Depressive Disorder, MajorNCT07258485
A Study to Evaluate Sleep Electroencephalogram (EEG) Features (Brain Activity While Sleeping) in Participants With Major Depressive Disorder (MDD)
An observational study of Depressive Disorder, Major, run by Janssen Research & Development, LLC at 23 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Depressive Disorder, Major
- How many people
- 94 participants
- Where
- 23 sitesUnited States
- Study dates
- 24 Nov 2025to 4 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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).
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Northwest Clinical Research Center
Bellevue, Washington, 98007
Adams Clinical
Boston, Massachusetts, 02116
IMA Clinical Research PC
Chicago, Illinois, 60634
Alpine Research Organization
Clinton, Utah, 84015
Adams Clinical 2
DeSoto, Texas, 75115
Behavioral Research Specialists LLC
Glendale, California, 91206
Velocity Clinical Research
Hallandale, Florida, 33009
M3 Wake Research 1
Las Vegas, Nevada, 89146
Wellness Research Center
Miami, Florida, 33135
Meridian International Research
Miami Gardens, Florida, 33014
Adams Clinical 3
New York, New York, 10029
Inner Space Research LLC
Orem, Utah, 84058
Adams Clinical 1
Philadelphia, Pennsylvania, 19104
IMA Clinical Research PC 1
Phoenix, Arizona, 85012
M3 Wake Research
Sandy Springs, Georgia, 30328
Tekton Research Inc 1
St Louis, Missouri, 63128
Tekton Research Inc.
Suwanee, Georgia, 30024
Cenexel 1
Tampa, Florida, 33613
Inland Psychiatric Medical Group Inc
Temecula, California, 92591
Adams Clinical 4
The Bronx, New York, 10461
Pacific Clinical Research Medical Group
Upland, California, 91786
Sunwise Clinical Research
Walnut Creek, California, 94596
Adams Clinical 5
Watertown, Massachusetts, 02472
About this study
Official title: A Study to Evaluate Sleep Electroencephalogram (EEG) Features in Participants With Major Depressive Disorder (MDD)
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.
- Conditions
- Depressive Disorder, Major
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants With Major Depressive Disorder with Moderate to Severe Insomnia Symptoms (MDDIS) | The MDDIS cohort includes participants with moderate to severe insomnia symptom severity as measured by clinical outcome assessments during the screening phase. | |
| Participants With MDD With No Or Mild Insomnia Symptoms (Non-MDDIS) | The Non-MDDIS cohort includes participants with no or mild insomnia symptoms as measured by clinical outcome assessments during the screening phase. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterization of Objective Sleep Electroencephalogram (EEG) Features in Major Depressive Disorder Participants with Moderate to Severe Insomnia Symptoms (MDDIS) or Non-MDDIS As Assessed by Dreem 3S Headband
Objective sleep EEG features in MDD participants will be assessed using dreem 3S headband. It will be used in this study to capture macro and micro sleep architecture including sleep initiation (latent to persistent sleep, sleep onset latency), sleep maintenance (rapid eye movement [REM] latency, total sleep time, REM percentage, and duration) and arousal features (stage shift index, number of awakenings). It also uses a 3D accelerometer to measure movements, head position, and respiratory rate/trace during sleep.
Measured: Day -7 to Day -1
Characterization of Subjective Sleep Measures in MDD Participants with MDDIS or Non-MDDIS As Assessed by Consensus Sleep Diary (CSD)
Subjective sleep EEG features in MDD participants will be assessed using CSD. Participants will be asked to provide answers to questions to determine their subjective experience of nighttime sleep, daytime napping/dozing, feeling refreshed upon awakening, and the usage of over-the-counter and prescription sleep aids and the Dreem 3S headband by recording their answers in a daily sleep diary (CSD). CSD will be used in this study to capture the parameters including self-reported sleep onset latency, subjective total sleep time, subjective wake after sleep onset, subjective number of nighttime awakenings, subjective quality of sleep, subjective refreshed feeling on waking, self-reported number of naps, self-reported nap time, self-reported sleep aids, self-reported sleep impact while utilizing Dreem 3S headband.
Measured: Day -6 to Day 1
Characterization of Subjective Sleep Measures in MDD Participants with MDDIS or Non-MDDIS As Assessed by the Structured Interview Guide (SIGH-D) Used to Implement the 17 item Hamilton Depression Rating Scale (HRSD17)
Subjective sleep EEG features in MDD participants will be assessed using SIGH-D used to implement HRSD17 scale. The structured interview guide SIGH-D will be used to implement the HRSD17. HRSD17 scale contains 17 items pertaining to symptoms of depression experienced over the past week. The questions cover core symptoms of depression as well as appetite and sleep (3 items). Items are scored on a Likert scale of 0-4 or 0-2 depending on the item with a possible range of 0-54.
