Depressive Disorder, MajorPhase 1NCT04951609
A Study of Seltorexant as Adjunctive Therapy to Antidepressants in Adolescents With Major Depressive Disorder Who Have an Inadequate Response to Selective Serotonin Reuptake Inhibitor (SSRI) and Psychotherapy
A Phase 1 study testing Seltorexant in people with Depressive Disorder, Major, run by Janssen Research & Development, LLC at 23 sites in 4 countries.
Trial summary
The purpose of this study is to assess the safety and tolerability of Seltorexant as adjunctive therapy to an antidepressant in adolescents with major depressive disorder (MDD) in the short-term compared with placebo. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Depressive Disorder, Major
- What is being tested?
- Seltorexant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 23 sitesin 4 countries
- Study dates
- 2 Sep 2021to 8 Apr 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Has inadequate response to trial of at least 1, but no more than 2 antidepressant treatments during the current major depressive episode including their current antidepressant fluoxetine or escitalopram (SSRI). Inadequate response is determined as less than (<) 50 percentage (%) symptom reduction after adequate antidepressant treatment for at least 6 weeks at or above the minimum therapeutic dose prior to screening
- Has had access to adequate psychotherapy in the current depressive episode (based on investigator judgement/local guidance) prior to randomization
- Must have Children's Depression Rating Scale-Revised (CDRS-R) total score greater than or equal to (>=) 48 at screening and >=40 at the baseline visit
- Participants weighing between fifth and ninety-fifth percentile for age and sex. Obese participants greater than ninety-fifth percentile and underweight participants below fifth percentile may participate following medical clearance, as long as their baseline weight is >=30 kilograms (kg)
- A female participant of childbearing potential must have a negative urine pregnancy test at screening and baseline
Who cannot join
- Has a history of liver or renal insufficiency, significant cardiac (example, congenital heart disease, cardiomyopathy, or tachyarrhythmias), vascular, pulmonary, gastrointestinal, endocrine (including uncontrolled hyperthyroidism), neurologic (including seizure disorder), hematologic, rheumatologic, psychiatric, or metabolic disturbances. Stable medical conditions are allowed
- Has current the diagnostic and statistical manual of mental disorders, fifth edition (DSM-5) diagnosis of conduct disorder, intellectual disability, autism spectrum disorder, borderline personality disorder, somatoform disorders, or fibromyalgia. A prior history of one or more of these disorders is allowed as long as the disorder(s) are currently stable and major depressive disorder (MDD) is not secondary to the original diagnosis. Has a current or prior DSM-5 diagnosis of a psychotic disorder, or bipolar disorder
- Has a significant primary sleep disorder (example, obstructive sleep apnea, parasomnias) at screening but participants with insomnia or hypersomnia disorders are allowed
- At significant risk of committing suicide based on history or according to the investigator's experience, or based on active suicidal ideation, intent or plan, item 4 or 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) within the past 3 months or a history of suicidal behavior within the last 6 months
- Has known allergies, hypersensitivity, or intolerance to seltorexant or its excipients
Trial locations and contacts
23 sites in 4 countries.
