on either a 3-point (0 to 2) or a 5-point scale (0 to 4). The point scale used a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). A total score (range: 0 to 52) was calculated by adding the scores of all 17 items. For each item as well as the total score, a higher score represents a more severe condition (greater depression).

Outcome measures

Measure	Placebo n=97 Participants After a screening period of up to 4 weeks duration, participants received placebo matching to JNJ-61393215 capsule orally once daily during 6 weeks double-blind treatment period, followed by 2 weeks post treatment follow-up period. Throughout the study, participants continued their standard treatment of oral antidepressants at an adequate and tolerated stable dose.	JNJ-61393215 135 Milligrams (mg) n=103 Participants After a screening period of up to 4 weeks duration, participants received JNJ-61393215 135 mg (3\*45 mg) capsule orally once daily during 6 weeks double-blind treatment period, followed by 2 weeks post treatment follow-up period. Throughout the study, participants continued their standard treatment of oral antidepressants at an adequate and tolerated stable dose.
Change From Baseline in Hamilton Depression Rating Scale-17 (HDRS-17) Total Score at Week 6	-8.8 Units on a scale Standard Error 0.66	-9.4 Units on a scale Standard Error 0.64

SECONDARY outcome

Timeframe: Baseline and Week 6

Population: The EAS included all randomized participants who received at least 1 dose of study agent and had improvement in percent changes in HDRS17 total score \<25% from screening to baseline and HDRS-17 total score \>=18 at baseline. Here, 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.

Change from baseline in HAM-A total score at Week 6 was reported. HAM-A is a 14-item scale designed to measure severity of anxiety-related symptoms in participants. Each question reflects a symptom of general anxiety, including physical anxiety and mental anxiety. Each item was rated on a 5-point scale ranged from 0 (not present) to 4 (maximum anxiety). The total score was sum of 14 items scores and it ranged from 0 (normal) to 56 (severe), where higher score indicated greater degree of anxiety symptom. The total score was categorized as 0-13: normal range, 14-17: mild severity, 18-24: mild to moderate severity, 25-30: moderate to severe, and >=31: severe. Negative change in score indicates improvement.

Outcome measures

Measure	Placebo n=97 Participants After a screening period of up to 4 weeks duration, participants received placebo matching to JNJ-61393215 capsule orally once daily during 6 weeks double-blind treatment period, followed by 2 weeks post treatment follow-up period. Throughout the study, participants continued their standard treatment of oral antidepressants at an adequate and tolerated stable dose.	JNJ-61393215 135 Milligrams (mg) n=103 Participants After a screening period of up to 4 weeks duration, participants received JNJ-61393215 135 mg (3\*45 mg) capsule orally once daily during 6 weeks double-blind treatment period, followed by 2 weeks post treatment follow-up period. Throughout the study, participants continued their standard treatment of oral antidepressants at an adequate and tolerated stable dose.
Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score at Week 6	-10.4 Units on a scale Standard Error 0.74	-10.3 Units on a scale Standard Error 0.72

SECONDARY outcome

Timeframe: Baseline, Week 2, and Week 4

Population: The EAS included all randomized participants who received at least 1 dose of study agent and had improvement in percent changes in HDRS17 total score \<25% from screening to baseline and HDRS-17 total score \>=18 at baseline. Here, 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. Here, 'n' (number analyzed) signifies participants evaluable for this outcome measure at specified time points.

Change from baseline in HAM-A total score at Weeks 2 and 4 were reported. HAM-A is a 14-item scale designed to measure severity of anxiety-related symptoms in participants. Each question reflects a symptom of general anxiety, including physical anxiety and mental anxiety. Each item was rated on a 5-point scale ranged from 0 (not present) to 4 (maximum anxiety). The total score was sum of 14 items scores and it ranged from 0 (normal) to 56 (severe), where higher score indicated greater degree of anxiety symptom. The total score was categorized as 0-13: normal range, 14-17: mild severity, 18-24: mild to moderate severity, 25-30: moderate to severe, and >=31: severe. Negative change in score indicates improvement.

