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Depressive Disorder, MajorPhase 3NCT07573176

A Study of Seltorexant as Monotherapy in Adults and Elderly Participants With Major Depressive Disorder

A Phase 3 study testing Seltorexant in people with Depressive Disorder, Major, run by Janssen Research & Development, LLC at 53 sites in 7 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The main purpose of this study is to assess how well the study drug (JNJ-42847922) works (efficacy) compared with placebo in improving depressive symptoms in participants with major depressive disorder ([MDD], a common mood disorder that causes a lasting feeling of sadness and a loss of interest in everyday… Read more about this study

Who is it for?
Ages 18 to 74 years
Conditions the study is for
Depressive Disorder, Major
What is being tested?
Seltorexant
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
600 participants
Where
53 sitesin 7 countries
Study dates
30 Apr 2026to 3 May 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

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

Who may be able to join

  • 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 SCID-CT diagnosed with first depressive episode prior to age 55
  • Experienced at least one MDD episode prior to their current episode based on clinician-confirmed MDD diagnosis/MDE and documented in source records
  • Current episode of MDD must be a minimum of 8 weeks in duration and maximum of 24 months duration
  • Must meet one of the following criteria regarding current medication status.
  • Can be presenting for a new episode of MDD with no adequate antidepressant treatment started in the current episode; however, must have been treated with an antidepressant medication in a prior episode for a minimum of 6 weeks at a stable dose at or above the minimum therapeutic level.
  • OR
Show all 9Show fewer
  • Have taken up to two antidepressant treatments started in the current episode that were stopped (withdrawn), or will be withdrawn (washed out) due to inadequate response as defined by the Massachusetts general hospital antidepressant treatment response questionnaire (MGH-ATRQ)
  • Body Mass Index (BMI) between 18 and 40 kilograms per square meter (kg/m^2)
  • Must be medically stable on the basis of the following performed at screening and double-blind (DB) baseline: physical examination (including a brief neurological examination), vital signs (including blood pressure), and 12-lead electrocardiogram (ECG)

Who cannot join

  • Use of ketamine/esketamine in the current depressive episode (up to 2 doses are allowed prior to screening)
  • Has treatment-resistant depression (TRD)
  • 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
  • Current active DSM-5 diagnosis of obsessive-compulsive disorder, posttraumatic stress disorder, anorexia nervosa, bulimia nervosa, or fibromyalgia
  • Has a history or current diagnosis of a psychotic disorder, bipolar disorder, autism spectrum disorder, borderline personality disorder, or somatoform disorders
  • Has dementia, any dementing disease, intellectual disability, or neurocognitive disorder
Show all 10Show fewer
  • Has a current or recent history of homicidal ideation or serious suicidal ideation within the past 3 months or a history of suicidal behavior within the past 6 months
  • Has a history of moderate-to-severe substance use disorder including alcohol use disorder according to DSM-5 criteria within 6 months
  • Has any significant sleep disorder, including but not limited to untreated/uncontrolled conditions
  • Has known allergies, hypersensitivity, intolerance, or any contraindication to seltorexant or its excipients

Trial locations and contacts

53 sites in 7 countries. Contact the study team or a site near you to ask about taking part.

Study Contact contact

844-434-4210

Participate-In-This-Study1@its.jnj.com

53 sites in 7 countries

United States39 sites, 39 recruiting

  • Agile Clinical Research Trials, LLC

    Atlanta, Georgia, 30328

    Recruiting

  • Pharmasite Research, Inc.

