drugset / Trial / NCT04513912
A Study of Seltorexant Compared to Quetiapine XR as Adjunctive Therapy to Antidepressants in Adult and Elderly Participants With Major Depressive Disorder With Insomnia Symptoms Who Have Responded Inadequately to Antidepressant Therapy
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of this study is to assess the efficacy of seltorexant compared with quetiapine extended-release (XR) as adjunctive therapy to an antidepressant drug in treatment response in participants with major depressive disorder with insomnia symptoms (MDDIS) who have had an inadequate response to current antidepressant therapy with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI).
Timeline
- Start
- 2020-09-15
- Primary completion
- 2023-10-03
- Completion
- 2023-10-03
Outcome
Missed primary endpoint
release “Although the study did not meet its primary endpoint, seltorexant showed efficacy comparable to quetiapine XR, a medication with proven efficacy for MDD” jnj.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Quetiapine | Small molecule | — | Oral |
| Subject | Seltorexant | Small molecule | 20 mg | Oral |