23 sites in 4 countries
United States12 sites
Advanced Research Center Inc
Anaheim, California, 92805
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219
University of Texas Southwestern Medical Center
Dallas, Texas, 75247
Sarkis Clinical Trials
Gainesville, Florida, 32607
Baber Research Group
Naperville, Illinois, 60563
Vanderbilt University
Nashville, Tennessee, 37212
Yale University
New Haven, Connecticut, 06520
APG Research LLC
Orlando, Florida, 32803
Southwest Autism Research and Resource Center
Phoenix, Arizona, 85006
University of California at San Diego
San Diego, California, 92103-8620
Family Psychiatry of The Woodlands
The Woodlands, Texas, 77381
CincyScience
West Chester, Ohio, 45069
Spain6 sites
Hosp. Sant Joan de Deu
Esplugues de Llobregat, 08950
Hosp. Gral. Univ. Gregorio Maranon
Madrid, 28007
Clinica Univ. de Navarra Madrid
Madrid, 28027
Hosp. Univ. Ramon Y Cajal
Madrid, 28034
Hosp. Univ. Pta. de Hierro Majadahonda
Majadahonda, 28222
Corporacio Sanitari Parc Tauli
Sabadell, 08208
Italy3 sites
G.Gaslini Institute
Genova, 16147
Ospedale Pediatrico Bambin Gesù
Roma, 00165
Universita Cattolica del Sacro Cuore - Fondazione Policlinico Universitario 'A. Gemelli'
Roma, 00168
United Kingdom2 sites
South London and Maudsley NHS Foundation Trust of The Maudsley Hospital
London, SE5 8AZ
Warneford Hospital, NIHR Clinical Research Facility
Oxford, OX7 3JX
About this study
Official title: A Short-term Exploratory Study to Evaluate Safety, Tolerability and Pharmacokinetics of Seltorexant as Adjunctive Therapy to Antidepressants in Adolescents With Major Depressive Disorder Who Have an Inadequate Response to SSRI Monotherapy and Psychotherapy
The purpose of this study is to assess the safety and tolerability of Seltorexant as adjunctive therapy to an antidepressant in adolescents with major depressive disorder (MDD) in the short-term compared with placebo.
Read the detailed description
The prevalence of major depression is approximately 4 percentage (%) to 8% in adolescents, with the highest incidence of MDD in child onset depression occurring during mid- to late adolescence (that is, 14 to 18 years of age). Seltorexant (JNJ-42847922) is a potent and selective antagonist of the human orexin-2 receptor (OX2R) that is being developed for the treatment of adjunctive treatment of MDD with insomnia symptoms (MDDIS).The study will be conducted in 3 phases: a screening phase (up to 30 days prior to first dose administration), a double-blind (DB) treatment phase (6 weeks), and a follow-up phase (up to 2 weeks including a telephone consult and on-site follow-up visit. The total study duration for each participant will be up to 12 weeks. Efficacy, safety, pharmacokinetics, and biomarkers will be assessed at specified time points during this study. The hypothesis for this study is that the safety, tolerability, and pharmacokinetics in the adolescent MDD population. There is no formal statistical hypothesis testing due to the exploratory and descriptive nature of this study.
- Conditions
- Depressive Disorder, Major
- Being tested
- Seltorexant, Placebo
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SeltorexantDrug
Also called JNJ-42827922
Participants will receive a single oral dose of seltorexant.
PlaceboDrug
Participants will receive matching placebo orally.
| Study group | Role | What they receive |
|---|---|---|
| Seltorexant | Experimental | Participants will receive weight based dose of Seltorexant orally once daily from Day 1 to Day 42 (until the end of Week 6). Participants will continue baseline selective serotonin reuptake inhibitor (SSRI) antidepressant (Fluoxetine or escitalopram) orally once daily. Receives: Drug: Seltorexant |
| Placebo | Placebo comparator | Participants will receive matching placebo tablets to seltorexant orally once daily from Day 1 to Day 42 (until the end of Week 6). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs are adverse events with onset during the double-blind treatment phase or that are a consequence of a preexisting condition that has worsened since baseline.
Measured: Up to 12 weeks
Number of Participants with Adverse Event of Special Interest (AESIs)
Number of participants with AESIs will be reported. AEs are considered to be of special interest in this study: a) Cataplexy (sudden, transient episode of muscle weakness accompanied by conscious awareness); b) Sleep paralysis (the experience of not being able to move, react, or speak when falling asleep/awakening); c) Complex, sleep-related behaviors/parasomnias such as confusional arousals, somnambulism (sleep walking), sleep terrors, bruxism (teeth grinding), sleep sex, sleep-related eating disorder, and catathrenia (REM-associated end-inspiratory apnea/breath holding); d) Any new suicidal behavior or suicidal ideation.
Measured: Up to 12 weeks
Pediatric Adverse Event Rating Scale (PAERS)
The PAERS is a patient-rated scale designed to assess adverse events occurring in pediatric participants treated with psychotropic medication in clinical studies. Individual PAERS (patient-reported version) will rate symptoms and severity of symptoms. This scale has a total of 48 items. There is no overall score and individual item will be rated on a scale of 0 to 4 in which 0 indicates 'not present' and 4 indicates 'very bothersome/an extreme problem'.