    Baltimore, Maryland, 21208

    Recruiting

  • Northwest Clinical Research Center

    Bellevue, Washington, 98007

    Recruiting

  • CI Trials

    Bellflower, California, 90706

    Recruiting

  • Adams Clinical Boston

    Boston, Massachusetts, 02116

    Recruiting

  • Integrative Clinical Trials LLC

    Brooklyn, Mississippi, 11229

    Recruiting

  • SPRI Clinical Trials, LLC

    Brooklyn, Mississippi, 11235

    Recruiting

  • SanRo Clinical Research Group LLC WCG Clinical Network

    Bryant, Arkansas, 72022

    Recruiting

  • Magnolia Clinical Research LLC

    Cary, North Carolina, 27511

    Recruiting

  • Chicago Research Center

    Chicago, Illinois, 60634

    Recruiting

  • Patient Priority Clinical Sites LLC

    Cincinnati, Ohio, 45215

    Recruiting

  • Alpine Research Organization

    Clinton, Utah, 84015

    Recruiting

  • Future Search Trials of Dallas

    Dallas, Texas, 75251

    Recruiting

  • UHC Research

    Doral, Florida, 33178

    Recruiting

  • Conrad Clinical Research

    Edmond, Oklahoma, 73013

    Recruiting

  • Behavioral Research Specialists LLC

    Glendale, California, 91206

    Recruiting

  • Reliable Clinical Research

    Hialeah, Florida, 33012

    Recruiting

  • Baylor College of Medicine

    Houston, Texas, 77030

    Recruiting

  • DM Clinical Research

    Houston, Texas, 77081

    Recruiting

  • Vector Clinical Trials

    Las Vegas, Nevada, 89128

    Recruiting

  • K2 Medical Research

    Maitland, Florida, 32751

    Recruiting

  • CenExel Marlton NJ

    Marlton, New Jersey, 08053

    Recruiting

  • Pharmax Research Clinic Inc

    Miami, Florida, 33126

    Recruiting

  • Nuovida Research Center

    Miami, Florida, 33186

    Recruiting

  • Bioscience Research LLC

    Mount Kisco, New York, 10549

    Recruiting

  • Fieve Clinical Research Inc

    New York, New York, 10017

    Recruiting

  • Adams Clinical Harlem

    New York, New York, 10029

    Recruiting

  • Manhattan Behavioral Medicine

    New York, New York, 10036

    Recruiting

  • Excell Research Inc

    Oceanside, California, 92056

    Recruiting

  • Sooner Clinical Research

    Oklahoma, Texas, 73116

    Recruiting

  • NRC Research Institute

    Orange, California, 92868

    Recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

    Recruiting

  • Cenexel

    Riverside, California, 92506

    Recruiting

  • Accelerated Clinical Research Group LLC

    Snellville, Georgia, 30078

    Recruiting

  • R and H Clinical Research

    Stafford, Texas, 77494

    Recruiting

  • IPTB Clinical Research

    Tampa, Florida, 33629

    Recruiting

  • Sunwise Clinical Research

    Walnut Creek, California, 94596

    Recruiting

  • Adams Clinical Watertown

    Watertown, Massachusetts, 02472

    Recruiting

  • Health Synergy Clinical Research

    West Palm Beach, Florida, 33407

    Recruiting

Other trials in United States

Taiwan4 sites, 4 recruiting

  • Chung Shan Medical University Hospital

    Taichung, 402

    Recruiting

  • Taipei Mackay Memorial Hospital

    Taipei, 10449

    Recruiting

  • Taipei Medical University Hospital

    Taipei, 110

    Recruiting

  • Taipei Veterans General Hospital

    Taipei, 112

    Recruiting

Other trials in Taiwan

Brazil3 sites, 3 recruiting

  • Instituto Apice

    Salvador, 40170 108

    Recruiting

  • Centro Integrado Facili

    São Bernardo do Campo, 09726 150

    Recruiting

  • BR Trials

    São Paulo, 01236030

    Recruiting

Other trials in Brazil

Argentina2 sites, 2 recruiting

  • Iternova Consultorios en Salud Mental

    Córdoba, X5021

    Recruiting

  • Resolution

    Mendoza, M5502AHV

    Recruiting

Other trials in Argentina

Canada2 sites, 2 recruiting

  • Providence Care Hospital

    Kingston, Ontario, K7L 4X3

    Recruiting

  • Medical Arts Research Health Group

    North Vancouver, British Columbia, V7P2T4

    Recruiting

Other trials in Canada

China2 sites, 2 recruiting

  • Beijing Huilongguan Hospital

    Beijing, 102208

    Recruiting

  • Shanghai Mental Health Center

    Shanghai, 201108

    Recruiting

Other trials in China

Malaysia1 site, 1 recruiting

  • University Malaya Medical Centre

    Kuala Lumpur, 59100

    Recruiting

Other trials in Malaysia

About this study

Official title: A Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate Efficacy and Safety of Seltorexant as Monotherapy in Adult and Elderly Participants With Major Depressive Disorder (MDD) and an Open-label Long-term Extension Treatment With Seltorexant

The main purpose of this study is to assess how well the study drug (JNJ-42847922) works (efficacy) compared with placebo in improving depressive symptoms in participants with major depressive disorder ([MDD], a common mood disorder that causes a lasting feeling of sadness and a loss of interest in everyday activities) in double-blind treatment phase. Further, to evaluate long-term safety and tolerability of JNJ-42847922 in participants with MDD in the open label treatment phase.

