ClinicalTrials.gg
Sign In
RecruitingNCT06559306Updated Nov 3, 2026

Phase 3 Study of Adjunctive Treatment With Seltorexant in Adult and Elderly Participants With Major Depressive Disorder and Insomnia Symptoms

A Phase 3 interventional study of Seltorexant and Placebo in Depressive Disorder, Major, sponsored by Janssen Research & Development, LLC. Recruiting at 205 sites in 16 countries. Open to participants aged 18 Years to 74 Years. Per ClinicalTrials.gov, last updated 2026-11-03.

Sponsored by Janssen Research & Development, LLC (part of Johnson & Johnson) · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2024; still recruiting 2 years 3 months later.
Updated Nov 3, 2026Site recruiting status changedStudy completion movedGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
752
Allocation
Randomized
Ages
18 Years to 74 Years
Sex
All
01

Study summary

The purpose of this study is to know how well seltorexant works, and also to evaluate safety and maintenance effect of seltorexant compared with placebo as an adjunctive therapy to an antidepressant in improving depressive symptoms in participants with major depressive disorder with insomnia symptoms (MDDIS) who have had an inadequate response to current antidepressant therapy with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI).

02

Conditions studied

  • Depressive Disorder, Major
03

In context

Depressive Disorder, Major

3,041 studies on the registry are indexed under Depressive Disorder, Major; 588 are open to participants now.

This study's planned enrollment of 752 is above the median of 79 across 2,530 interventional studies indexed under Depressive Disorder, Major.

Browse Depressive Disorder, Major studies →

Lead sponsor

Janssen Research & Development, LLC is the lead sponsor of 932 studies on the registry; 76 are open to participants now.

Of its 285 completed or terminated interventional studies of FDA-regulated products, 136 (48%) have results posted.

Browse Janssen Research & Development, LLC studies →All Johnson & Johnson studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 74 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Participants in part 1 and direct enrollers to part 2:

  • Meet 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) 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 in the current episode of depression. An inadequate response is defined as less than (\<) 50% reduction but with some improvement (that is, improvement greater than [>] 0%) in depressive symptom severity with residual symptoms other than insomnia present, and overall good tolerability, as assessed by the MGH-ATRQ, and this must include the participant's current antidepressant treatment
  • Is receiving and tolerating well any one of the following SSRI or SNRI for depressive symptoms at screening, in any formulation and available in the participating country: citalopram, duloxetine, escitalopram, fluvoxamine, fluoxetine, milnacipran, levomilnacipran, paroxetine, sertraline, venlafaxine, desvenlafaxine, vilazodone, or vortioxetine at a stable dose (at therapeutic dose level) for at least 6 weeks
  • Having a major depressive episode of at least moderate severity, as assessed with 17-item Hamilton Depression Rating Scale, implemented through the Structured Interview Guide (SIGH-D) in a blinded manner at screening and must not demonstrate a improvement from the beginning to end of screening.

Participants entering after completing part 1:

  • Must have completed Part 1 DB treatment phase
  • Can consistently tolerate study drug (at the end of Part 1), and there is no additional safety risk for the participant if they proceed to Part 2
  • Was able to consistently follow the study procedures in Part 1 as judged by the investigator.
  • Must be medically stable based on clinical laboratory tests

Exclusion criteria

Exclusion Criteria:

  • Has a recent (last 3 months) history of, or current signs and symptoms of, severe renal insufficiency or unstable cardiovascular, respiratory, gastrointestinal, neurologic, hematologic, rheumatologic, immunologic or endocrine disorders and uncontrolled Type 1 or Type 2 diabetes mellitus
  • Has a history of narcolepsy and seizures
  • Has current signs/symptoms of hypothyroidism or hyperthyroidism
  • Participants taking thyroid supplementation for antidepressant purposes
  • Has Cushing's disease, Addison's disease, primary amenorrhea, or other evidence of significant medical disorders of the HPA axis
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
752 participants (estimated)

Study arms

  • Experimental
    Part 1: Seltorexant

    Participants will receive seltorexant orally once daily for 6 weeks during the double-blind (DB) treatment phase in Part 1 of the study. Participants who do not proceed to Part 2 of the study will undergo a post-treatment follow-up phase, after the DB treatment phase in Part 1 and will continue to take their single baseline selective serotonin reuptake inhibitor (SSRI)/serotonin-norepinephrine reuptake inhibitor (SNRI) antidepressant throughout the study.