Measured: Up to 12 weeks
Number of Participants with Abnormalities in Clinical Laboratory Values
Number of participants with abnormalities in clinical laboratory values (hematology, serum chemistry and urinalysis) will be reported.
Measured: Up to 6 weeks
Number of Participants with Abnormalities in Electrocardiogram (ECG)
Number of participants with abnormalities in ECG will be reported.
Measured: up to 6 weeks
Number of Participants with Abnormalities in Vital Signs
Number of participants with abnormalities in vital sign(blood pressure and pulse/heart rate) will be reported.
Measured: Up to 12 weeks
Number of Participants with Abnormalities in Physical Examination
Number of participants with abnormalities in physical examination including weight will be reported.
Measured: Up to 6 weeks
Suicidality Assessment Using the Columbia Suicide Severity Rating Scale (C-SSRS) Score
Suicidality assessment using the C-SSRS will be reported. C-SSRS is a clinician rated assessment of suicidal behavior and/ or intent. 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. Worsening of suicidal ideation will be an increase in severity of suicidal ideation from baseline.
Measured: Up to 12 weeks
Withdrawal Symptoms Assessment Using the Physician Withdrawal Checklist (PWC-20)
Withdrawal symptoms assessment using the PWC-20 will be reported. 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. Each individual item score ranges from 0 (not present) to 3 (severe), where higher scores = more affected condition.
Measured: 2 weeks
Number of Participants with Menstrual Cycle Tracking
Number of participants with menstrual cycle tracking will be reported. Menstrual cycles will be tracked during the study in female adolescents or participants who have at least one menses using a participant diary and participant's verbal report.
Measured: Up to 6 weeks
Secondary outcomes (8)
Change from Baseline to Week 6/End of Treatment (EOT) in the Children's Depression Rating Scale (CDRS) Total Score
Change from baseline to week 6/EOT in the CDRS total score will be reported. The CDRS-R is a validated 17-item, clinician-rated instrument that measures the severity of a participant's depressive symptoms. The CDRS-R total score is the sum of the responses to 17 questions. Each question is graded on a 5- or 7-point scale. The highest possible score is 113 (the most severe measure of depression), and the lowest is 17 (not suffering from depression).
Measured: Baseline up to 6 weeks
Change from Baseline to Week 6 in Montgomery Asberg Depression Rating Scale (MADRS) Score
Change from baseline in MADRS score will be reported. The 10-item MADRS is a clinician-administered scale designed to measure depression severity and detects changes due to antidepressant treatment. The test 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 score of 60. Higher score represents a more severe condition.
Measured: Baseline up to 6 weeks
Change from Baseline in Clinical Global Impression- severity (CGI-S) Score Over Time
Change from baseline over time in the CGI-S score will be reported. The CGI-S provides an overall clinician-determined summary measure of the severity of the participant's illness. The CGI-S evaluates the severity of psychopathology on a scale of 1 to 7. Considering total clinical experience with the depression population, a participant is assessed on severity of illness at the time of rating according to: 1=normal (not at all ill); 2=borderline ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill participants.
Measured: Baseline up to 6 weeks
Change from Baseline to Week 6/EOT on Subjective Sleep Assessment (Patient Reported Outcome Measurement Information System-Pediatric-Sleep Disturbance [PROMIS-Pediatric-SD] [Short Form 8a])
Change from baseline to week 6/EOT on subjective sleep assessment (PROMIS-Pediatric-SD [short form 8a]) will be reported. The PROMIS-SD is used to assess self-reported perceptions of sleep quality, sleep depth and restoration associated with sleep. The full PROMIS-SD includes 27 items with each item based on a 7-day recall period and assessed on a 5 level Likert-type scale. The 8-item short form will be used in this study, in which responses are scored 1 to 5 for each item. A higher score on 5 of the 8 items reflects a worse outcome, whereas a higher score on 3 items reflects an improved outcome; therefore, the directionality of the 8 item scores is first synchronized prior to calculation of the total raw score. To find the total raw score for a short form with all questions answered, sum the values of the response to each question. Higher overall score indicates more sleep disturbance.
