CLINICAL TRIALS PROFILE FOR SELTOREXANT

Clinical Trials for Seltorexant

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT03227224 ↗	A Study to Evaluate the Efficacy and Safety of JNJ-42847922 as Adjunctive Therapy to Antidepressants in Adult Participants With Major Depressive Disorder Who Have Responded Inadequately to Antidepressant Therapy	Completed	Minerva Neurosciences	Phase 2	The purpose of this study is to assess the dose-response relationship of 2 doses of JNJ-42847922 before interim analysis, and potentially 3 doses based on interim analysis results, compared to placebo as adjunctive therapy to an antidepressant drug in improving depressive symptoms in participants with Major Depressive Disorder (MDD) who have had an inadequate response to current antidepressant therapy with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI); and to assess the safety and tolerability of JNJ-42847922 compared to placebo as adjunctive therapy to an antidepressant in participants with MDD.
NCT03227224 ↗	A Study to Evaluate the Efficacy and Safety of JNJ-42847922 as Adjunctive Therapy to Antidepressants in Adult Participants With Major Depressive Disorder Who Have Responded Inadequately to Antidepressant Therapy	Completed	Janssen Research & Development, LLC	Phase 2	The purpose of this study is to assess the dose-response relationship of 2 doses of JNJ-42847922 before interim analysis, and potentially 3 doses based on interim analysis results, compared to placebo as adjunctive therapy to an antidepressant drug in improving depressive symptoms in participants with Major Depressive Disorder (MDD) who have had an inadequate response to current antidepressant therapy with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI); and to assess the safety and tolerability of JNJ-42847922 compared to placebo as adjunctive therapy to an antidepressant in participants with MDD.
NCT03321526 ↗	A Study to Compare the Efficacy, Safety, and Tolerability of JNJ-42847922 Versus Quetiapine Extended-Release as Adjunctive Therapy to Antidepressants in Adult Participants With Major Depressive Disorder Who Have Responded Inadequately to Antidepress	Completed	Janssen Research & Development, LLC	Phase 2	The purpose of this study is to assess the efficacy of flexibly dosed JNJ-42847922 (20 milligram [mg] or 40 mg) compared to flexibly dosed quetiapine extended-release (XR) (150 mg or 300 mg) as adjunctive therapy to an antidepressant drug in delaying time to all-cause discontinuation of study drug over a 6-months (24 weeks) treatment period, in participants with major depressive disorder (MDD) who have had an inadequate response to current antidepressant therapy with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI).
NCT03375203 ↗	A Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-42847922 in Participants With Insomnia Disorder	Completed	Janssen Research & Development, LLC	Phase 2	The purpose of this 2 month phase 2b study is to investigate the dose response of 3 doses of JNJ-42847922 (Seltorexant) (5,10 and 20 mg) compared to placebo and zolpidem on sleep onset and maintenance and to further document safety and tolerability of JNJ-42847922 (Seltorexant) upon multiple (14 days) dose administration in participants with insomnia disorder.
NCT03438461 ↗	A Study to Evaluate the Relative Oral Bioavailability of Seltorexant (JNJ-42847922) After Administration of 3 Different Formulations in Healthy Participants Under Fasted and Semi-fasted Conditions	Completed	Janssen Research & Development, LLC	Phase 1	The purpose of this study is to assess and compare the pharmacokinetics (PK) and relative oral bioavailability of 3 oral tablet formulations of seltorexant in fasted and semi-fasted conditions.

Clinical Trial Conditions for Seltorexant

Condition Name

Condition Name
Intervention	Trials
Depressive Disorder, Major	7
Healthy	6
Healthy Non-dependent, Recreational Sedative Users	1
Hepatic Impairment	1

Condition MeSH

Condition MeSH
Intervention	Trials
Depressive Disorder, Major	7
Depressive Disorder	7
Depression	7
Disease	3

Clinical Trial Locations for Seltorexant

Trials by Country

Trials by Country
Location	Trials
United States	126
Belgium	4
Germany	4
Ukraine	4
Russian Federation	3

Trials by US State

Trials by US State
Location	Trials
Florida	9
Ohio	8
Texas	7
New York	7
Illinois	7

Clinical Trial Progress for Seltorexant

Clinical Trial Phase

Clinical Trial Phase
Clinical Trial Phase	Trials
Phase 3	3
Phase 2	4
Phase 1	11

Clinical Trial Status

Clinical Trial Status
Clinical Trial Phase	Trials
Completed	8
Recruiting	7
Not yet recruiting	3

Clinical Trial Sponsors for Seltorexant

Sponsor Name

Sponsor Name
Sponsor	Trials
Janssen Research & Development, LLC	18
Minerva Neurosciences	2

Sponsor Type

Sponsor Type
Sponsor	Trials
Industry	20