Outcome measures

Measure	Placebo n=105 Participants After a screening period of up to 4 weeks duration, participants received placebo matching to JNJ-61393215 capsule orally once daily during 6 weeks double-blind treatment period, followed by 2 weeks post treatment follow-up period. Throughout the study, participants continued their standard treatment of oral antidepressants at an adequate and tolerated stable dose.	JNJ-61393215 135 Milligrams (mg) n=108 Participants After a screening period of up to 4 weeks duration, participants received JNJ-61393215 135 mg (3\*45 mg) capsule orally once daily during 6 weeks double-blind treatment period, followed by 2 weeks post treatment follow-up period. Throughout the study, participants continued their standard treatment of oral antidepressants at an adequate and tolerated stable dose.
Change From Baseline in HAM-A Total Score at Weeks 2 and 4 Week 2	-4.85 Units on a scale Standard Error 0.511	-4.1 Units on a scale Standard Error 0.505
Change From Baseline in HAM-A Total Score at Weeks 2 and 4 Week 4	-8.05 Units on a scale Standard Error 0.616	-7.9 Units on a scale Standard Error 0.603

SECONDARY outcome

Timeframe: Baseline and Week 6

Population: The analyzed population included participants of EAS who had baseline HAM-A Score of \>=20.

Change from baseline in HDRS-17 total score in participants with a baseline HAM-A score >=20 at Week 6 was reported. The HDRS-17 is a clinician-administered rating scale designed to assess the severity of symptoms in participants diagnosed with depression with a score range of 0 to 52. Each of the 17 items is rated by the clinician on either a 3-point (0 to 2) or a 5-point scale (0 to 4). The point scale used a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). A total score (range: 0 to 52) was calculated by adding the scores of all 17 items. For each item as well as the total score, a higher score represents a more severe condition (greater depression).

Outcome measures

Measure	Placebo n=91 Participants After a screening period of up to 4 weeks duration, participants received placebo matching to JNJ-61393215 capsule orally once daily during 6 weeks double-blind treatment period, followed by 2 weeks post treatment follow-up period. Throughout the study, participants continued their standard treatment of oral antidepressants at an adequate and tolerated stable dose.	JNJ-61393215 135 Milligrams (mg) n=94 Participants After a screening period of up to 4 weeks duration, participants received JNJ-61393215 135 mg (3\*45 mg) capsule orally once daily during 6 weeks double-blind treatment period, followed by 2 weeks post treatment follow-up period. Throughout the study, participants continued their standard treatment of oral antidepressants at an adequate and tolerated stable dose.
Change From Baseline in HDRS-17 Total Score in Participants With a Baseline HAM-A Score >=20 at Week 6	-8.8 Units on a scale Standard Error 0.68	-9.8 Units on a scale Standard Error 0.67

SECONDARY outcome

Timeframe: Baseline and Week 6

Population: The analyzed population included participants of EAS who had baseline HAM-A Score of \>=20.

Change from baseline in HAM-A total score in participants with a baseline HAM-A score >=20 at Week 6 was reported. HAM-A is a 14-item scale designed to measure severity of anxiety-related symptoms in participants. Each question reflects a symptom of general anxiety, including physical anxiety and mental anxiety. Each item was rated on a 5-point scale ranged from 0 (not present) to 4 (maximum anxiety). The total score was sum of 14 items scores and it ranged from 0 (normal) to 56 (severe), where higher score indicated greater degree of anxiety symptom. The total score was categorized as 0-13: normal range, 14-17: mild severity, 18-24: mild to moderate severity, 25-30: moderate to severe, and >=31: severe. Negative change in score indicates improvement.

Outcome measures

Measure	Placebo n=91 Participants After a screening period of up to 4 weeks duration, participants received placebo matching to JNJ-61393215 capsule orally once daily during 6 weeks double-blind treatment period, followed by 2 weeks post treatment follow-up period. Throughout the study, participants continued their standard treatment of oral antidepressants at an adequate and tolerated stable dose.	JNJ-61393215 135 Milligrams (mg) n=94 Participants After a screening period of up to 4 weeks duration, participants received JNJ-61393215 135 mg (3\*45 mg) capsule orally once daily during 6 weeks double-blind treatment period, followed by 2 weeks post treatment follow-up period. Throughout the study, participants continued their standard treatment of oral antidepressants at an adequate and tolerated stable dose.
Change From Baseline in HAM-A Total Score in Participants With a Baseline HAM-A Score >=20 at Week 6	-10.6 Units on a scale Standard Error 0.78	-10.9 Units on a scale Standard Error 0.77

SECONDARY outcome

Timeframe: Baseline and Week 6

Population: The EAS included all randomized participants who received at least 1 dose of study agent and had improvement in percent changes in HDRS17 total score \<25% from screening to baseline and HDRS-17 total score \>=18 at baseline. Here, 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.

