A Study to Evaluate Sleep Electroencephalogram (EEG) Features (Brain Activity While Sleeping) in Participants With Major Depressive Disorder (MDD)
NCT ID: NCT07258485
Last Updated: 2026-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
80 participants
OBSERVATIONAL
2025-11-24
2026-04-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Participants With Major Depressive Disorder with Moderate to Severe Insomnia Symptoms (MDDIS)
The MDDIS cohort includes participants with moderate to severe insomnia symptom severity as measured by clinical outcome assessments during the screening phase.
No interventions assigned to this group
Participants With MDD With No Or Mild Insomnia Symptoms (Non-MDDIS)
The Non-MDDIS cohort includes participants with no or mild insomnia symptoms as measured by clinical outcome assessments during the screening phase.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Meet diagnostic and statistical manual of mental disorders (5th edition) (DSM-5) diagnostic criteria for major depressive disorder (MDD), without psychotic features based upon clinical assessment and confirmed by the structured clinical interview for DSM-5 axis I disorders-clinical trials version (SCID-CT). Must be diagnosed with first 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 of depression. The current antidepressant cannot be the first antidepressant treatment for the first lifetime episode of depression. An inadequate response is defined as less than (\<) 50 percent (%) reduction but with some improvement (that is, improvement greater than \[\>\] 0%) in depressive symptom severity with residual symptoms present, and overall good tolerability, as assessed by the massachusetts general hospital-antidepressant treatment response questionnaire (MGH-ATRQ). An adequate trial is defined as an antidepressant treatment for at least 6 weeks on a stable dose at or above the minimum therapeutic dose specified in the MGH-ATRQ, and this must include the participant's current antidepressant treatment
* Is receiving and tolerating well any one of the following selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI) for depressive symptoms at screening, in any formulation and approved by the Food and Drug Administration (FDA): citalopram, duloxetine, escitalopram, fluvoxamine, fluoxetine, milnacipran, levomilnacipran, paroxetine, sertraline, venlafaxine, desvenlafaxine, vilazodone, or vortioxetine at a stable dose (at therapeutic dose level 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 Criteria
* Has a history of treatment-resistant MDD, defined as a lack of response to 2 or more adequate antidepressant treatments in the current episode, as indicated by no or minimal (less than or equal to \[\<=\] 25%) improvement in symptoms when treated with an 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 of psychiatric treatment within the past 2 years. These are allowed as secondary diagnoses 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 informed consent invalid or limit the ability of the participant to comply with the study requirements. Participant has neurodegenerative disorder (for example, alzheimer's disease, vascular dementia, parkinson's disease with clinical evidence of cognitive impairment) or evidence of mild cognitive impairment
18 Years
74 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Locations
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Behavioral Research Specialists LLC
Glendale, 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
Meridian International Research
Miami Gardens, Florida, United States
Chicago Research Center
Chicago, Illinois, United States
Adams Clinical
Boston, Massachusetts, United States
Adams Clinical
Watertown, Massachusetts, United States
Adams Clinical
New York, New York, United States
Adams Clinical
The Bronx, New York, United States
Adams Clinical
DeSoto, Texas, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
Countries
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Central Contacts
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Other Identifiers
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42847922MDD3014
Identifier Type: OTHER
Identifier Source: secondary_id
42847922MDD3014
Identifier Type: -
Identifier Source: org_study_id
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