Trial Outcomes & Findings for A Study of Seltorexant as Adjunctive Therapy to Antidepressants in Adult and Elderly Participants With Major Depressive Disorder With Insomnia Symptoms Who Have Responded Inadequately to Antidepressant Therapy (NCT NCT04532749)

Last Updated: 2025-06-04

Results Overview

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

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

212 participants

Primary outcome timeframe

Baseline (Day 1), Day 43

Results posted on

2025-06-04

Participant Flow

Participants with major depressive disorder with insomnia symptoms (MDDIS) who had an inadequate response to an ongoing antidepressant therapy with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI) were randomized in the study. Study consisted of screening phase, double-blind (DB) treatment phase and a post-treatment follow-up (FU) phase.

Participant milestones

Participant milestones
Measure	Seltorexant During DB treatment phase, participants received seltorexant 20 milligrams (mg) tablet orally once daily from Day 1 to Day 42. Participants were then followed up for safety up to 7 to 14 days after end of DB treatment at Day 43 (up to Day 57) during the follow-up phase. Participants who discontinued study drug prior to Day 35 were encouraged to have additional follow-up visits every 2 weeks until Day 50 to 57.	Placebo During DB treatment phase, participants received placebo matching to seltorexant tablet orally once daily from Day 1 to Day 42. Participants were then followed up for safety up to 7 to 14 days after end of DB treatment at Day 43 (up to Day 57) during the follow-up phase. Participants who discontinued study drug prior to Day 35 were encouraged to have additional follow-up visits every 2 weeks until Day 50 to 57.
DB Treatment Phase (Day 1 to Day 43) STARTED	107	105
DB Treatment Phase (Day 1 to Day 43) COMPLETED	101	89
DB Treatment Phase (Day 1 to Day 43) NOT COMPLETED	6	16
Follow-up Phase (Day 44 to Day 57) STARTED	103	98
Follow-up Phase (Day 44 to Day 57) COMPLETED	102	92
Follow-up Phase (Day 44 to Day 57) NOT COMPLETED	1	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Seltorexant During DB treatment phase, participants received seltorexant 20 milligrams (mg) tablet orally once daily from Day 1 to Day 42. Participants were then followed up for safety up to 7 to 14 days after end of DB treatment at Day 43 (up to Day 57) during the follow-up phase. Participants who discontinued study drug prior to Day 35 were encouraged to have additional follow-up visits every 2 weeks until Day 50 to 57.	Placebo During DB treatment phase, participants received placebo matching to seltorexant tablet orally once daily from Day 1 to Day 42. Participants were then followed up for safety up to 7 to 14 days after end of DB treatment at Day 43 (up to Day 57) during the follow-up phase. Participants who discontinued study drug prior to Day 35 were encouraged to have additional follow-up visits every 2 weeks until Day 50 to 57.
DB Treatment Phase (Day 1 to Day 43) Adverse Event	1	6
DB Treatment Phase (Day 1 to Day 43) Lack of Efficacy	2	5
DB Treatment Phase (Day 1 to Day 43) Withdrawal by Subject	2	0
DB Treatment Phase (Day 1 to Day 43) Lost to Follow-up	0	1
DB Treatment Phase (Day 1 to Day 43) Protocol Violation	0	1
DB Treatment Phase (Day 1 to Day 43) Study Terminated by Sponsor	0	1
DB Treatment Phase (Day 1 to Day 43) Other	1	2
Follow-up Phase (Day 44 to Day 57) Withdrawal by Subject	0	3
Follow-up Phase (Day 44 to Day 57) Adverse Event	0	1
Follow-up Phase (Day 44 to Day 57) Other	1	2