Change from baseline in GAD-7 total score at Week 6 was reported. The GAD-7 is a brief and validated 7-item self-reported assessment of overall anxiety. Participants respond 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. Item responses are summed to yield a total score with a range of 0 to 21, where higher scores indicate more anxiety. The recall period is 2 weeks. The severity of the GAD-7 is categorized as follows: None (0-4), Mild (5-9), Moderate (10-14) and Severe (15-21).

Outcome measures

Measure	Placebo n=97 Participants After a screening period of up to 4 weeks duration, participants received placebo matching to JNJ-61393215 capsule orally once daily during 6 weeks double-blind treatment period, followed by 2 weeks post treatment follow-up period. Throughout the study, participants continued their standard treatment of oral antidepressants at an adequate and tolerated stable dose.	JNJ-61393215 135 Milligrams (mg) n=102 Participants After a screening period of up to 4 weeks duration, participants received JNJ-61393215 135 mg (3\*45 mg) capsule orally once daily during 6 weeks double-blind treatment period, followed by 2 weeks post treatment follow-up period. Throughout the study, participants continued their standard treatment of oral antidepressants at an adequate and tolerated stable dose.
Change From Baseline in Generalized Anxiety Disorder-7 (GAD-7) Total Score at Week 6	-5.3 Units on a scale Standard Error 0.52	-5.7 Units on a scale Standard Error 0.51

SECONDARY outcome

Timeframe: Baseline, Week 2, and Week 4

Population: The EAS included all randomized participants who received at least 1 dose of study agent and had improvement in percent changes in HDRS17 total score \<25% from screening to baseline and HDRS-17 total score \>=18 at baseline. Here, 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. Here, 'n' (number analyzed) signifies participants evaluable for this outcome measure at specified time points.

Change From baseline in PHQ-9 total score at Weeks 2 and 4. The PHQ-9 is a 9-item, Patient Reported Outcome (PRO) 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) major depressive disorder (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 participants 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

Measure	Placebo n=105 Participants After a screening period of up to 4 weeks duration, participants received placebo matching to JNJ-61393215 capsule orally once daily during 6 weeks double-blind treatment period, followed by 2 weeks post treatment follow-up period. Throughout the study, participants continued their standard treatment of oral antidepressants at an adequate and tolerated stable dose.	JNJ-61393215 135 Milligrams (mg) n=108 Participants After a screening period of up to 4 weeks duration, participants received JNJ-61393215 135 mg (3\*45 mg) capsule orally once daily during 6 weeks double-blind treatment period, followed by 2 weeks post treatment follow-up period. Throughout the study, participants continued their standard treatment of oral antidepressants at an adequate and tolerated stable dose.
Change From Baseline in Patient Health Questionnaire (PHQ-9) Total Score at Weeks 2 and 4 Week 2	-3.26 Units on a scale Standard Error 0.461	-2.84 Units on a scale Standard Error 0.455
Change From Baseline in Patient Health Questionnaire (PHQ-9) Total Score at Weeks 2 and 4 Week 4	-5.63 Units on a scale Standard Error 0.557	-5.71 Units on a scale Standard Error 0.544

SECONDARY outcome

Timeframe: Baseline, Week 2, and Week 4

Population: The EAS included all randomized participants who received at least 1 dose of study agent and had improvement in percent changes in HDRS17 total score \<25% from screening to baseline and HDRS-17 total score \>=18 at baseline. Here, 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. Here, 'n' (number analyzed) signifies participants evaluable for this outcome measure at specified time points.

Change From baseline in HDRS-17 total score at Weeks 2 and 4. The HDRS-17 is a clinician-administered rating scale designed to assess the severity of symptoms in participants diagnosed with depression with a score range of 0 to 52. Each of the 17 items is rated by the clinician on either a 3-point (0 to 2) or a 5-point scale (0 to 4). The point scale used a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). A total score (range: 0 to 52) was calculated by adding the scores of all 17 items. For each item as well as the total score, a higher score represents a more severe condition (greater depression).

