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
Sites (23)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Northwest Clinical Research Center Coordinator of this site? Confirm its status | Bellevue | United States | Unknown status |
| Adams Clinical Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| IMA Clinical Research PC Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Alpine Research Organization Coordinator of this site? Confirm its status | Clinton | United States | Unknown status |
| Adams Clinical 2 Coordinator of this site? Confirm its status | DeSoto | United States | Unknown status |
| Behavioral Research Specialists, LLC Coordinator of this site? Confirm its status | Glendale | United States | Unknown status |
| Velocity Clinical Research Coordinator of this site? Confirm its status | Hallandale | United States | Unknown status |
| M3 Wake Research 1 Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| Wellness Research Center Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Meridian International Research Coordinator of this site? Confirm its status | Miami Gardens | United States | Unknown status |
| Adams Clinical 3 Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Inner Space Research, LLC Coordinator of this site? Confirm its status | Orem | United States | Unknown status |
| Adams Clinical 1 Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| IMA Clinical Research PC 1 Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| M3 Wake Research Coordinator of this site? Confirm its status | Sandy Springs | United States | Unknown status |
| Tekton Research Inc 1 Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Tekton Research Inc. Coordinator of this site? Confirm its status | Suwanee | United States | Unknown status |
| Cenexel 1 Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Inland Psychiatric Medical Group Inc Coordinator of this site? Confirm its status | Temecula | United States | Unknown status |
| Adams Clinical 4 Coordinator of this site? Confirm its status | The Bronx | United States | Unknown status |
| Pacific Clinical Research Medical Group Coordinator of this site? Confirm its status | Upland | United States | Unknown status |
| Sunwise Clinical Research Coordinator of this site? Confirm its status | Walnut Creek | United States | Unknown status |
| Adams Clinical 5 Coordinator of this site? Confirm its status | Watertown | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.