Baseline Characteristics

A Study of Seltorexant as Adjunctive Therapy to Antidepressants in Adult and Elderly Participants With Major Depressive Disorder With Insomnia Symptoms Who Have Responded Inadequately to Antidepressant Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Seltorexant n=107 Participants During DB treatment phase, participants received seltorexant 20 mg tablet orally once daily from Day 1 to Day 42. Participants were then followed up for safety up to 7 to 14 days after end of DB treatment at Day 43 (up to Day 57) during the follow-up phase. Participants who discontinued study drug prior to Day 35 were encouraged to have additional follow-up visits every 2 weeks until Day 50 to 57.	Placebo n=105 Participants During DB treatment phase, participants received placebo matching to seltorexant tablet orally once daily from Day 1 to Day 42. Participants were then followed up for safety up to 7 to 14 days after end of DB treatment at Day 43 (up to Day 57) during the follow-up phase. Participants who discontinued study drug prior to Day 35 were encouraged to have additional follow-up visits every 2 weeks until Day 50 to 57.	Total n=212 Participants Total of all reporting groups
Age, Continuous	50.2 Years STANDARD_DEVIATION 13.87 • n=5 Participants	48.8 Years STANDARD_DEVIATION 14.40 • n=7 Participants	49.5 Years STANDARD_DEVIATION 14.12 • n=5 Participants
Sex: Female, Male Female	78 Participants n=5 Participants	83 Participants n=7 Participants	161 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants	22 Participants n=7 Participants	51 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	38 Participants n=5 Participants	33 Participants n=7 Participants	71 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	68 Participants n=5 Participants	72 Participants n=7 Participants	140 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 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	5 Participants n=5 Participants	4 Participants n=7 Participants	9 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	9 Participants n=5 Participants	14 Participants n=7 Participants	23 Participants n=5 Participants
Race (NIH/OMB) White	90 Participants n=5 Participants	87 Participants n=7 Participants	177 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	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment Argentina	13 Participants n=5 Participants	14 Participants n=7 Participants	27 Participants n=5 Participants
Region of Enrollment Chile	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Region of Enrollment Denmark	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment Finland	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants
Region of Enrollment Malaysia	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment Poland	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Region of Enrollment Slovakia	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Region of Enrollment Korea, South	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Region of Enrollment Ukraine	23 Participants n=5 Participants	25 Participants n=7 Participants	48 Participants n=5 Participants
Region of Enrollment United States	38 Participants n=5 Participants	36 Participants n=7 Participants	74 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1), Day 43

Population: The full analysis set 1 (FAS1) included all randomized participants who received at least 1 dose of study intervention in the DB phase and had baseline MADRS total score greater than or equal to (\>=) 24 (per interactive web response system \[IWRS\]). Here 'N' (overall number of participants analyzed) refers to the number of participants evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Seltorexant n=101 Participants During DB treatment phase, participants received seltorexant 20 mg tablet orally once daily from Day 1 to Day 42. Participants were then followed up for safety up to 7 to 14 days after end of DB treatment at Day 43 (up to Day 57) during the follow-up phase. Participants who discontinued study drug prior to Day 35 were encouraged to have additional follow-up visits every 2 weeks until Day 50 to 57.	Placebo n=89 Participants During DB treatment phase, participants received placebo matching to seltorexant tablet orally once daily from Day 1 to Day 42. Participants were then followed up for safety up to 7 to 14 days after end of DB treatment at Day 43 (up to Day 57) during the follow-up phase. Participants who discontinued study drug prior to Day 35 were encouraged to have additional follow-up visits every 2 weeks until Day 50 to 57.
Change From Baseline to Day 43 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score	-14.0 Units on a scale Standard Deviation 10.46	-13.1 Units on a scale Standard Deviation 9.51

SECONDARY outcome

Timeframe: Baseline (Day 1), Day 43

Population: FAS1 included all randomized participants who received at least 1 dose of study intervention in the DB phase and had baseline MADRS total score \>=24 (per IWRS). Here 'N' (overall number of participants analyzed) refers to the number of participants evaluable for this outcome measure.

