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NCT07258485Completed

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)

Source: ClinicalTrials.gov · Last updated 6 Jul 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
94 (actual)
First submitted
21 Nov 2025
Start date
24 Nov 2025
Primary completion date
4 Jun 2026
Lead sponsor
Janssen Research & Development, LLC
Diseases
Depression
NCT number
NCT07258485

What you commit to

  • Study type: Observational
  • Participants enrolled: 94
  • From 24 Nov 2025 to the primary completion date, 4 Jun 2026
  • 23 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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)

Other illness

  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to 74 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (23)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Northwest Clinical Research Center
Coordinator of this site? Confirm its status
BellevueUnited StatesUnknown status
Adams Clinical
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BostonUnited StatesUnknown status
IMA Clinical Research PC
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ChicagoUnited StatesUnknown status
Alpine Research Organization
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ClintonUnited StatesUnknown status
Adams Clinical 2
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DeSotoUnited StatesUnknown status
Behavioral Research Specialists, LLC
Coordinator of this site? Confirm its status
GlendaleUnited StatesUnknown status
Velocity Clinical Research
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HallandaleUnited StatesUnknown status
M3 Wake Research 1
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Las VegasUnited StatesUnknown status
Wellness Research Center
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MiamiUnited StatesUnknown status
Meridian International Research
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Miami GardensUnited StatesUnknown status
Adams Clinical 3
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New YorkUnited StatesUnknown status
Inner Space Research, LLC
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OremUnited StatesUnknown status
Adams Clinical 1
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PhiladelphiaUnited StatesUnknown status
IMA Clinical Research PC 1
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PhoenixUnited StatesUnknown status
M3 Wake Research
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Sandy SpringsUnited StatesUnknown status
Tekton Research Inc 1
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St LouisUnited StatesUnknown status
Tekton Research Inc.
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SuwaneeUnited StatesUnknown status
Cenexel 1
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TampaUnited StatesUnknown status
Inland Psychiatric Medical Group Inc
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TemeculaUnited StatesUnknown status
Adams Clinical 4
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The BronxUnited StatesUnknown status
Pacific Clinical Research Medical Group
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UplandUnited StatesUnknown status
Sunwise Clinical Research
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Walnut CreekUnited StatesUnknown status
Adams Clinical 5
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WatertownUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.