Outcome measures

Measure	Placebo n=105 Participants After a screening period of up to 4 weeks duration, participants received placebo matching to JNJ-61393215 capsule orally once daily during 6 weeks double-blind treatment period, followed by 2 weeks post treatment follow-up period. Throughout the study, participants continued their standard treatment of oral antidepressants at an adequate and tolerated stable dose.	JNJ-61393215 135 Milligrams (mg) n=108 Participants After a screening period of up to 4 weeks duration, participants received JNJ-61393215 135 mg (3\*45 mg) capsule orally once daily during 6 weeks double-blind treatment period, followed by 2 weeks post treatment follow-up period. Throughout the study, participants continued their standard treatment of oral antidepressants at an adequate and tolerated stable dose.
Change From Baseline in HDRS-17 Total Score at Weeks 2 and 4 Week 2	-3.98 Units on a scale Standard Error 0.47	-3.54 Units on a scale Standard Error 0.465
Change From Baseline in HDRS-17 Total Score at Weeks 2 and 4 Week 4	-6.78 Units on a scale Standard Error 0.546	-7.03 Units on a scale Standard Error 0.536

SECONDARY outcome

Timeframe: Up to 8 weeks

Population: The safety analysis set included all randomized participants who received at least 1 dose of study agent.

An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs were events during the initiation of study drug up till follow-up period.

Outcome measures

Measure	Placebo n=112 Participants After a screening period of up to 4 weeks duration, participants received placebo matching to JNJ-61393215 capsule orally once daily during 6 weeks double-blind treatment period, followed by 2 weeks post treatment follow-up period. Throughout the study, participants continued their standard treatment of oral antidepressants at an adequate and tolerated stable dose.	JNJ-61393215 135 Milligrams (mg) n=110 Participants After a screening period of up to 4 weeks duration, participants received JNJ-61393215 135 mg (3\*45 mg) capsule orally once daily during 6 weeks double-blind treatment period, followed by 2 weeks post treatment follow-up period. Throughout the study, participants continued their standard treatment of oral antidepressants at an adequate and tolerated stable dose.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability	34 Participants	50 Participants

SECONDARY outcome

Timeframe: 1-4 hours postdose on Day 1; Predose and 1-4 hours post dose on Days 15, 29, and 43

Population: Analysis population included participant who received JNJ-61393215 and for whom at least one pharmacokinetic (PK) concentration was available. Here, 'n' (number analyzed) signifies participants evaluable for this outcome measure at specified time points.

Total plasma concentration of JNJ-61393215 was reported. The concentrations of JNJ-61393215 were measured using a validated, specific, and sensitive liquid chromatography-mass spectrometry/mass spectrometry (LC-MS/MS) method.

Outcome measures

Measure	Placebo n=106 Participants After a screening period of up to 4 weeks duration, participants received placebo matching to JNJ-61393215 capsule orally once daily during 6 weeks double-blind treatment period, followed by 2 weeks post treatment follow-up period. Throughout the study, participants continued their standard treatment of oral antidepressants at an adequate and tolerated stable dose.	JNJ-61393215 135 Milligrams (mg) After a screening period of up to 4 weeks duration, participants received JNJ-61393215 135 mg (3\*45 mg) capsule orally once daily during 6 weeks double-blind treatment period, followed by 2 weeks post treatment follow-up period. Throughout the study, participants continued their standard treatment of oral antidepressants at an adequate and tolerated stable dose.
Total Plasma Concentration of JNJ-61393215 Day 1: 1-4 hours postdose	4143 Nanograms per milliter (ng/mL) Standard Deviation 2315	—
Total Plasma Concentration of JNJ-61393215 Day 15: Predose	3053 Nanograms per milliter (ng/mL) Standard Deviation 1857	—
Total Plasma Concentration of JNJ-61393215 Day 15: 1-4 hours postdose	5638 Nanograms per milliter (ng/mL) Standard Deviation 2362	—
Total Plasma Concentration of JNJ-61393215 Day 29: Predose	3104 Nanograms per milliter (ng/mL) Standard Deviation 1839	—
Total Plasma Concentration of JNJ-61393215 Day 29: 1-4 hours postdose	5868 Nanograms per milliter (ng/mL) Standard Deviation 2267	—
Total Plasma Concentration of JNJ-61393215 Day 43: Predose	3019 Nanograms per milliter (ng/mL) Standard Deviation 1794	—
Total Plasma Concentration of JNJ-61393215 Day 43: 1-4 hours postdose	5897 Nanograms per milliter (ng/mL) Standard Deviation 2288	—

SECONDARY outcome

Timeframe: Predose and 1-4 hours post dose on Day 43

Population: Analysis population included participant who received JNJ-61393215 and for whom PPB assessment was performed.