The MADRS was a clinician-rated scale designed to measure depression severity and detected changes due to antidepressant treatment. MADRS-WOSI was defined as the full MADRS without the sleep item. The MADRS-WOSI scale consisted of 9 items (apparent sadness, reported sadness, inner tension, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts), each of which was scored from 0 (item not present or normal) to 6 (severe or continuous presence of symptoms). Higher scores represented a more severe condition. MADRS-WOSI total score was the sum of scores from individual question items, which ranged from 0 to 54, higher scores represented a more severe condition. Negative change in MADRS total score indicated improvement.

Outcome measures

Outcome measures
Measure	Seltorexant n=101 Participants During DB treatment phase, participants received seltorexant 20 mg tablet orally once daily from Day 1 to Day 42. Participants were then followed up for safety up to 7 to 14 days after end of DB treatment at Day 43 (up to Day 57) during the follow-up phase. Participants who discontinued study drug prior to Day 35 were encouraged to have additional follow-up visits every 2 weeks until Day 50 to 57.	Placebo n=89 Participants During DB treatment phase, participants received placebo matching to seltorexant tablet orally once daily from Day 1 to Day 42. Participants were then followed up for safety up to 7 to 14 days after end of DB treatment at Day 43 (up to Day 57) during the follow-up phase. Participants who discontinued study drug prior to Day 35 were encouraged to have additional follow-up visits every 2 weeks until Day 50 to 57.
Change From Baseline to Day 43 in the MADRS Without Sleep Item (MADRS-WOSI) Total Score	-12.0 Units on a scale Standard Deviation 9.27	-11.3 Units on a scale Standard Deviation 8.44

SECONDARY outcome

Timeframe: Baseline (Day 1), Day 43

PROMIS-SD Short Form 8a: static 8-item questionnaire, assessed self-perceptions of sleep initiation (2 items), quality of sleep (3 items), early morning feelings (2 items), worrying about sleep (1 item). Each question has 5 options ranged 1 to 5. The "direction" of responses was not same, sometimes "not at all" =more sleep disturbance; sometimes "not at all" =less sleep disturbance. Total raw score for short form with all questions answered was sum of values of response to each question, total score ranged 8 to 40. Lower scores=less sleep disturbance. Total raw score converted into T-score. T-score rescaled the raw score into standardized score with mean-50; SD-10. Negative changes in scores=improvement. Higher PROMIS T-score represents more concept measured. Negatively worded (like sleep disturbance), T-score of 60 was one SD worse than average. By comparison, T-score of 40 was one SD better than average. T-score of 50 or above was clinically significant level of sleep disturbance.

Outcome measures

Outcome measures
Measure	Seltorexant n=101 Participants During DB treatment phase, participants received seltorexant 20 mg tablet orally once daily from Day 1 to Day 42. Participants were then followed up for safety up to 7 to 14 days after end of DB treatment at Day 43 (up to Day 57) during the follow-up phase. Participants who discontinued study drug prior to Day 35 were encouraged to have additional follow-up visits every 2 weeks until Day 50 to 57.	Placebo n=89 Participants During DB treatment phase, participants received placebo matching to seltorexant tablet orally once daily from Day 1 to Day 42. Participants were then followed up for safety up to 7 to 14 days after end of DB treatment at Day 43 (up to Day 57) during the follow-up phase. Participants who discontinued study drug prior to Day 35 were encouraged to have additional follow-up visits every 2 weeks until Day 50 to 57.
Change From Baseline to Day 43 in Sleep Disturbance Using the Patient Reported Outcome Measurement Information System-Sleep Disturbance (PROMIS-SD; Short Form 8a) T-score	-13.7 T-score Standard Deviation 11.06	-11.9 T-score Standard Deviation 11.83

SECONDARY outcome

Timeframe: Baseline (Day 1), Day 43

The 6-item MADRS was a clinician-administered scale designed to measure the core symptoms of depression severity and detected changes due to antidepressant intervention. It is a subset of MADRS (10-item). The MADRS-6 subscale score was the sum of scores for the following MADRS items: apparent sadness, reported sadness, inner tension, lassitude, inability to feel, and pessimistic thoughts. Each item was scored from 0 (item not present or normal) to 6 (severe or continuous presence of symptoms), the overall score ranges from 0 to 36, higher scores represented a more severe condition. Negative changes in MADRS-6 total score indicate improvement.