Being tested
Seltorexant, Placebo
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.

  • SeltorexantDrug

    Also called JNJ-42847922

    Seltorexant tablet will be administered orally.

  • PlaceboDrug

    Placebo tablet will be administered orally.

Study groups in NCT07573176
Study groupRoleWhat they receive
SeltorexantExperimentalParticipants will receive seltorexant tablet orally once daily, from Day 1 to Day 42 in double blind (DB) treatment phase. Eligible participants who will enter the open label (OL) treatment phase will receive seltorexant tablet daily from OL baseline until the end of phase/ early withdrawal (EW) visit (up to 6 months).
Receives: Drug: Seltorexant
PlaceboPlacebo comparatorParticipants will receive matching placebo tablet orally once daily from Day 1 to Day 42 in double-blind treatment phase. Eligible participants who will enter the OL treatment phase will receive seltorexant tablet daily from OL baseline until the end of phase/ EW visit (up to 6 months).
Receives: Drug: Seltorexant; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Double Blind (DB) Treatment Phase: Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score in Participants with Major Depressive Disorder with Moderate-to-Severe Insomnia Symptoms (MDDIS)

    The MADRS is a clinician-administered scale designed to measure depression severity and detects changes due to antidepressant treatment. The scale consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 60. Higher scores represent a more severe condition.

    Measured: Baseline up to Day 43

  2. Open-Label (OL) Treatment Phase: Number of Participants with Adverse Events Including Adverse Event of Special Interests (AESIs)

    An AE is any untoward medical occurrence in a clinical study participant administered with a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the intervention. The following AESIs are considered in this study: Suicidal thoughts, suicidal ideation, and suicidal behavior; Cataplexy; Sleep paralysis; Complex, sleep-related behaviors/parasomnias; Fall and Motor vehicle accident.

    Measured: OL Baseline (Day 43) Up to 6 months

  3. OL Treatment Phase: Number of Participants with Vital Signs Abnormalities

    Number of participants with vital signs (blood pressure and pulse/heart rate measurements) abnormalities will be reported.

    Measured: OL Baseline (Day 43) Up to 6 months

  4. OL Treatment Phase: Number of Participants with Suicidality Assessment using Columbia-Suicide Severity Rating Scale (C-SSRS)

    The C-SSRS is a low-burden measure of the spectrum of suicidal ideation and behavior that was developed to assess severity and track suicidal events through any treatment. The C-SSRS scale consists of 28 items in 4 sections: suicide behavior, actual attempts, suicidal ideation, and intensity of ideation. Suicidal ideation consists of 5 'yes/no' items: wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods (not plan) without intention to act, active suicidal ideation with some intent to act without specific plan, active suicidal ideation with specific plan and intent.

    Measured: OL Baseline (Day 43) Up to 6 months

  5. OL Treatment Phase: Number of Participants with Withdrawal Symptoms Assessment Using Physician Withdrawal Checklist (PWC-20)

    Potential withdrawal effects will be assessed by the PWC-20. The PWC-20 is a simple and accurate method used to assess potential withdrawal symptoms following cessation of treatment. The PWC-20 is a reliable and sensitive instrument for the assessment of discontinuation symptoms.

    Measured: End of Treatment/Early withdrawal to end of the Follow-up visit (up to 14 days)

  6. OL Treatment Phase: Number of Participants with Abnormalities in Electrocardiogram (ECG)

    Number of participants with abnormalities in ECG will be reported.

    Measured: OL Baseline (Day 43) up to 6 months

  7. OL Treatment Phase: Number of Participants Reporting Sexual Functioning using Arizona Sexual Experiences Scale (ASEX)

    The ASEX is a patient-reported 5-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm. Possible total scores range from 5 to 30, with the higher scores indicating more sexual dysfunction. The scale has shown satisfactory reliability and validity.

    Measured: Up to 6 months

  8. OL Treatment Phase: Change from Baseline in the Body Weight

    Change from baseline in body weight will be reported.

