A study to evaluate the safety and tolerability and to assess blood levels of seltorexant in adolescents with Major Depressive Disorder who have not responded well to their current antidepressant and psychotherapy

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 an SSRI and Psychotherapy

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-000567-77-ES

Enrollment

Registered

2021-06-11

Start date

2021-08-31

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder

Interventions

Product Name: Seltorexant 20mg Film Coated tablets Product Code: JNJ-42847922 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: SELTOREXANT CAS Number: 1452539-75-1 Current Sponsor code: JN

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Each potential participant must satisfy all of the following criteria to be enrolled in the study: Age 1. Male or female, aged 12 to =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Any potential participant who meets any of the following criteria will be excluded from participating in the study: Medical Conditions ? Has current active DSM-5 diagnosis of obsessive-compulsive disorder, post-traumatic stress disorder, anorexia nervosa or bulimia nervosa. A prior history of one or more of these disorders is allowed as long as the disorder(s) have been in remission for at least 6 months. Stable Attention deficit/hyperactive disorder (ADHD/ADD) is allowed. Comorbid anxiety disorders are allowed. ? Has history or current diagnosis of psychotic disorder, bipolar disorder, conduct disorder, intellectual disability, autism spectrum disorder, borderline personality disorder, somatoform disorders, or fibromyalgia. ? Has a significant primary sleep disorder confirmed by PSG assessment at screening for participants in subgroup, 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 a history of moderate to severe substance use disorder including alcohol use disorder according to DSM-5 criteria within 6 months before screening or positive test result(s) for alcohol and/or drugs of abuse. ? Has known allergies, hypersensitivity, or intolerance to seltorexant or its excipients. For the full list of exclusion criteria, please refer to the protocol.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective 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;Secondary Objective: The main secondary objectives are • To assess the efficacy of seltorexant on symptoms of MDD compared with placebo as adjunctive therapy to an antidepressant • To assess the efficacy of seltorexant on symptoms of sleep compared with placebo as adjunctive therapy to an antidepressant • To investigate the pharmacokinetics (PK) of seltorexant as adjunctive therapy to an antidepressant in adolescents with MDD For the full list, please refer to the protocol.;Primary end point(s): 1. TEAEs, adverse events of special interest (AESI), Pediatric Adverse Event Rating Scale (PAERS) 2. Clinical laboratory values and electrocardiogram (ECG) 3. Vital signs and physical examination including weight 4. Suicidality assessment using the Columbia Suicide Severity Rating Scale (C SSRS) 5. Withdrawal symptoms assessment using the Physician Withdrawal Checklist (PWC-20) on stopping study intervention 6. Menstrual cycle tracking;Timepoint(s) of evaluation of this end point: 1. Continuous throughout the study 2 and 6. Screening, baseline and week 6 3 and 4. Screening, baseline, weeks 1, 2, 4, 6 and at follow up 5. Baseline, week 6 and at follow up	—

Measure

Time frame

Main Objective: The primary objective 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;Secondary Objective: The main secondary objectives are • To assess the efficacy of seltorexant on symptoms of MDD compared with placebo as adjunctive therapy to an antidepressant • To assess the efficacy of seltorexant on symptoms of sleep compared with placebo as adjunctive therapy to an antidepressant • To investigate the pharmacokinetics (PK) of seltorexant as adjunctive therapy to an antidepressant in adolescents with MDD For the full list, please refer to the protocol.;Primary end point(s): 1. TEAEs, adverse events of special interest (AESI), Pediatric Adverse Event Rating Scale (PAERS) 2. Clinical laboratory values and electrocardiogram (ECG) 3. Vital signs and physical examination including weight 4. Suicidality assessment using the Columbia Suicide Severity Rating Scale (C SSRS) 5. Withdrawal symptoms assessment using the Physician Withdrawal Checklist (PWC-20) on stopping study intervention 6. Menstrual cycle tracking;Timepoint(s) of evaluation of this end point: 1. Continuous throughout the study 2 and 6. Screening, baseline and week 6 3 and 4. Screening, baseline, weeks 1, 2, 4, 6 and at follow up 5. Baseline, week 6 and at follow up

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Secondary

Measure	Time frame
Secondary end point(s): 1. Change from baseline to Week 6/EOT in the CDRS total score 2. Change from baseline to Week 6 in the MADRS total score 3. Change from baseline over time in the Clinical Global Impression-Severity (CGI S) score 4. Change from baseline to Week 6/EOT on subjective sleep assessment (PROMIS-Pediatric-SD (Short Form 8a)) 5. Change from baseline to Week 6/EOT on objective sleep assessment actigraphy 6. Sparse PK sampling in all participants. Optimal PK sampling in a subgroup of participants For the full list, please refer to the protocol.;Timepoint(s) of evaluation of this end point: 1. Screening, baseline, weeks 1, 2, 4, 6 and at follow up 2 . Baseline, weeks 2 and, 4 and 6 3 and 4. Baseline, weeks 1, 2, 4, 6 and at follow up 5. Continuous throughout the study 6. Week 6	—

Measure

Time frame

Secondary end point(s): 1. Change from baseline to Week 6/EOT in the CDRS total score 2. Change from baseline to Week 6 in the MADRS total score 3. Change from baseline over time in the Clinical Global Impression-Severity (CGI S) score 4. Change from baseline to Week 6/EOT on subjective sleep assessment (PROMIS-Pediatric-SD (Short Form 8a)) 5. Change from baseline to Week 6/EOT on objective sleep assessment actigraphy 6. Sparse PK sampling in all participants. Optimal PK sampling in a subgroup of participants For the full list, please refer to the protocol.;Timepoint(s) of evaluation of this end point: 1. Screening, baseline, weeks 1, 2, 4, 6 and at follow up 2 . Baseline, weeks 2 and, 4 and 6 3 and 4. Baseline, weeks 1, 2, 4, 6 and at follow up 5. Continuous throughout the study 6. Week 6

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Countries

Italy, Spain, Sweden, United Kingdom, United States

Contacts

Public ContactGlobal Clinical Operations

Janssen-Cilag SA

carredon@its.jnj.com34647 350965

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026