# A Study of Seltorexant as Adjunctive Therapy to Antidepressants in Adult and Elderly Participants With Major Depressive Disorder With Insomnia Symptoms Who Have Responded Inadequately to Antidepressant and Long-term Safety Extension Treatment With Seltorexant

> **NCT04533529** · PHASE3 · COMPLETED · sponsor: **Janssen Research & Development, LLC** · enrollment: 588 (actual)

## Conditions studied

- Depressive Disorder, Major

## Interventions

- **DRUG:** Seltorexant
- **DRUG:** Placebo

## Key facts

- **NCT ID:** NCT04533529
- **Lead sponsor:** Janssen Research & Development, LLC
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2020-09-16
- **Primary completion:** 2023-04-25
- **Final completion:** 2024-04-30
- **Target enrollment:** 588 (ACTUAL)
- **Last updated:** 2026-05-12


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04533529

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04533529, "A Study of Seltorexant as Adjunctive Therapy to Antidepressants in Adult and Elderly Participants With Major Depressive Disorder With Insomnia Symptoms Who Have Responded Inadequately to Antidepressant and Long-term Safety Extension Treatment With Seltorexant". Retrieved via AI Analytics 2026-07-02 from https://api.ai-analytics.org/clinical/NCT04533529. Licensed CC0.

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