    Measured: OL Baseline (Day 43) up to 6 months

  9. OL Treatment Phase: Change from Baseline in the Body Mass Index (BMI)

    Change from baseline in BMI will be reported.

    Measured: OL Baseline (Day 43) up to 6 months

  10. OL Treatment Phase: Change from Baseline in the Waist Circumference

    Change from baseline in waist circumference will be reported.

    Measured: OL Baseline (Day 43) up to 6 months

  11. OL Treatment Phase: Number of Participants with Abnormalities in Clinical Laboratory Parameters

    Number of participants with laboratory abnormalities related to hematology, serum chemistry will be reported.

    Measured: OL Baseline (Day 43) up to 6 months

Secondary outcomes (12)

  1. DB Treatment Phase: Change from Baseline in MADRS-Without Sleep Item (WOSI) Total Score

    MADRS-WOSI considered 9 of the 10 MADRS items, excluding "reduced sleep" item. The total score ranged from 0 to 54, with higher scores corresponding to greater symptom severity.

    Measured: Baseline up to Day 43

  2. DB Treatment Phase: Change from Baseline in Sleep Disturbance using Patient Reported Outcome Measurement Information System-Sleep Disturbance (PROMIS-SD) Short Form 10a(8a + 2a ) T-score

    The PROMIS-SD is used to assess self-reported perceptions of sleep quality, sleep depth and restoration associated with sleep. The full PROMIS-SD includes 27 items with each item based on a 7-day recall period and assessed on a 5 level Likert-type scale. The 10-item short form will be used, in which responses are scored 1 to 5 for each item. T-score for the PROMIS-SD scales represent the value obtained after using a conversion table to convert the total raw score. To find the total raw score for a short form with all questions answered, sum the values of the response to each question. For example, for the adult 10-item form, the lowest possible raw score is 10; the highest possible raw score is 50. Higher overall score indicates more sleep disturbance.

    Measured: Baseline up to Day 43

  3. DB Treatment phase: Change from Baseline in MADRS-6 Total Score

    The MADRS-6 scale is a clinician-administered questionnaire used to measure the severity of major depressive disorder (MDD) symptoms. The MADRS-6 scale is a subset of the MADRS -10 scale, comprised of the following individual questionnaire items: apparent sadness, reported sadness, inner tension, lassitude, inability to feel, and pessimistic thoughts. Scores range from 0 (no apparent symptoms) to 36 (most severe symptoms).

    Measured: Baseline up to Day 43

  4. DB Treatment Phase: Proportion of Participants with Response on Depressive Symptoms Scale

    Responders are defined as proportion of participants with greater than or equal to (>=) 50 percent (%) improvement in the MADRS total score from baseline to Day 43.

    Measured: Baseline up to Day 43

  5. DB Treatment Phase: Change from Baseline in Sleep Disturbance using PROMIS-SD Short Form 8a T-Score

    The PROMIS-SD is used to assess self-reported perceptions of sleep quality, sleep depth and restoration associated with sleep. The full PROMIS-SD includes 27 items with each item based on a 7-day recall period and assessed on a 5 level Likert-type scale. The 8-item short form will be used in this study, in which responses are scored 1 to 5 for each item. T-score for the PROMIS-SD scales represent the value obtained after using a conversion table to convert the total raw score. To find the total raw score for a short form with all questions answered, sum the values of the response to each question. For example, for the adult 8-item form, the lowest possible raw score is 8; the highest possible raw score is 40. Higher overall score indicates more sleep disturbance.

    Measured: Baseline up to Day 43

  6. DB Treatment Phase: Change from Baseline in Patient Health Questionnaire 9-Item (PHQ-9) Total Score

    The PHQ-9 is a 9-item, participant reported outcome measure to assess depressive symptoms. The scale scores each of the 9 symptom domains of the DSM-5 MDD criteria. Each item is rated on a 4 point scale (0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day). The participant's item responses are summed to provide a total score (range of 0 to 27), with higher scores indicating greater severity of depressive symptoms.