    Drug: Seltorexant · Drug: Selective Serotonin Reuptake Inhibitor (SSRI)/Serotonin-Norepinephrine Reuptake Inhibitor (SNRI)

  • Placebo comparator
    Part 1: Placebo

    Participants will receive matching placebo orally once daily for 6 weeks during the DB treatment phase in Part 1 of the study. Participants who do not proceed to Part 2 of the study will undergo a post-treatment follow-up phase, after the DB treatment phase in Part 1 and will continue to take their single baseline SSRI/SNRI antidepressant throughout the study.

    Drug: Placebo · Drug: Selective Serotonin Reuptake Inhibitor (SSRI)/Serotonin-Norepinephrine Reuptake Inhibitor (SNRI)

  • Experimental
    Part 2: Open Label (OL) Seltorexant

    All participants who complete Part 1, and who meet eligibility criteria for Part 2, as well as direct entry participants, will enter Part 2 of the study. In Part 2 open-label phases (induction and stabilization) all participants (newly enrolled direct entry participants and Part 1 roll-over participants) will receive seltorexant orally in addition to their background SSRI/SNRI treatment.

    Drug: Seltorexant · Drug: Selective Serotonin Reuptake Inhibitor (SSRI)/Serotonin-Norepinephrine Reuptake Inhibitor (SNRI)

  • Experimental
    Part 2: DB Seltorexant

    All participants who complete Part 1, and who meet eligibility criteria for Part 2, as well as direct entry participants, will enter Part 2 of the study. Participants who achieve a stable response during the open-label phase will receive treatment with seltorexant orally once daily during DB Maintenance Phase in Part 2 of the study. Participants will continue to take their single baseline SSRI/SNRI antidepressant throughout the study.

    Drug: Seltorexant · Drug: Selective Serotonin Reuptake Inhibitor (SSRI)/Serotonin-Norepinephrine Reuptake Inhibitor (SNRI)

  • Placebo comparator
    Part 2: DB Placebo

    All participants who complete Part 1, and who meet eligibility criteria for Part 2, as well as direct entry participants, will enter Part 2 of the study. Participants who achieve a stable response during the open-label phases will receive treatment with matching placebo orally once daily during DB Maintenance Phase in Part 2 of the study. Participants will continue to take their single baseline SSRI/SNRI antidepressant throughout the study.

    Drug: Placebo · Drug: Selective Serotonin Reuptake Inhibitor (SSRI)/Serotonin-Norepinephrine Reuptake Inhibitor (SNRI)

Interventions

  • DrugSeltorexant

    Seltorexant will be administered orally.

    Also known as: JNJ 42847922

  • DrugPlacebo

    Matching Placebo tablets will be administered orally.

  • DrugSelective Serotonin Reuptake Inhibitor (SSRI)/Serotonin-Norepinephrine Reuptake Inhibitor (SNRI)

    SSRI/SNRI will be administered orally.

06

What researchers measure

Primary outcomes

  1. Part 1: Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Day 43

    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.

    Time frame: Baseline, Day 43

  2. Part 2: Time from Randomization to the First Relapse in Participants Who Achieve a Stable Response

    Stable response is defined as a greater than equal to (\>=) 50 percent (%) reduction in the MADRS total score for the last 3 consecutive visits of the OL stabilization Phase, as assessed by the site investigator. Time from randomization to the first relapse during the DB maintenance phase in participants who achieve a stable response at the end of OL seltorexant treatment will be reported.

    Time frame: Time from randomization to the first Relapse during the maintenance phase (up to 2 years and 10 months)

Secondary outcomes

  1. Part 1: Change from Baseline in the MADRS Without Sleep Item (MADRS-WOSI) Total Score at Day 43

    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.

    Time frame: Baseline, Day 43

  2. Part 1: Change from Baseline in Sleep Disturbance Using the Patient Reported Outcome Measurement Information System-Sleep Disturbance (PROMIS-SD) Short Form 8a T-score at Day 43

    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.

    Time frame: Baseline, Day 43

  3. Part 1: Change from Baseline in the MADRS-6 Total Score at Day 43

    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).

    Time frame: Baseline, Day 43

  4. Part 1: Percentage of Participants with Response on Depressive Symptoms Scale Based on Montgomery-Asberg Depression Rating Scale (MADRS) Total score From Baseline to Day 43

    Responders are defined as participants with \>= 50 percent improvement in the MADRS total score from baseline to Day 43.

