RecruitingNCT07258485

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

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

Sponsor

Janssen Research & Development, LLC

Enrollment

80 participants

Start Date

Nov 24, 2025

Study Type

OBSERVATIONAL

Conditions

Depressive Disorder, Major

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.

Eligibility

Min Age: 18 YearsMax Age: 74 Years

Plain Language Summary

Simplified for easier understanding

This study uses brain wave monitoring during sleep (sleep EEG) to look for patterns that may help predict how people with major depressive disorder (MDD) respond to antidepressant treatment. Researchers hope this will lead to better, more personalized depression treatment in the future. **You may be eligible if...** - You have been diagnosed with major depressive disorder - You are currently taking an SSRI or SNRI antidepressant (such as fluoxetine, sertraline, venlafaxine, or similar) at a stable dose for at least 6 weeks - Your depression has only partially responded to 1 or 2 antidepressants in the current episode - You are medically stable and between 18 and 65 years old with a BMI of 18–40 **You may NOT be eligible if...** - You have treatment-resistant depression (no response to 2 or more antidepressants) - You have a history of bipolar disorder, psychosis, or certain other psychiatric diagnoses - You have significant cognitive impairment or a neurodegenerative condition - You had major surgery within the last 2 weeks Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(23)

IMA Clinical Research PC

Phoenix, Arizona, United States

Behavioral Research Specialists LLC

Glendale, California, United States

Inland Psychiatric Medical Group Inc

Temecula, California, United States

Pacific Clinical Research Medical Group

Upland, California, United States

Sunwise Clinical Research

Walnut Creek, California, United States

Velocity Clinical Research

Hallandale, Florida, United States

Wellness Research Center

Miami, Florida, United States

Meridian International Research

Miami Gardens, Florida, United States

Cenexel 1

Tampa, Florida, United States

M3 Wake Research

Sandy Springs, Georgia, United States

Tekton Research Inc.

Suwanee, Georgia, United States

IMA Clinical Research PC

Chicago, Illinois, United States

Adams Clinical

Boston, Massachusetts, United States

Adams Clinical 5

Watertown, Massachusetts, United States

Tekton Research Inc 1

St Louis, Missouri, United States

M3 Wake Research 1

Las Vegas, Nevada, United States

Adams Clinical 3

New York, New York, United States

Adams Clinical 4

The Bronx, New York, United States

Adams Clinical 1

Philadelphia, Pennsylvania, United States

Adams Clinical 2

DeSoto, Texas, United States

Alpine Research Organization

Clinton, Utah, United States

Inner Space Research LLC

Orem, Utah, United States

Northwest Clinical Research Center

Bellevue, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT07258485

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