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At-home sleep EEG monitoring in adults with major depressive disorder

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

Observational Janssen Research & Development, LLC · NCT07258485

This project will use an at-home sleep EEG to see if brain activity during sleep differs between adults with major depressive disorder who have moderate to severe insomnia and those with little or no insomnia.

Quick facts

Study typeObservational
Enrollment80 (estimated)
Ages18 Years to 74 Years
SexAll
SponsorJanssen Research & Development, LLC Industry-sponsored
Locations23 sites (Phoenix, Arizona and 22 other locations)
Trial IDNCT07258485 on ClinicalTrials.gov

What this trial studies

This observational study enrolls adults diagnosed with major depressive disorder and uses an at-home sleep EEG device to record brain activity during sleep. Participants are classified as having moderate-to-severe insomnia symptoms (MDDIS) or no/mild insomnia (non-MDDIS), and objective EEG features will be compared with participants' self-reported sleep measures. Diagnostic confirmation is by SCID-CT and participants must be medically stable and have had an inadequate response to 1–2 antidepressants in the current episode. Data collection is performed remotely with recordings taken at home and coordination through participating clinical sites in Arizona and California.

Who should consider this trial

Good fit: Ideal candidates are medically stable adults meeting DSM-5 criteria for major depressive disorder (first episode before age 60), able to complete at-home EEG recordings, classified as either moderate-to-severe insomnia or no/mild insomnia, and with an inadequate response to 1–2 antidepressants in the current episode.

Not a fit: Patients without major depressive disorder, those with psychotic features, medically unstable individuals, or people unwilling or unable to complete at-home EEG recordings or attend one of the listed sites are unlikely to benefit from this project.

Why it matters

Potential benefit: If successful, this work could identify sleep EEG patterns that help clinicians tailor treatments for sleep problems in people with depression.

How similar studies have performed: Previous research has shown altered sleep EEG patterns in people with depression, although use of at-home EEG devices for these specific insomnia subgroups is less established.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion criteria:

* Participants must be medically stable, based on investigator review of medical history, vital signs (including blood pressure), and clinical judgment. In cases of any medical concern, the investigator has the option to perform local 12-lead electrocardiogram (ECG) or local clinical laboratory testing at screening. This determination must be recorded in the participant's source documents and initialed by the investigator
* 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:

* Had major surgery (for example, requiring general anesthesia) within 2 weeks before screening, or will not have fully recovered from surgery, or has surgery planned during 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 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

Where this trial is running

Phoenix, Arizona and 22 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Depressive Disorder, Major
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.