Percentage of JNJ-61393215 unbound was determined by using a liquid chromatography-mass spectrometry/mass spectrometry (LC-MS/MS) method. The protein binding was assessed by spiking plasma samples with radiolabeled JNJ-61393215.

Outcome measures

Measure	Placebo n=94 Participants After a screening period of up to 4 weeks duration, participants received placebo matching to JNJ-61393215 capsule orally once daily during 6 weeks double-blind treatment period, followed by 2 weeks post treatment follow-up period. Throughout the study, participants continued their standard treatment of oral antidepressants at an adequate and tolerated stable dose.	JNJ-61393215 135 Milligrams (mg) After a screening period of up to 4 weeks duration, participants received JNJ-61393215 135 mg (3\*45 mg) capsule orally once daily during 6 weeks double-blind treatment period, followed by 2 weeks post treatment follow-up period. Throughout the study, participants continued their standard treatment of oral antidepressants at an adequate and tolerated stable dose.
Plasma Protein Binding (PPB): Percentage of JNJ-61393215 Unbound Day 43: Predose	2.52 Percentage of JNJ-61393215 unbound Standard Deviation 0.776	—
Plasma Protein Binding (PPB): Percentage of JNJ-61393215 Unbound Day 43: 1-4 hours postdose	4.15 Percentage of JNJ-61393215 unbound Standard Deviation 1.58	—

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

JNJ-61393215 135 Milligrams (mg)

Serious events: 0 serious events

Other events: 30 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Placebo n=112 participants at risk After a screening period of up to 4 weeks duration, participants received placebo matching to JNJ-61393215 capsule orally once daily during 6 weeks double-blind treatment period, followed by 2 weeks post treatment follow-up period. Throughout the study, participants continued their standard treatment of oral antidepressants at an adequate and tolerated stable dose.	JNJ-61393215 135 Milligrams (mg) n=110 participants at risk After a screening period of up to 4 weeks duration, participants received JNJ-61393215 135 mg (3\*45 mg) capsule orally once daily during 6 weeks double-blind treatment period, followed by 2 weeks post treatment follow-up period. Throughout the study, participants continued their standard treatment of oral antidepressants at an adequate and tolerated stable dose.
Gastrointestinal disorders Abdominal Pain	2.7% 3/112 • Up to 8 weeks The safety analysis set included all randomized participants who received at least 1 dose of study agent.	0.00% 0/110 • Up to 8 weeks The safety analysis set included all randomized participants who received at least 1 dose of study agent.
Gastrointestinal disorders Diarrhoea	0.00% 0/112 • Up to 8 weeks The safety analysis set included all randomized participants who received at least 1 dose of study agent.	3.6% 4/110 • Up to 8 weeks The safety analysis set included all randomized participants who received at least 1 dose of study agent.
Gastrointestinal disorders Nausea	0.89% 1/112 • Up to 8 weeks The safety analysis set included all randomized participants who received at least 1 dose of study agent.	5.5% 6/110 • Up to 8 weeks The safety analysis set included all randomized participants who received at least 1 dose of study agent.
General disorders Fatigue	0.00% 0/112 • Up to 8 weeks The safety analysis set included all randomized participants who received at least 1 dose of study agent.	2.7% 3/110 • Up to 8 weeks The safety analysis set included all randomized participants who received at least 1 dose of study agent.
Infections and infestations Urinary Tract Infection	0.00% 0/112 • Up to 8 weeks The safety analysis set included all randomized participants who received at least 1 dose of study agent.	2.7% 3/110 • Up to 8 weeks The safety analysis set included all randomized participants who received at least 1 dose of study agent.
Nervous system disorders Headache	8.0% 9/112 • Up to 8 weeks The safety analysis set included all randomized participants who received at least 1 dose of study agent.	11.8% 13/110 • Up to 8 weeks The safety analysis set included all randomized participants who received at least 1 dose of study agent.
Nervous system disorders Somnolence	0.00% 0/112 • Up to 8 weeks The safety analysis set included all randomized participants who received at least 1 dose of study agent.	8.2% 9/110 • Up to 8 weeks The safety analysis set included all randomized participants who received at least 1 dose of study agent.

Additional Information

BE-R and D-Research Physician - Seni

Janssen Research & Development, LLC

Phone: 844-434-4210

Email: ClinicalTrialDisclosure@its.jnj.com

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