Ensayos clínicos
Search for actively enrolling clinical trials
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 and Psychotherapy
Study ID: STU-2022-0681
Summary
This is a 6-week, multicenter, double-blind, randomized, placebo-controlled study to assess the safety, tolerability, and pharmacokinetics of seltorexant in adolescents with MDD who have had an inadequate response to an SSRi and psychotherapy in the current depressive episode. Participants will be randomly assigned (3:1) to a dose of seltorexant or placebo and will be stratified between participants with and without insomnia symptoms. a placebo control will be used to establish the frequency and magnitude of changes in clinical endpoints that may occur in the absence of active intervention. Primary outcome variables are treatment-emergent adverse effects, clinical laboratory values and electrocardiogram, vital signs and physical exam (including weight), suicidality, withdrawal symptoms and menstrual cycle tracking. Secondary outcome variables are changes from baseline to week 6 of depression, global severity of illness, subjective sleep assessment, objective sleep assessment, and cognitive performance.
- Cancer Related
- No
- Healthy Volunteers
- No
- UT Southwestern Principal Investigator
- GRAHAM JOHN EMSLIE
JANSSEN RESEARCH AND DEVELOPMENT LLC
Psychiatric Disorders
objectives: 1. 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 2. To assess the efficacy of seltorexant on symptoms of MDD compared with placebo as adjunctive therapy to an antidepressant 3. To assess the efficacy of seltorexant on symptoms of sleep compared with placebo as adjunctive therapy to an antidepressant 4. To assess the effect of seltorexant as adjunctive therapy to an antidepressant on cognitive performance and sleep related performance Hypothesis: This study is conducted to evaluate the safety and tolerability in the adolescent MDD population. no formal statistical hypothesis testing is planned due to the exploratory and descriptive nature of the study. Rationale: The study is being conducted to provide preliminary safety data and to assess the efficacy of seltorexant (vs. placebo), as adjunctive treatment to a selective serotonin reuptake inhibitor (SSRi) in adolescents (12-17 years inclusive) with MDD, both those with insomnia symptoms and without insomnia symptoms, who have had an inadequate response to treatment with an SSRi over 6 weeks of treatment.
