Back to search results
NCT07573176

A Study of Seltorexant as Monotherapy in Adults and Elderly Participants With Major Depressive Disorder

Recruiting
PHASE3Ages 18–74InterventionalTreatment
Janssen Research & Development, LLC
~600 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:SeltorexantPlacebo

At a glance

Recruiting sites
39 of 39 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Double Blind (DB) Treatment Phase: Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score in Participants with Major Depressive Disorder with Moderate-to-Severe Insomnia Symptoms (MDDIS)
Measured over Baseline up to Day 43
+10 more outcomes measured

Conditions

Depressive Disorder, Major

Explore related trials

Unipolar Depression

Where it's being run

39 sites across 18 states
California6
New York6
Florida5
Taiwan4
Georgia2
Massachusetts2
Oklahoma2
Brazil2

Study leadership

  • Janssen Research & Development, LLC Clinical Trial · STUDY_DIRECTOR · Janssen Research & Development, LLC

Who to contact

Study Contact
[email protected]
844-434-4210
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Meet diagnostic and statistical manual of mental disorders-5th edition (DSM-5) diagnostic criteria for major depressive disorder (MDD), without psychotic features based upon clinical assessment
Experienced at least one MDD episode prior to their current episode
Current episode of MDD must be a minimum of 2 weeks in duration
Must meet one of the following criteria regarding current medication status.
Body Mass Index (BMI) between 18 and 40 kilograms per square meter (kg/m\^2)
Must be medically stable on the basis of the following performed at screening and double-blind (DB) baseline: physical examination (including a brief neurological examination), vital signs (including blood pressure), and 12-lead electrocardiogram (ECG)

Exclusion

Use of ketamine/esketamine in the current depressive episode (up to 2 doses are allowed prior to screening)
Has treatment-resistant depression (TRD)
Has a primary DSM-5 diagnosis of panic disorder, generalized anxiety disorder, social anxiety disorder, or specific phobia which has been the primary focus of psychiatric treatment within the past 2 years
Current active DSM-5 diagnosis of obsessive-compulsive disorder, posttraumatic stress disorder, anorexia nervosa, bulimia nervosa, or fibromyalgia
Has a history or current diagnosis of a psychotic disorder, bipolar disorder, autism spectrum disorder, borderline personality disorder, or somatoform disorders
Has dementia, any dementing disease, intellectual disability, or neurocognitive disorder
Has a current or recent history of homicidal ideation or serious suicidal ideation within the past 3 months or a history of suicidal behavior within the past 6 months
Has a history of moderate-to-severe substance use disorder including alcohol use disorder according to DSM-5 criteria within 6 months
Has any significant sleep disorder, including but not limited to untreated/uncontrolled conditions
Has known allergies, hypersensitivity, intolerance, or any contraindication to seltorexant or its excipients

What this trial measures

  • Double Blind (DB) Treatment Phase: Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score in Participants with Major Depressive Disorder with Moderate-to-Severe Insomnia Symptoms (MDDIS)Baseline up to Day 43

    The MADRS is a clinician-administered scale designed to measure depression severity and detects changes due to antidepressant treatment. The scale consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 60. Higher scores represent a more severe condition.

  • Open-Label (OL) Treatment Phase: Number of Participants with Adverse Events Including Adverse Event of Special Interests (AESIs)OL Baseline (Day 43) Up to 6 months

    An AE is any untoward medical occurrence in a clinical study participant administered with a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the intervention. The following AESIs are considered in this study: Suicidal thoughts, suicidal ideation, and suicidal behavior; Cataplexy; Sleep paralysis; Complex, sleep-related behaviors/parasomnias; Fall and Motor vehicle accident.

  • OL Treatment Phase: Number of Participants with Vital Signs AbnormalitiesOL Baseline (Day 43) Up to 6 months

    Number of participants with vital signs (blood pressure and pulse/heart rate measurements) abnormalities will be reported.

  • OL Treatment Phase: Number of Participants with Suicidality Assessment using Columbia-Suicide Severity Rating Scale (C-SSRS)OL Baseline (Day 43) Up to 6 months

    The C-SSRS is a low-burden measure of the spectrum of suicidal ideation and behavior that was developed to assess severity and track suicidal events through any treatment. The C-SSRS scale consists of 28 items in 4 sections: suicide behavior, actual attempts, suicidal ideation, and intensity of ideation. Suicidal ideation consists of 5 'yes/no' items: wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods (not plan) without intention to act, active suicidal ideation with some intent to act without specific plan, active suicidal ideation with specific plan and intent.

  • OL Treatment Phase: Number of Participants with Withdrawal Symptoms Assessment Using Physician Withdrawal Checklist (PWC-20)End of Treatment/Early withdrawal to end of the Follow-up visit (up to 14 days)

    Potential withdrawal effects will be assessed by the PWC-20. The PWC-20 is a simple and accurate method used to assess potential withdrawal symptoms following cessation of treatment. The PWC-20 is a reliable and sensitive instrument for the assessment of discontinuation symptoms.

  • OL Treatment Phase: Number of Participants with Abnormalities in Electrocardiogram (ECG)OL Baseline (Day 43) up to 6 months

    Number of participants with abnormalities in ECG will be reported.

  • OL Treatment Phase: Number of Participants Reporting Sexual Functioning using Arizona Sexual Experiences Scale (ASEX)Up to 6 months

    The ASEX is a patient-reported 5-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm. Possible total scores range from 5 to 30, with the higher scores indicating more sexual dysfunction. The scale has shown satisfactory reliability and validity.

  • OL Treatment Phase: Change from Baseline in the Body WeightOL Baseline (Day 43) up to 6 months

    Change from baseline in body weight will be reported.

  • OL Treatment Phase: Change from Baseline in the Body Mass Index (BMI)OL Baseline (Day 43) up to 6 months

    Change from baseline in BMI will be reported.

  • OL Treatment Phase: Change from Baseline in the Waist CircumferenceOL Baseline (Day 43) up to 6 months

    Change from baseline in waist circumference will be reported.

  • OL Treatment Phase: Number of Participants with Abnormalities in Clinical Laboratory ParametersOL Baseline (Day 43) up to 6 months

    Number of participants with laboratory abnormalities related to hematology, serum chemistry will be reported.