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

Last updated: March 12, 2026
Sponsor: Janssen Research & Development, LLC
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT07258485
42847922MDD3014
42847922MDD3014
  • Ages 18-74
  • All Genders

Study 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 Criteria

Inclusion

Inclusion criteria:

  • Participants must be medically stable, based on investigator review of medicalhistory, vital signs (including blood pressure), and clinical judgment. In cases ofany medical concern, the investigator has the option to perform local 12-leadelectrocardiogram (ECG) or local clinical laboratory testing at screening. Thisdetermination must be recorded in the participant's source documents and initialedby the investigator

  • Meet diagnostic and statistical manual of mental disorders (5th edition) (DSM-5)diagnostic criteria for major depressive disorder (MDD), without psychotic featuresbased upon clinical assessment and confirmed by the structured clinical interviewfor DSM-5 axis I disorders-clinical trials version (SCID-CT). Must be diagnosed withfirst depressive episode prior to age 60

  • Have had an inadequate response to at least 1 but no more than 2 antidepressants,administered at an adequate dose and duration started in the current episode ofdepression. The current antidepressant cannot be the first antidepressant treatmentfor the first lifetime episode of depression. An inadequate response is defined asless than (<) 50 percent (%) reduction but with some improvement (that is,improvement greater than [>] 0%) in depressive symptom severity with residualsymptoms present, and overall good tolerability, as assessed by the massachusettsgeneral hospital-antidepressant treatment response questionnaire (MGH-ATRQ). Anadequate trial is defined as an antidepressant treatment for at least 6 weeks on astable dose at or above the minimum therapeutic dose specified in the MGH-ATRQ, andthis must include the participant's current antidepressant treatment

  • Is receiving and tolerating well any one of the following selective serotoninreuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI) fordepressive symptoms at screening, in any formulation and approved by the Food andDrug Administration (FDA): citalopram, duloxetine, escitalopram, fluvoxamine,fluoxetine, milnacipran, levomilnacipran, paroxetine, sertraline, venlafaxine,desvenlafaxine, vilazodone, or vortioxetine at a stable dose (at therapeutic doselevel per MGH-ATRQ) for at least 6 weeks

  • Has a body mass index (BMI) of 18 to 40 kilograms per meter square (Kg/m^2),inclusive

Exclusion

Exclusion criteria:

  • Had major surgery (for example, requiring general anesthesia) within 2 weeks beforescreening, or will not have fully recovered from surgery, or has surgery plannedduring the time the participant is expected to participate in the study

  • Has a history of treatment-resistant MDD, defined as a lack of response to 2 or moreadequate antidepressant treatments in the current episode, as indicated by no orminimal (less than or equal to [<=] 25%) improvement in symptoms when treated withan antidepressant of adequate dose (per MGH-ATRQ) and duration (at least 6 weeks)

  • Has a primary DSM-5 diagnosis of panic disorder, generalized anxiety disorder,social anxiety disorder, or specific phobia which has been the primary focus ofpsychiatric treatment within the past 2 years. These are allowed as secondarydiagnoses if MDD is the primary focus of treatment according to the investigator

  • Has a history or current diagnosis of a psychotic disorder, bipolar disorder,intellectual disability, autism spectrum disorder, borderline personality disorder,or somatoform disorders

  • Has cognitive impairment per investigator judgment that would render the informedconsent invalid or limit the ability of the participant to comply with the studyrequirements. Participant has neurodegenerative disorder (for example, alzheimer'sdisease, vascular dementia, parkinson's disease with clinical evidence of cognitiveimpairment) or evidence of mild cognitive impairment

Study Design

Total Participants: 80
Study Start date:
November 24, 2025
Estimated Completion Date:
April 24, 2026

Connect with a study center

  • Behavioral Research Specialists LLC

    Glendale, California 91206
    United States

    Active - Recruiting

  • Pacific Clinical Research Medical Group

    Upland, California 91786
    United States

    Completed

  • Sunwise Clinical Research

    Walnut Creek, California 94596
    United States

    Active - Recruiting

  • Behavioral Research Specialists LLC

    Glendale 5352423, California 5332921 91206
    United States

    Site Not Available

  • Pacific Clinical Research Medical Group

    Upland 5404915, California 5332921 91786
    United States

    Site Not Available

  • Sunwise Clinical Research

    Walnut Creek 5406990, California 5332921 94596
    United States

    Site Not Available

  • Velocity Clinical Research

    Hallandale, Florida 33009
    United States

    Active - Recruiting

  • Meridian International Research

    Miami Gardens, Florida 33014
    United States

    Active - Recruiting

  • Velocity Clinical Research

    Hallandale 4157898, Florida 4155751 33009
    United States

    Site Not Available

  • Meridian International Research

    Miami Gardens 4164167, Florida 4155751 33014
    United States

    Site Not Available

  • IMA Clinical Research PC

    Chicago, Illinois 60634
    United States

    Active - Recruiting

  • Chicago Research Center

    Chicago 4887398, Illinois 4896861 60634
    United States

    Site Not Available

  • Adams Clinical

    Boston, Massachusetts 02116
    United States

    Active - Recruiting

  • Adams Clinical

    Watertown, Massachusetts 02472
    United States

    Active - Recruiting

  • Adams Clinical

    Boston 4930956, Massachusetts 6254926 02116
    United States

    Site Not Available

  • Adams Clinical

    Watertown 4954611, Massachusetts 6254926 02472
    United States

    Site Not Available

  • Adams Clinical

    New York, New York 10029
    United States

    Active - Recruiting

  • Adams Clinical

    The Bronx, New York 10461
    United States

    Active - Recruiting

  • Adams Clinical

    New York 5128581, New York 5128638 10029
    United States

    Site Not Available

  • Adams Clinical

    The Bronx 5110266, New York 5128638 10461
    United States

    Site Not Available

  • Adams Clinical

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • Adams Clinical

    Philadelphia 4560349, Pennsylvania 6254927 19104
    United States

    Site Not Available

  • Adams Clinical

    DeSoto, Texas 75115
    United States

    Active - Recruiting

  • Adams Clinical

    DeSoto 4685524, Texas 4736286 75115
    United States

    Site Not Available

  • Inner Space Research LLC

    Orem, Utah 84058
    United States

    Active - Recruiting

  • Inner Space Research LLC

    Orem 5779334, Utah 5549030 84058
    United States

    Site Not Available

  • Northwest Clinical Research Center

    Bellevue, Washington 98007
    United States

    Active - Recruiting

  • Northwest Clinical Research Center

    Bellevue 5786882, Washington 5815135 98007
    United States

    Site Not Available

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