Outcome measures

Outcome measures
Measure	Seltorexant n=101 Participants During DB treatment phase, participants received seltorexant 20 mg tablet orally once daily from Day 1 to Day 42. Participants were then followed up for safety up to 7 to 14 days after end of DB treatment at Day 43 (up to Day 57) during the follow-up phase. Participants who discontinued study drug prior to Day 35 were encouraged to have additional follow-up visits every 2 weeks until Day 50 to 57.	Placebo n=89 Participants During DB treatment phase, participants received placebo matching to seltorexant tablet orally once daily from Day 1 to Day 42. Participants were then followed up for safety up to 7 to 14 days after end of DB treatment at Day 43 (up to Day 57) during the follow-up phase. Participants who discontinued study drug prior to Day 35 were encouraged to have additional follow-up visits every 2 weeks until Day 50 to 57.
Change From Baseline to Day 43 in the 6-item MADRS (MADRS-6) Total Score	-9.1 Units on a scale Standard Deviation 6.86	-8.1 Units on a scale Standard Deviation 6.37

SECONDARY outcome

Timeframe: At Day 43

Population: FAS1 included all randomized participants who received at least 1 dose of study intervention in the DB phase and had baseline MADRS total score \>=24 (per IWRS).

Percentage of participants who achieved response on depressive symptoms scale based on MADRS total score at Day 43 were reported. Responders were defined as participants with a \>=50 percent (%) improvement in the MADRS total score from baseline to a given timepoint. The MADRS was a clinician-rated scale designed to measure depression severity and detected changes due to antidepressant treatment. The scale consisted of 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts), each of which was scored from 0 (item not present or normal) to 6 (severe or continuous presence of symptoms). MADRS total score was the sum of scores from individual question items, which ranged from 0 to 60, higher scores represented a more severe condition. Negative change in MADRS total score indicated improvement.

Outcome measures

Outcome measures
Measure	Seltorexant n=105 Participants During DB treatment phase, participants received seltorexant 20 mg tablet orally once daily from Day 1 to Day 42. Participants were then followed up for safety up to 7 to 14 days after end of DB treatment at Day 43 (up to Day 57) during the follow-up phase. Participants who discontinued study drug prior to Day 35 were encouraged to have additional follow-up visits every 2 weeks until Day 50 to 57.	Placebo n=102 Participants During DB treatment phase, participants received placebo matching to seltorexant tablet orally once daily from Day 1 to Day 42. Participants were then followed up for safety up to 7 to 14 days after end of DB treatment at Day 43 (up to Day 57) during the follow-up phase. Participants who discontinued study drug prior to Day 35 were encouraged to have additional follow-up visits every 2 weeks until Day 50 to 57.
Percentage of Participants Who Achieved Response on Depressive Symptoms Scale Based on MADRS Total Score at Day 43	42.9 Percentage of participants	36.3 Percentage of participants

SECONDARY outcome

Timeframe: Baseline (Day 1), Day 43

The PHQ-9 was a 9-item, participant reported outcome measure to assess depressive symptoms. The scale scores each of the 9 symptom domains of the Diagnostic and Statistical Manual of Mental Disorders-5th Edition (DSM-5) major depressive disorder (MDD) criteria. Each item was rated on a 4 point scale (0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day). The participant's item responses were summed to provide a total score (range of 0 to 27), with higher scores indicating greater severity of depressive symptoms. The severity of the PHQ-9 was categorized as follows: none-minimal (0-4), mild (5-9), moderate (10-14), moderately severe (15-19) and severe (20-27). Negative changes in PHQ-9 total score indicated improvement.