Measured: Baseline up to 6 weeks
Change from Baseline to Week 6/EOT on Objective Sleep Assessment Actigraphy
Change from baseline to week 6/EOT on objective sleep assessment actigraphy will be reported. The primary purpose of actigraphy in this study is to have an objective measure of sleep parameters prior to treatment to complement the Consensus Sleep Diary (CSD) as well as other sleep-related PROs.
Measured: Baseline up to 6 weeks
Cognitive Performance on a Neurocognitive Battery at Baseline and Week 6/EOT
The cogstate computerized cognitive battery is a validated set of assessments which will be performed to assess verbal learning and memory and evaluate cognitive function. The battery will provide assessment of multiple cognitive domains, including attention, visual learning and memory, and executive function. All measures in the cognitive battery have been validated against traditional neuropsychological tests and are sensitive to the effects of various drugs on cognitive performance, including alcohol and benzodiazepines. The participants completed Cogstate computerized cognitive battery has been used for cognitive assessment in several child and adolescent research trials including attention deficit hyperactivity disorder, and demonstrates good reliability and validity in child and adolescent populations. The ISLT has also been used in adolescent trials, demonstrating sensitivity, reliability and validity.
Measured: Baseline, Week 6
Change in Subjective Sleep Related Impairment (PROMIS-Pediatric- Sleep-Related Impairment [SRI])
Change in subjective sleep related impairment (PROMIS-Pediatric-SRI) will be reported. The PROMIS_SRI is used to assess self reported daytime sleepiness and impact on functioning. . The full PROMIS-SD includes 27 items with each item based on a 7-day recall period and assessed on a 5 level Likert-type scale. The 8-item short form will be used in this study, in which responses are scored 1 to 5 for each item. A higher score on 5 of the 8 items reflects a worse outcome, whereas a higher score on 3 items reflects an improved outcome; therefore, the directionality of the 8 item scores is first synchronized prior to calculation of the total raw score. To find the total raw score for a short form with all questions answered, sum the values of the response to each question. Higher overall score indicates more sleep disturbance.
Measured: Up to 6 weeks
Plasma Concentration of Seltorexant
Plasma concentration of seltorexant will be reported using a validated, specific, and sensitive liquid chromatography/mass spectrometry/mass spectrometry (LC-MS/MS) method.
Measured: Up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2021
- Study start2 Sep 2021
- Primary completion8 Apr 2024
- Study completion8 Apr 2024
Why it stopped: Following discussion on pediatric strategy with HAs, it was determined that we have sufficient data to inform next steps for the seltorexant pediatric program.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive Disorder, MajorStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04951609
- Sponsor's protocol ID
- CR109041
- Other IDs
- 2021-000567-77, 42847922MDD1016
- Status last verified
- Apr 2025
- First submitted
- 30 Jun 2021
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Short-term Exploratory Study to Evaluate Safety, Tolerability and Pharmacokinetics of Seltorexant as Adjunctive Therapy to Antidepressants in Adolescents With Major Depressive Disorder Who Have an Inadequate Response to SSRI Monotherapy and Psychotherapy
- ClinicalTrials.gov ID
- NCT04951609
- Acronym / sponsor ID
- CR109041
- Conditions
- Depressive Disorder, Major
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Following discussion on pediatric strategy with HAs, it was determined that we have sufficient data to inform next steps for the seltorexant pediatric program.
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 2 Sep 2021 (actual)
- Primary completion
- 8 Apr 2024 (actual)
- Study completion
- 8 Apr 2024 (actual)
- First posted
- 7 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the safety and tolerability of Seltorexant as adjunctive therapy to an antidepressant in adolescents with major depressive disorder (MDD) in the short-term compared with placebo.
