Actively Recruiting

Age: 18Years - 74Years
All Genders
NCT07258485

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

Led by Janssen Research & Development, LLC · Updated on 2026-05-08

80

Participants Needed

23

Research Sites

34 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 74Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Medically stable based on medical history, vital signs, and clinical judgment
  • Meet DSM-5 criteria for major depressive disorder without psychotic features, diagnosed before age 60
  • Had inadequate response to 1 or 2 antidepressants during current episode, with some symptom improvement
  • Currently receiving and tolerating a stable dose of an FDA-approved SSRI or SNRI antidepressant for at least 6 weeks
  • Body mass index (BMI) between 18 and 40 kg/m² inclusive
Not Eligible

You will not qualify if you...

  • Major surgery within 2 weeks before screening or planned during study participation
  • History of treatment-resistant MDD, defined as no or minimal improvement after 2 or more adequate antidepressant treatments in current episode
  • Primary diagnosis of panic disorder, generalized anxiety disorder, social anxiety disorder, or specific phobia as main treatment focus within past 2 years
  • History or current diagnosis of psychotic disorder, bipolar disorder, intellectual disability, autism spectrum disorder, borderline personality disorder, or somatoform disorders
  • Cognitive impairment or neurodegenerative disorder that impairs consent or study compliance

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 23 locations

1

IMA Clinical Research PC 1

Phoenix, Arizona, United States, 85012

Actively Recruiting

2

Behavioral Research Specialists LLC

Glendale, California, United States, 91206

Completed

3

Inland Psychiatric Medical Group Inc

Temecula, California, United States, 92591

Actively Recruiting

4

Pacific Clinical Research Medical Group

Upland, California, United States, 91786

Completed

5

Sunwise Clinical Research

Walnut Creek, California, United States, 94596

Actively Recruiting

6

Velocity Clinical Research

Hallandale, Florida, United States, 33009

Actively Recruiting

7

Wellness Research Center

Miami, Florida, United States, 33135

Actively Recruiting

8

Meridian International Research

Miami Gardens, Florida, United States, 33014

Actively Recruiting

9

Cenexel 1

Tampa, Florida, United States, 33613

Actively Recruiting

10

M3 Wake Research

Sandy Springs, Georgia, United States, 30328

Actively Recruiting

11

Tekton Research Inc.

Suwanee, Georgia, United States, 30024

Actively Recruiting

12

IMA Clinical Research PC

Chicago, Illinois, United States, 60634

Actively Recruiting

13

Adams Clinical

Boston, Massachusetts, United States, 02116

Actively Recruiting

14

Adams Clinical 5

Watertown, Massachusetts, United States, 02472

Actively Recruiting

15

Tekton Research Inc 1

St Louis, Missouri, United States, 63128

Actively Recruiting

16

M3 Wake Research 1

Las Vegas, Nevada, United States, 89146

Actively Recruiting

17

Adams Clinical 3

New York, New York, United States, 10029

Actively Recruiting

18

Adams Clinical 4

The Bronx, New York, United States, 10461

Actively Recruiting

19

Adams Clinical 1

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

20

Adams Clinical 2

DeSoto, Texas, United States, 75115

Actively Recruiting

21

Alpine Research Organization

Clinton, Utah, United States, 84015

Actively Recruiting

22

Inner Space Research LLC

Orem, Utah, United States, 84058

Actively Recruiting

23

Northwest Clinical Research Center

Bellevue, Washington, United States, 98007

Actively Recruiting

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Research Team

S

Study Contact

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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