Measured: Day -7 to Day -1
Characterization of Subjective Sleep Measures in MDD Participants with MDDIS or Non-MDDIS As Assessed by Patient-Reported Outcomes Measurement Information System-Sleep Disturbance (PROMIS-SD)- 8a Short Forms
Subjective sleep EEG features in MDD participants will be assessed using PROMIS-SD-8a. PROMIS-SD-8a uses all items on the 8a form. The PROMIS-SD instrument assesses self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. This includes perceived difficulties and concerns with getting to sleep or staying asleep, as well as perceptions of the adequacy of and satisfaction with sleep. Sleep Disturbance does not focus on symptoms of specific sleep disorders, nor does it provide subjective estimates of sleep quantities (total amount of sleep, time to fall asleep, amount of wakefulness during sleep).
Measured: Day -7 to Day -1
Characterization of Subjective Sleep Measures in MDD Participants with MDDIS or Non-MDDIS As Assessed by PROMIS-SD- 4a Short Forms
Subjective sleep EEG features in MDD participants will be assessed using PROMIS-SD-4a. PROMIS-SD-4a uses 4 of the 8 items on the 8a form. The PROMIS-SD instrument assesses self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. This includes perceived difficulties and concerns with getting to sleep or staying asleep, as well as perceptions of the adequacy of and satisfaction with sleep. Sleep Disturbance does not focus on symptoms of specific sleep disorders, nor does it provide subjective estimates of sleep quantities (total amount of sleep, time to fall asleep, amount of wakefulness during sleep).
Measured: Day -7 to Day -1
Characterization of Subjective Sleep Measures in MDD Participants with MDDIS or Non-MDDIS As Assessed by PROMIS-SD- 10a Short Forms
Subjective sleep EEG features in MDD participants will be assessed using PROMIS-SD-10a. PROMIS-SD-10a uses all items on both the 8a and 2a forms. The PROMIS-SD instrument assesses self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. This includes perceived difficulties and concerns with getting to sleep or staying asleep, as well as perceptions of the adequacy of and satisfaction with sleep. Sleep Disturbance does not focus on symptoms of specific sleep disorders, nor does it provide subjective estimates of sleep quantities (total amount of sleep, time to fall asleep, amount of wakefulness during sleep).
Measured: Day -7 to Day -1
Characterization of Subjective Sleep Measures in MDD Participants with MDDIS or Non-MDDIS As Assessed by Insomnia Severity Index (ISI)
Subjective sleep EEG features in MDD participants will be assessed using patient and clinician version of ISI. The clinician version of the ISI will be completed by an independent rater. The ISI is a 7-item questionnaire assessing the nature, severity, and impact of insomnia. The dimensions evaluated are: severity of sleep onset, sleep maintenance, early morning awakening problems; sleep dissatisfaction; interference of sleep problem with daytime functioning; noticeability of sleep problems by others; and distress caused by the sleep difficulties. A 5-point Likert scale (0-4) is used to rate each item, yielding a total score ranging from 0 to 28. The total score is interpreted as follows: absence of insomnia (0 7); sub threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).
Measured: Day -7 to Day -1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start24 Nov 2025
- Primary completion4 Jun 2026
- Study completion4 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive Disorder, MajorStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07258485
- Sponsor's protocol ID
- 42847922MDD3014
- Other IDs
- 42847922MDD3014
- Status last verified
- Jul 2026
- First submitted
- 21 Nov 2025
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sharing policy of Johnson \& Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate Sleep Electroencephalogram (EEG) Features in Participants With Major Depressive Disorder (MDD)
- ClinicalTrials.gov ID
- NCT07258485
- Acronym / sponsor ID
- 42847922MDD3014
- Conditions
- Depressive Disorder, Major
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 24 Nov 2025 (actual)
- Primary completion
- 4 Jun 2026 (actual)
- Study completion
- 4 Jun 2026 (actual)
- First posted
- 2 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants With Major Depressive Disorder with Moderate to Severe Insomnia Symptoms (MDDIS) | – | –The MDDIS cohort includes participants with moderate to severe insomnia symptom severity as measured by clinical outcome assessments during the screening phase. |
| Participants With MDD With No Or Mild Insomnia Symptoms (Non-MDDIS) | – | –The Non-MDDIS cohort includes participants with no or mild insomnia symptoms as measured by clinical outcome assessments during the screening phase. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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).
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Characterization of Objective Sleep Electroencephalogram (EEG) Features in Major Depressive Disorder Participants with Moderate to Severe Insomnia Symptoms (MDDIS) or Non-MDDIS As Assessed by Dreem 3S Headband
Time frame: Day -7 to Day -1
Objective sleep EEG features in MDD participants will be assessed using dreem 3S headband. It will be used in this study to capture macro and micro sleep architecture including sleep initiation (latent to persistent sleep, sleep onset latency), sleep maintenance (rapid eye movement [REM] latency, total sleep time, REM percentage, and duration) and arousal features (stage shift index, number of awakenings). It also uses a 3D accelerometer to measure movements, head position, and respiratory rate/trace during sleep.