Detailed description
The prevalence of major depression is approximately 4 percentage (%) to 8% in adolescents, with the highest incidence of MDD in child onset depression occurring during mid- to late adolescence (that is, 14 to 18 years of age). Seltorexant (JNJ-42847922) is a potent and selective antagonist of the human orexin-2 receptor (OX2R) that is being developed for the treatment of adjunctive treatment of MDD with insomnia symptoms (MDDIS).The study will be conducted in 3 phases: a screening phase (up to 30 days prior to first dose administration), a double-blind (DB) treatment phase (6 weeks), and a follow-up phase (up to 2 weeks including a telephone consult and on-site follow-up visit. The total study duration for each participant will be up to 12 weeks. Efficacy, safety, pharmacokinetics, and biomarkers will be assessed at specified time points during this study. The hypothesis for this study is that the safety, tolerability, and pharmacokinetics in the adolescent MDD population. There is no formal statistical hypothesis testing due to the exploratory and descriptive nature of this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Seltorexant | Experimental | Drug: SeltorexantParticipants will receive weight based dose of Seltorexant orally once daily from Day 1 to Day 42 (until the end of Week 6). Participants will continue baseline selective serotonin reuptake inhibitor (SSRI) antidepressant (Fluoxetine or escitalopram) orally once daily. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive matching placebo tablets to seltorexant orally once daily from Day 1 to Day 42 (until the end of Week 6). |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Has inadequate response to trial of at least 1, but no more than 2 antidepressant treatments during the current major depressive episode including their current antidepressant fluoxetine or escitalopram (SSRI). Inadequate response is determined as less than (<) 50 percentage (%) symptom reduction after adequate antidepressant treatment for at least 6 weeks at or above the minimum therapeutic dose prior to screening
- Has had access to adequate psychotherapy in the current depressive episode (based on investigator judgement/local guidance) prior to randomization
- Must have Children's Depression Rating Scale-Revised (CDRS-R) total score greater than or equal to (>=) 48 at screening and >=40 at the baseline visit
- Participants weighing between fifth and ninety-fifth percentile for age and sex. Obese participants greater than ninety-fifth percentile and underweight participants below fifth percentile may participate following medical clearance, as long as their baseline weight is >=30 kilograms (kg)
- A female participant of childbearing potential must have a negative urine pregnancy test at screening and baseline
Key exclusion criteria (5 listed)
- Has a history of liver or renal insufficiency, significant cardiac (example, congenital heart disease, cardiomyopathy, or tachyarrhythmias), vascular, pulmonary, gastrointestinal, endocrine (including uncontrolled hyperthyroidism), neurologic (including seizure disorder), hematologic, rheumatologic, psychiatric, or metabolic disturbances. Stable medical conditions are allowed
- Has current the diagnostic and statistical manual of mental disorders, fifth edition (DSM-5) diagnosis of conduct disorder, intellectual disability, autism spectrum disorder, borderline personality disorder, somatoform disorders, or fibromyalgia. A prior history of one or more of these disorders is allowed as long as the disorder(s) are currently stable and major depressive disorder (MDD) is not secondary to the original diagnosis. Has a current or prior DSM-5 diagnosis of a psychotic disorder, or bipolar disorder
- Has a significant primary sleep disorder (example, obstructive sleep apnea, parasomnias) at screening but participants with insomnia or hypersomnia disorders are allowed
- At significant risk of committing suicide based on history or according to the investigator's experience, or based on active suicidal ideation, intent or plan, item 4 or 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) within the past 3 months or a history of suicidal behavior within the last 6 months
- Has known allergies, hypersensitivity, or intolerance to seltorexant or its excipients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SeltorexantAlso: JNJ-42827922Participants will receive a single oral dose of seltorexant. | Drug | Seltorexant |
| PlaceboParticipants will receive matching placebo orally. | Drug | Placebo |
Primary outcome
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to 12 weeks
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs are adverse events with onset during the double-blind treatment phase or that are a consequence of a preexisting condition that has worsened since baseline.
Number of Participants with Adverse Event of Special Interest (AESIs)
Time frame: Up to 12 weeks
Number of participants with AESIs will be reported. AEs are considered to be of special interest in this study: a) Cataplexy (sudden, transient episode of muscle weakness accompanied by conscious awareness); b) Sleep paralysis (the experience of not being able to move, react, or speak when falling asleep/awakening); c) Complex, sleep-related behaviors/parasomnias such as confusional arousals, somnambulism (sleep walking), sleep terrors, bruxism (teeth grinding), sleep sex, sleep-related eating disorder, and catathrenia (REM-associated end-inspiratory apnea/breath holding); d) Any new suicidal behavior or suicidal ideation.