    Time frame: From Baseline to Day 43

  5. Part 1: Change from Baseline in Sleep Disturbance Using the Patient Reported Outcome Measurement Information System-Sleep Disturbance (PROMIS-SD) Short Form (4a) T-score at Day 43

    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 4-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 4-item form, the lowest possible raw score is 4; the highest possible raw score is 20. Higher overall score indicates more sleep disturbance.

    Time frame: Baseline, Day 43

  6. Part 1: Change from Baseline in Sleep Disturbance Using the Patient Reported Outcome Measurement Information System-Sleep Disturbance (PROMIS-SD) Short Form (10a) T-score at Day 43

    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.

    Time frame: Baseline, Day 43

  7. Part 1: Change from Baseline in Patient Health Questionnaire, 9-Item (PHQ-9) Total Score at Day 43

    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 diagnostic and statistical manual of mental disorders-5th edition (DSM-5) major depressive disorder (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.

    Time frame: Baseline, Day 43

  8. Part 2: Time from Randomization to the First Relapse in Participants Who Achieve a Stable Remission

    Stable remission is defined as MADRS total score less than or equal to (\<=)10 and CGI-S \<= 2 for at least 4 consecutive weeks of the OL stabilization Phase. Time from randomization to the first relapse during the DB maintenance phase in participants who achieve stable remission at the end of the OL seltorexant treatment will be reported.

    Time frame: Time from randomization to the first relapse during the maintenance phase (up to 2 years and 10 months)

  9. Part 2: Change from Baseline to Endpoint of the DB Maintenance Phase in Sleep Disturbance Using the 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.

    Time frame: From Baseline (Day 1 in the DB treatment maintenance Phase) until end point of the DB maintenance phase (that is up to Day 337)

  10. Part 2: Change from Baseline to Endpoint of the DB Maintenance Phase in Sleep Disturbance Using the PROMIS-SD Short Form (4a) 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 4-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 4-item form, the lowest possible raw score is 4; the highest possible raw score is 20. Higher overall score indicates more sleep disturbance.

    Time frame: From Baseline (Day 1 in the DB treatment maintenance Phase) until end point of the DB maintenance phase (that is up to Day 337)

  11. Part 2: Change from Baseline in Sleep Disturbance Using the Patient Reported Outcome Measurement Information System-Sleep Disturbance (PROMIS-SD) Short Form (10a) T-score at Day 43

    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.

    Time frame: Baseline, Day 43

  12. Part 2: Change from Baseline to Endpoint of the DB Maintenance Phase 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.

    Time frame: From Baseline (Day 1 in the DB treatment maintenance Phase) until end point of the DB maintenance phase (that is up to Day 337)

  13. Part 2: Change from Baseline to Endpoint of DB Maintenance Phase in PHQ-9 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.

    Time frame: From Baseline (Day 1 in the DB Treatment Maintenance Phase) Until End Point of the DB Maintenance Phase (that is, up to Day 337)

  14. Change From Baseline to Endpoint of the DB Maintenance Phase in the MADRS-6 score

    The MADRS-6 scale is a clinician-administered questionnaire used to measure the severity of 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).

    Time frame: From Baseline (Day 1 in the DB treatment maintenance Phase) until end point of the DB maintenance phase (that is up to Day 337)

  15. Change from Baseline to Endpoint of the DB Maintenance Phase in the MADRS symptoms other than insomnia MADRS Without Sleep Item (MADRS-WOSI)

    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.

    Time frame: From Baseline (Day 1 in the DB treatment maintenance Phase) until end point of the DB maintenance phase (that is up to Day 337)

07

Study locations

67 of 205 sites recruiting
  • University of Alabama at Birmingham
    Birmingham, Alabama 35294, United States
    Completed

    Not enrolling at this site — choose another above.

  • Chandler Clinical Trials
    Chandler, Arizona 85224, United States
    Completed

    Not enrolling at this site — choose another above.

  • University of Arizona
    Tucson, Arizona 85724, United States
    Recruiting
  • SanRo Clinical Research Group LLC WCG Clinical Network
    Bryant, Arkansas 72022, United States
    Recruiting
  • Preferred Research Partners
    Little Rock, Arkansas 72211, United States
    Completed

    Not enrolling at this site — choose another above.

  • PAMOJA Clinical Institute LLC
    Anaheim, California 92801, United States
    Recruiting
  • Axiom Research
    Colton, California 92324, United States
    Recruiting
  • Elite Research Network 6
    Encino, California 91316, United States
    Completed

    Not enrolling at this site — choose another above.

