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

Completed

Conditions studied: Depressive Disorder, Major

In brief

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.

Key facts

Study ID: NCT07258485
Run by: Janssen Research & Development, LLC
People needed: 94
Starts: 2025-11-24
Expected to finish: 2026-06-04
Last updated by the study team: 2026-07-06

Who can join

Age: 18 and older, up to 74. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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 it is running

IMA Clinical Research PC 1 — 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

Full record on ClinicalTrials.gov

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