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

Phase 1

• Conditions: Major Depressive Disorder; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2021-000567-77-ES
• Lead Sponsor: Janssen-Cilag International NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-11
• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 52

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 <18 years at screening.

Type of Participant and Disease Characteristic
2. Must meet DSM-5 diagnosis of MDD without psychotic features.
3. Has inadequate response to at least 1, but no more than 2 antidepressant treatments during the current major depressive episode including their current antidepressant (SSRI).
4. Has had at least 6 sessions of psychotherapy in this episode prior to randomization.
5. Must have Children's Depression Rating Scale-Revised (CDRS-R) total score =48 at the beginning of screening with no more than a 25% improvement during screening.
6. Must be otherwise healthy on the basis of physical examination, medical history, vital signs, 12-lead ECG, and clinical laboratory tests performed at screening.

Weight
7. Participants weighing between 5th and 95th percentile for age and sex with baseline weight is =30 kg.

For the full list of inclusion criteria, please refer to the protocol.
Are the trial subjects under 18? yes
Number of subjects for this age range: 52
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified