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Last Updated: March 29, 2024

CLINICAL TRIALS PROFILE FOR SELTOREXANT


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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.
NCT03494907 ↗ A Study to Evaluate the Effects of Single-dose Seltorexant on Electrocardiogram Intervals in Healthy Adult Participants Completed Janssen Research & Development, LLC Phase 1 The purpose of this study is to assess the effects of single dose seltorexant on QT/QTc intervals and electrocardiogram (ECG) morphology at therapeutic and supratherapeutic exposures in healthy adult participants.
NCT03682380 ↗ A Study of Seltorexant (JNJ-42847922) After Single-Dose Administration in Healthy Participants Completed Minerva Neurosciences Phase 1 The purpose of this study is to compare the rate and extent of absorption (relative bioavailability) of seltorexant Phase 3 test formulation(s) relative to a reference Phase 2b tablet formulation dosed in the evening under fasted and semi-fasted conditions (3 hours after meal); to assess the effect of type and timing of the meal on the rate and extent of absorption of seltorexant Phase 3 tablet formulation (low dose and high dose strength) in healthy male and female participants; and to assess the pharmacokinetic of single-dose administration of low dose and high dose of seltorexant in healthy male and female participants 3 hours after meal.
>Trial ID >Title >Status >Phase >Summary

Clinical Trial Conditions for Seltorexant

Condition Name

Condition Name for
Intervention Trials
Depressive Disorder, Major 7
Healthy 6
Abuse Potential 1
Alzheimer Disease 1
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Condition MeSH

Condition MeSH for
Intervention Trials
Depressive Disorder 7
Depression 7
Depressive Disorder, Major 7
Disease 3
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Clinical Trial Locations for Seltorexant

Trials by Country

Trials by Country for
Location Trials
United States 126
Ukraine 4
Belgium 4
Germany 4
Bulgaria 3
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Trials by US State

Trials by US State for
Location Trials
Florida 9
Ohio 8
New York 7
Illinois 7
Georgia 7
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Clinical Trial Progress for Seltorexant

Clinical Trial Phase

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

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

Sponsor Name

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

Sponsor Type for
Sponsor Trials
Industry 20
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