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Brain waves during sleep may reveal Depression-Insomnia link

NCT ID NCT07258485

Knowledge-focused Sponsor: Janssen Research & Development, LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 07, 2026 · Updated 2 times

Summary

This study looks at sleep patterns in 94 adults with major depressive disorder, comparing those with moderate-to-severe insomnia to those with mild or no insomnia. Participants wear a headband at home that records brain activity during sleep and also fill out sleep diaries and questionnaires. The goal is to understand how objective brain measures relate to how people feel about their sleep, not to test a treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

94 people

The number who actually took part.

Started

Nov 2025

Finished

Jun 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study population will include participants with MDD with moderate to severe insomnia symptoms (MDDIS) or MDD with no or mild insomnia symptoms (non-MDDIS).

Ages

18 to 74 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

major depressive disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Depressive disorder, major

Contacts and locations

Locations

  • Adams Clinical

    Boston, Massachusetts, 02116, United States

  • Adams Clinical 1

    Philadelphia, Pennsylvania, 19104, United States

  • Adams Clinical 2

    DeSoto, Texas, 75115, United States

  • Adams Clinical 3

    New York, New York, 10029, United States

  • Adams Clinical 4

    The Bronx, New York, 10461, United States

  • Adams Clinical 5

    Watertown, Massachusetts, 02472, United States

  • Alpine Research Organization

    Clinton, Utah, 84015, United States

  • Behavioral Research Specialists LLC

    Glendale, California, 91206, United States

  • Cenexel 1

    Tampa, Florida, 33613, United States

  • IMA Clinical Research PC

    Chicago, Illinois, 60634, United States

  • IMA Clinical Research PC 1

    Phoenix, Arizona, 85012, United States

  • Inland Psychiatric Medical Group Inc

    Temecula, California, 92591, United States

  • Inner Space Research LLC

    Orem, Utah, 84058, United States

  • M3 Wake Research

    Sandy Springs, Georgia, 30328, United States

  • M3 Wake Research 1

    Las Vegas, Nevada, 89146, United States

  • Meridian International Research

    Miami Gardens, Florida, 33014, United States

  • Northwest Clinical Research Center

    Bellevue, Washington, 98007, United States

  • Pacific Clinical Research Medical Group

    Upland, California, 91786, United States

  • Sunwise Clinical Research

    Walnut Creek, California, 94596, United States

  • Tekton Research Inc 1

    St Louis, Missouri, 63128, United States

  • Tekton Research Inc.

    Suwanee, Georgia, 30024, United States

  • Velocity Clinical Research

    Hallandale, Florida, 33009, United States

  • Wellness Research Center

    Miami, Florida, 33135, United States

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