Outcome measures

Outcome measures
Measure	Seltorexant n=101 Participants During DB treatment phase, participants received seltorexant 20 mg tablet orally once daily from Day 1 to Day 42. Participants were then followed up for safety up to 7 to 14 days after end of DB treatment at Day 43 (up to Day 57) during the follow-up phase. Participants who discontinued study drug prior to Day 35 were encouraged to have additional follow-up visits every 2 weeks until Day 50 to 57.	Placebo n=89 Participants During DB treatment phase, participants received placebo matching to seltorexant tablet orally once daily from Day 1 to Day 42. Participants were then followed up for safety up to 7 to 14 days after end of DB treatment at Day 43 (up to Day 57) during the follow-up phase. Participants who discontinued study drug prior to Day 35 were encouraged to have additional follow-up visits every 2 weeks until Day 50 to 57.
Change From Baseline to Day 43 in Patient Health Questionnaire, 9-item (PHQ-9) Total Score	-8.8 Units on a scale Standard Deviation 6.44	-8.1 Units on a scale Standard Deviation 6.27

Adverse Events

DB Phase: Seltorexant

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

DB Phase: Placebo

Serious events: 2 serious events

Other events: 11 other events

Deaths: 0 deaths

Follow-up Phase: Seltorexant

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Follow-up Phase: Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	DB Phase: Seltorexant n=107 participants at risk During DB treatment phase, participants received seltorexant 20 mg tablet orally once daily from Day 1 to Day 42.	DB Phase: Placebo n=105 participants at risk During DB treatment phase, participants received placebo matching to seltorexant tablet orally once daily from Day 1 to Day 42.	Follow-up Phase: Seltorexant n=103 participants at risk Participants who received seltorexant 20 mg and completed DB treatment phase entered follow-up phase and were then followed up for safety up to 7 to 14 days after end of DB treatment at Day 43 (up to Day 57). Participants who discontinued study drug prior to Day 35 were encouraged to have additional follow-up visits every 2 weeks until Day 50 to 57.	Follow-up Phase: Placebo n=98 participants at risk Participants who received placebo and completed DB treatment phase entered follow-up phase and were then followed up for safety up to 7 to 14 days after end of DB treatment at Day 43 (up to Day 57). Participants who discontinued study drug prior to Day 35 were encouraged to have additional follow-up visits every 2 weeks until Day 50 to 57.
Psychiatric disorders Depression	0.00% 0/107 • Double-blind (DB) Phase: From Day 1 up to Day 43; Follow up Phase: From Day 44 to Day 57 DB Phase: The safety analysis set included all randomized participants who received at least 1 dose of study intervention in the DB phase. Follow-up Phase: The follow-up analysis set included all randomized participants who entered the follow up phase.	0.95% 1/105 • Double-blind (DB) Phase: From Day 1 up to Day 43; Follow up Phase: From Day 44 to Day 57 DB Phase: The safety analysis set included all randomized participants who received at least 1 dose of study intervention in the DB phase. Follow-up Phase: The follow-up analysis set included all randomized participants who entered the follow up phase.	0.00% 0/103 • Double-blind (DB) Phase: From Day 1 up to Day 43; Follow up Phase: From Day 44 to Day 57 DB Phase: The safety analysis set included all randomized participants who received at least 1 dose of study intervention in the DB phase. Follow-up Phase: The follow-up analysis set included all randomized participants who entered the follow up phase.	0.00% 0/98 • Double-blind (DB) Phase: From Day 1 up to Day 43; Follow up Phase: From Day 44 to Day 57 DB Phase: The safety analysis set included all randomized participants who received at least 1 dose of study intervention in the DB phase. Follow-up Phase: The follow-up analysis set included all randomized participants who entered the follow up phase.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/107 • Double-blind (DB) Phase: From Day 1 up to Day 43; Follow up Phase: From Day 44 to Day 57 DB Phase: The safety analysis set included all randomized participants who received at least 1 dose of study intervention in the DB phase. Follow-up Phase: The follow-up analysis set included all randomized participants who entered the follow up phase.	0.95% 1/105 • Double-blind (DB) Phase: From Day 1 up to Day 43; Follow up Phase: From Day 44 to Day 57 DB Phase: The safety analysis set included all randomized participants who received at least 1 dose of study intervention in the DB phase. Follow-up Phase: The follow-up analysis set included all randomized participants who entered the follow up phase.	0.00% 0/103 • Double-blind (DB) Phase: From Day 1 up to Day 43; Follow up Phase: From Day 44 to Day 57 DB Phase: The safety analysis set included all randomized participants who received at least 1 dose of study intervention in the DB phase. Follow-up Phase: The follow-up analysis set included all randomized participants who entered the follow up phase.	0.00% 0/98 • Double-blind (DB) Phase: From Day 1 up to Day 43; Follow up Phase: From Day 44 to Day 57 DB Phase: The safety analysis set included all randomized participants who received at least 1 dose of study intervention in the DB phase. Follow-up Phase: The follow-up analysis set included all randomized participants who entered the follow up phase.