Pediatric Adverse Event Rating Scale (PAERS)
Time frame: Up to 12 weeks
The PAERS is a patient-rated scale designed to assess adverse events occurring in pediatric participants treated with psychotropic medication in clinical studies. Individual PAERS (patient-reported version) will rate symptoms and severity of symptoms. This scale has a total of 48 items. There is no overall score and individual item will be rated on a scale of 0 to 4 in which 0 indicates 'not present' and 4 indicates 'very bothersome/an extreme problem'.
Number of Participants with Abnormalities in Clinical Laboratory Values
Time frame: Up to 6 weeks
Number of participants with abnormalities in clinical laboratory values (hematology, serum chemistry and urinalysis) will be reported.
Number of Participants with Abnormalities in Electrocardiogram (ECG)
Time frame: up to 6 weeks
Number of participants with abnormalities in ECG will be reported.
Number of Participants with Abnormalities in Vital Signs
Time frame: Up to 12 weeks
Number of participants with abnormalities in vital sign(blood pressure and pulse/heart rate) will be reported.
Number of Participants with Abnormalities in Physical Examination
Time frame: Up to 6 weeks
Number of participants with abnormalities in physical examination including weight will be reported.
Suicidality Assessment Using the Columbia Suicide Severity Rating Scale (C-SSRS) Score
Time frame: Up to 12 weeks
Suicidality assessment using the C-SSRS will be reported. C-SSRS is a clinician rated assessment of suicidal behavior and/ or intent. 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. Worsening of suicidal ideation will be an increase in severity of suicidal ideation from baseline.
Withdrawal Symptoms Assessment Using the Physician Withdrawal Checklist (PWC-20)
Time frame: 2 weeks
Withdrawal symptoms assessment using the PWC-20 will be reported. 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. Each individual item score ranges from 0 (not present) to 3 (severe), where higher scores = more affected condition.
Number of Participants with Menstrual Cycle Tracking
Time frame: Up to 6 weeks
Number of participants with menstrual cycle tracking will be reported. Menstrual cycles will be tracked during the study in female adolescents or participants who have at least one menses using a participant diary and participant's verbal report.
8 secondary outcomes
Change from Baseline to Week 6/End of Treatment (EOT) in the Children's Depression Rating Scale (CDRS) Total Score
Time frame: Baseline up to 6 weeks
Change from Baseline to Week 6 in Montgomery Asberg Depression Rating Scale (MADRS) Score
Time frame: Baseline up to 6 weeks
Change from Baseline in Clinical Global Impression- severity (CGI-S) Score Over Time
Time frame: Baseline up to 6 weeks
Change from Baseline to Week 6/EOT on Subjective Sleep Assessment (Patient Reported Outcome Measurement Information System-Pediatric-Sleep Disturbance [PROMIS-Pediatric-SD] [Short Form 8a])
Time frame: Baseline up to 6 weeks
Change from Baseline to Week 6/EOT on Objective Sleep Assessment Actigraphy
Time frame: Baseline up to 6 weeks
Cognitive Performance on a Neurocognitive Battery at Baseline and Week 6/EOT
Time frame: Baseline, Week 6
Change in Subjective Sleep Related Impairment (PROMIS-Pediatric- Sleep-Related Impairment [SRI])
Time frame: Up to 6 weeks
Plasma Concentration of Seltorexant
Time frame: Up to 6 weeks
Results and safety
The study was stopped early (reason given: Following discussion on pediatric strategy with HAs, it was determined that we have sufficient data to inform next steps for the seltorexant pediatric program.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Individual participant dataSharing planned: Yes. The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
23 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Seltorexant in people with Depressive Disorder, Major, run by Janssen Research & Development, LLC at 23 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States, Spain, Italy, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Following discussion on pediatric strategy with HAs, it was determined that we have sufficient data to inform next steps for the seltorexant pediatric program.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Treatment Emergent Adverse Events (TEAEs) (time frame: Up to 12 weeks). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.