Characterization of Subjective Sleep Measures in MDD Participants with MDDIS or Non-MDDIS As Assessed by Consensus Sleep Diary (CSD)
Time frame: Day -6 to Day 1
Subjective sleep EEG features in MDD participants will be assessed using CSD. Participants will be asked to provide answers to questions to determine their subjective experience of nighttime sleep, daytime napping/dozing, feeling refreshed upon awakening, and the usage of over-the-counter and prescription sleep aids and the Dreem 3S headband by recording their answers in a daily sleep diary (CSD). CSD will be used in this study to capture the parameters including self-reported sleep onset latency, subjective total sleep time, subjective wake after sleep onset, subjective number of nighttime awakenings, subjective quality of sleep, subjective refreshed feeling on waking, self-reported number of naps, self-reported nap time, self-reported sleep aids, self-reported sleep impact while utilizing Dreem 3S headband.
Characterization of Subjective Sleep Measures in MDD Participants with MDDIS or Non-MDDIS As Assessed by the Structured Interview Guide (SIGH-D) Used to Implement the 17 item Hamilton Depression Rating Scale (HRSD17)
Time frame: Day -7 to Day -1
Subjective sleep EEG features in MDD participants will be assessed using SIGH-D used to implement HRSD17 scale. The structured interview guide SIGH-D will be used to implement the HRSD17. HRSD17 scale contains 17 items pertaining to symptoms of depression experienced over the past week. The questions cover core symptoms of depression as well as appetite and sleep (3 items). Items are scored on a Likert scale of 0-4 or 0-2 depending on the item with a possible range of 0-54.
Characterization of Subjective Sleep Measures in MDD Participants with MDDIS or Non-MDDIS As Assessed by Patient-Reported Outcomes Measurement Information System-Sleep Disturbance (PROMIS-SD)- 8a Short Forms
Time frame: Day -7 to Day -1
Subjective sleep EEG features in MDD participants will be assessed using PROMIS-SD-8a. PROMIS-SD-8a uses all items on the 8a form. The PROMIS-SD instrument assesses self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. This includes perceived difficulties and concerns with getting to sleep or staying asleep, as well as perceptions of the adequacy of and satisfaction with sleep. Sleep Disturbance does not focus on symptoms of specific sleep disorders, nor does it provide subjective estimates of sleep quantities (total amount of sleep, time to fall asleep, amount of wakefulness during sleep).
Characterization of Subjective Sleep Measures in MDD Participants with MDDIS or Non-MDDIS As Assessed by PROMIS-SD- 4a Short Forms
Time frame: Day -7 to Day -1
Subjective sleep EEG features in MDD participants will be assessed using PROMIS-SD-4a. PROMIS-SD-4a uses 4 of the 8 items on the 8a form. The PROMIS-SD instrument assesses self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. This includes perceived difficulties and concerns with getting to sleep or staying asleep, as well as perceptions of the adequacy of and satisfaction with sleep. Sleep Disturbance does not focus on symptoms of specific sleep disorders, nor does it provide subjective estimates of sleep quantities (total amount of sleep, time to fall asleep, amount of wakefulness during sleep).
Characterization of Subjective Sleep Measures in MDD Participants with MDDIS or Non-MDDIS As Assessed by PROMIS-SD- 10a Short Forms
Time frame: Day -7 to Day -1
Subjective sleep EEG features in MDD participants will be assessed using PROMIS-SD-10a. PROMIS-SD-10a uses all items on both the 8a and 2a forms. The PROMIS-SD instrument assesses self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. This includes perceived difficulties and concerns with getting to sleep or staying asleep, as well as perceptions of the adequacy of and satisfaction with sleep. Sleep Disturbance does not focus on symptoms of specific sleep disorders, nor does it provide subjective estimates of sleep quantities (total amount of sleep, time to fall asleep, amount of wakefulness during sleep).
Characterization of Subjective Sleep Measures in MDD Participants with MDDIS or Non-MDDIS As Assessed by Insomnia Severity Index (ISI)
Time frame: Day -7 to Day -1
Subjective sleep EEG features in MDD participants will be assessed using patient and clinician version of ISI. The clinician version of the ISI will be completed by an independent rater. The ISI is a 7-item questionnaire assessing the nature, severity, and impact of insomnia. The dimensions evaluated are: severity of sleep onset, sleep maintenance, early morning awakening problems; sleep dissatisfaction; interference of sleep problem with daytime functioning; noticeability of sleep problems by others; and distress caused by the sleep difficulties. A 5-point Likert scale (0-4) is used to rate each item, yielding a total score ranging from 0 to 28. The total score is interpreted as follows: absence of insomnia (0 7); sub threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: Yes. The data sharing policy of Johnson \& Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depressive Disorder, Major, run by Janssen Research & Development, LLC at 23 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterization of Objective Sleep Electroencephalogram (EEG) Features in Major Depressive Disorder Participants with Moderate to Severe Insomnia Symptoms (MDDIS) or Non-MDDIS As Assessed by Dreem 3S Headband (time frame: Day -7 to Day -1). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.