NCT07573176 · Janssen Research & Development, LLC
A Study of Seltorexant as Monotherapy in Adults and Elderly Participants With Major Depressive Disorder
What this study is about
The main purpose of this study is to assess how well the study drug (JNJ-42847922) works (effectiveness) compared with placebo in improving depressive symptoms in participants with major depressive disorder (\[MDD\], a common mood disorder that causes a lasting feeling of sadness and a loss of interest in everyday activities) in where neither patients nor doctors know which treatment is given treatment phase. Further, to evaluate long-term safety and how well patients handle the treatment of JNJ-42847922 in participants with MDD in the open label treatment phase.
View original scientific description
The main purpose of this study is to assess how well the study drug (JNJ-42847922) works (efficacy) compared with placebo in improving depressive symptoms in participants with major depressive disorder (\[MDD\], a common mood disorder that causes a lasting feeling of sadness and a loss of interest in everyday activities) in double-blind treatment phase. Further, to evaluate long-term safety and tolerability of JNJ-42847922 in participants with MDD in the open label treatment phase.
Interventions
DRUG
Seltorexant
Seltorexant tablet will be administered orally.
DRUG
Placebo
Placebo tablet will be administered orally.
Primary outcome 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)
Time frame: 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)
Time frame: 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 Abnormalities
Time frame: OL 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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 Weight
Time frame: OL 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)
Time frame: 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 Circumference
Time frame: OL 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 Parameters
Time frame: OL Baseline (Day 43) up to 6 months
Number of participants with laboratory abnormalities related to hematology, serum chemistry will be reported.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
- Can be presenting for a new episode of MDD on no antidepressant treatment; however, must have been treated with an antidepressant medication in a prior episode for a minimum of 6 weeks at a stable dose at or above the minimum therapeutic level (medical record/source document). OR
- Have taken up to two antidepressant treatments started in the current episode that were stopped (withdrawn), or will be withdrawn (washed out) due to inadequate response or intolerance.
- 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 criteria
- 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
Where
- Bryant, Arkansas
- Bellflower, California
- Glendale, California
- Oceanside, California
- Orange, California
- Riverside, California
- Walnut Creek, California
- Doral, Florida
- Hialeah, Florida
- Miami, Florida
- Tampa, Florida
- West Palm Beach, Florida
And 16 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 31, 2026 · Source of record for eligibility and locations