Clinical Trial

A Study to Evaluate Sleep Electroencephalogram (EEG) Features (Brain Activity While Sleeping) in Participants With Major Depressive Disorder (MDD)

Completed
View on ClinicalTrials.gov →
Summary
The purpose of this study is to evaluate sleep in participants with Major Depressive Disorder with moderate to severe insomnia symptoms (MDDIS) or MDD with no or mild insomnia symptoms (non-MDDIS), using an at-home sleep Electroencephalogram (EEG; a device that records brain activity during sleep). The study also aims to examine the association between objective sleep EEG features (measured using devices) and subjective sleep measures (self-reported experiences, such as how a person feels about their sleep) in participants with MDDIS or non-MDDIS.
Protocol Amendment History 6 changes
critical Trial completed 2026-07-07
critical Trial status changed: Recruiting → Active, Not Recruiting 2026-06-06
notable Enrollment increased: 80 -> 94 participants 2026-06-06
notable Primary completion pushed: 2026-04-24 -> 2026-06-04 2026-05-09
notable Trial sites expanded: 14 -> 23 locations 2026-04-14
minor Completion pushed: 2026-04-24 -> 2026-06-04 2026-04-14
Trial Details
NCT Number NCT07258485
Lead Sponsor Janssen Research & Development, LLC
Conditions Depressive Disorder, Major
Enrollment 94 participants
Start Date 2025-11-24
Primary Completion 2026-06-04 (estimated)
Study Completion 2026-06-04 (estimated)
Updated on ClinicalTrials.gov 2026-07-06