Other adverse events

Other adverse events
Measure	DB Phase: Seltorexant n=107 participants at risk During DB treatment phase, participants received seltorexant 20 mg tablet orally once daily from Day 1 to Day 42.	DB Phase: Placebo n=105 participants at risk During DB treatment phase, participants received placebo matching to seltorexant tablet orally once daily from Day 1 to Day 42.	Follow-up Phase: Seltorexant n=103 participants at risk Participants who received seltorexant 20 mg and completed DB treatment phase entered follow-up phase and were then followed up for safety up to 7 to 14 days after end of DB treatment at Day 43 (up to Day 57). Participants who discontinued study drug prior to Day 35 were encouraged to have additional follow-up visits every 2 weeks until Day 50 to 57.	Follow-up Phase: Placebo n=98 participants at risk Participants who received placebo and completed DB treatment phase entered follow-up phase and were then followed up for safety up to 7 to 14 days after end of DB treatment at Day 43 (up to Day 57). Participants who discontinued study drug prior to Day 35 were encouraged to have additional follow-up visits every 2 weeks until Day 50 to 57.
Nervous system disorders Headache	13.1% 14/107 • Double-blind (DB) Phase: From Day 1 up to Day 43; Follow up Phase: From Day 44 to Day 57 DB Phase: The safety analysis set included all randomized participants who received at least 1 dose of study intervention in the DB phase. Follow-up Phase: The follow-up analysis set included all randomized participants who entered the follow up phase.	10.5% 11/105 • Double-blind (DB) Phase: From Day 1 up to Day 43; Follow up Phase: From Day 44 to Day 57 DB Phase: The safety analysis set included all randomized participants who received at least 1 dose of study intervention in the DB phase. Follow-up Phase: The follow-up analysis set included all randomized participants who entered the follow up phase.	0.00% 0/103 • Double-blind (DB) Phase: From Day 1 up to Day 43; Follow up Phase: From Day 44 to Day 57 DB Phase: The safety analysis set included all randomized participants who received at least 1 dose of study intervention in the DB phase. Follow-up Phase: The follow-up analysis set included all randomized participants who entered the follow up phase.	0.00% 0/98 • Double-blind (DB) Phase: From Day 1 up to Day 43; Follow up Phase: From Day 44 to Day 57 DB Phase: The safety analysis set included all randomized participants who received at least 1 dose of study intervention in the DB phase. Follow-up Phase: The follow-up analysis set included all randomized participants who entered the follow up phase.

Additional Information

Executive Director CDTL Neuro

Janssen Research & Development, LLC

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 delay to allow for filing of a patent application.
Publication restrictions are in place

Restriction type: OTHER