    Measured: Baseline up to Day 43

  7. DB Period: Change from Baseline in Work Productivity and Activity Impairment Questionnaire, Depression (WPAI-D) Scores

    The WPAI-D questionnaire is a patient-reported instrument to measure impairments in both paid work and unpaid work. It measures absenteeism, presenteeism as well as the impairments in unpaid activity because of health problems during the past 7 days. The WPAI yields four types of scores: (a) Absenteeism (work time missed); (b) Presenteeism (impairment at work / reduced on-the-job effectiveness); (c) Work productivity loss (overall work impairment / absenteeism plus presenteeism); (d) Activity Impairment. The first three scores are derived only for respondents who were working (should be missing for non-working), but the last score is applicable for all respondents. Each score ranges from 0 to 100 with higher scores indicating greater impairment and less productivity. Negative changes in score indicates less impairment and greater productivity.

    Measured: Baseline up to Day 43

  8. OL Treatment Phase: Change from Baseline Over Time in MADRS Total Score

    The MADRS is a clinician-administered scale designed to measure depression severity and detects changes due to antidepressant treatment. The scale consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 60. Higher scores represent a more severe condition.

    Measured: OL Baseline (Day 43) up to 6 months

  9. OL Treatment Phase: Change from Baseline Over Time in Clinical Global Impression-Severity (CGI-S) Score

    The CGI-S provides an overall clinician-determined summary measure of the severity of the participant's illness that takes into account all available information, including knowledge of the participant's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the participant's ability to function. The CGI-S evaluates the severity of psychopathology on a scale of 1 to 7. Considering total clinical experience with the depression population, a participant is assessed on severity of illness at the time of rating according to the following criteria: 1=normal (not at all ill); 2=borderline ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients.

    Measured: OL Baseline (Day 43) up to 6 months

  10. OL Treatment Phase: Change from Baseline Over Time in MADRS-WOSI Total Score

    MADRS-WOSI considered 9 of the 10 MADRS items, excluding "reduced sleep" item. The total score ranged from 0 to 54, with higher scores corresponding to greater symptom severity.

    Measured: OL Baseline (Day 43) up to 6 months

  11. OL Treatment Phase: Change from Baseline Over Time in Sleep Disturbance using PROMIS-SD Short Form 10a(8a+2a) T-score

    The PROMIS-SD 10a(8a+2a) is used to assess self-reported perceptions of sleep quality, sleep depth and restoration associated with sleep. The full PROMIS-SD includes 27 items with each item based on a 7-day recall period and assessed on a 5 level Likert-type scale. The 10-item short form will be used, in which responses are scored 1 to 5 for each item. T-score for the PROMIS-SD 10a(8a+2a) scales represent the value obtained after using a conversion table to convert the total raw score. To find the total raw score for a short form with all questions answered, sum the values of the response to each question. For example, for the adult 10-item form, the lowest possible raw score is 10; the highest possible raw score is 50. Higher overall score indicates more sleep disturbance.

    Measured: OL Baseline (Day 43) up to 6 months

  12. OL Treatment Phase: Change from Baseline in Work Productivity and Activity Impairment-Questionnaire Depression (WPAI-D) Score

    The WPAI-D questionnaire is a validated short instrument that assesses impairment in work and other regular activities over the past 7 days. The WPAI yields four types of scores: (a) Absenteeism (work time missed); (b) Presenteeism (impairment at work / reduced on-the-job effectiveness); (c) Work productivity loss (overall work impairment / absenteeism plus presenteeism); (d) Activity Impairment. The first three scores are derived only for respondents who were working (should be missing for non-working), but the last score is applicable for all respondents. Each score ranges from 0 to 100 with higher scores indicating greater impairment and less productivity. Negative changes in score indicates less impairment and greater productivity.

    Measured: OL Baseline (Day 43) up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2026
  2. Study start30 Apr 2026
  3. Primary completion24 Aug 2028 (estimated)
  4. Study completion3 May 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07573176
Sponsor's protocol ID
42847922MDD3011
Status last verified
Nov 2026
First submitted
1 May 2026
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Seltorexant in people with Depressive Disorder, Major, run by Janssen Research & Development, LLC at 53 sites in 7 countries.

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 9 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 sites in United States, Taiwan, Brazil, Argentina, Canada and 2 more countries. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Study Contact (844-434-4210, Participate-In-This-Study1@its.jnj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Double Blind (DB) Treatment Phase: Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score in Participants with Major Depressive Disorder with Moderate-to-Severe Insomnia Symptoms (MDDIS) (time frame: Baseline up to Day 43). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07573176.

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 3 Nov 2026.

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