  • Behavioral Research Specialists LLC
    Glendale, California 91206, United States
    Recruiting
  • WR PRI Los Alamitos
    Los Alamitos, California 90720, United States
    Completed

    Not enrolling at this site — choose another above.

  • Excell Research Inc
    Oceanside, California 92056, United States
    Recruiting
  • Prospective Research Innovations Inc
    Rancho Cucamonga, California 91730, United States
    Completed

    Not enrolling at this site — choose another above.

  • Anderson Clinical Research
    Redlands, California 92374, United States
    Recruiting
  • Lumos Clinical Research Center LLC
    San Jose, California 95124, United States
    Recruiting
  • Syrentis Clinical Research
    Santa Ana, California 92705, United States
    Completed

    Not enrolling at this site — choose another above.

  • California Neuroscience Research
    Sherman Oaks, California 91403, United States
    Completed

    Not enrolling at this site — choose another above.

  • Mountain View Clinical Research
    Denver, Colorado 80209, United States
    Recruiting
  • UConn Health Center
    Farmington, Connecticut 06030, United States
    Recruiting
  • Clinical Research of Brandon
    Brandon, Florida 33511, United States
    Recruiting
  • AGA Clinical Trials
    Hialeah, Florida 33012, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Reliable Clinical Research
    Hialeah, Florida 33012, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Advanced Research Institute of Miami
    Homestead, Florida 33033, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Clinical NeuroScience Solutions Inc
    Jacksonville, Florida 32256, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Multi Specialty Research Associates Inc
    Lake City, Florida 32055, United States
    Completed

    Not enrolling at this site — choose another above.

  • Alcanza Clinical Research
    Largo, Florida 33777, United States
    Completed

    Not enrolling at this site — choose another above.

  • Pharmax Research Clinic Inc
    Miami, Florida 33126, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Miami Dade Medical Research Institute
    Miami, Florida 33176, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Nuovida Research Center
    Miami, Florida 33186, United States
    Recruiting
  • Aqualane Clinical Research
    Naples, Florida 34105, United States
    Completed

    Not enrolling at this site — choose another above.

  • Bravo Health Care Center
    North Bay Village, Florida 33141, United States
    Completed

    Not enrolling at this site — choose another above.

  • Nova Psychiatry INC
    Orlando, Florida 32803, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Florida Center for TMS
    Saint Augustine, Florida 32086, United States
    Completed

    Not enrolling at this site — choose another above.

  • University of South Florida
    Tampa, Florida 33613, United States
    Completed

    Not enrolling at this site — choose another above.

  • Psych Me Medical Research Inc
    Tampa, Florida 33614, United States
    Recruiting
  • Interventional Psychiatry of Tampa Bay
    Tampa, Florida 33629, United States
    Recruiting
  • Health Synergy Clinical Research
    West Palm Beach, Florida 33407, United States
    Recruiting
  • Conquest Research
    Winter Park, Florida 32789, United States
    Completed

    Not enrolling at this site — choose another above.

  • Advanced Discovery Research
    Atlanta, Georgia 30318, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Agile Clinical Research Trials, LLC
    Atlanta, Georgia 30328, United States
    Recruiting
  • iResearch Atlanta LLC
    Decatur, Georgia 30030, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Peachford Hospital-Atlanta Behavorial Research
    Dunwoody, Georgia 30338, United States
    Completed

    Not enrolling at this site — choose another above.

  • iResearch Savannah
    Savannah, Georgia 31405, United States
    Completed

    Not enrolling at this site — choose another above.

  • Accelerated Clinical Research Group LLC
    Snellville, Georgia 30078, United States
    Completed

    Not enrolling at this site — choose another above.

  • Renew Health Clinical Research
    Snellville, Georgia 30078, United States
    Completed

    Not enrolling at this site — choose another above.

  • Northwestern University
    Chicago, Illinois 60611, United States
    Recruiting
  • MetroMed Clinical Research
    Chicago, Illinois 60614, United States
    Completed

    Not enrolling at this site — choose another above.

  • University of Chicago Medical Center
    Chicago, Illinois 60637, United States
    Completed

    Not enrolling at this site — choose another above.

  • Revive Research Institute
    Elgin, Illinois 60123, United States
    Completed

    Not enrolling at this site — choose another above.

  • Baber Research Group
    Naperville, Illinois 60563, United States
    Recruiting
  • Boston Clinical Trials
    Boston, Massachusetts 02131, United States
    Completed

    Not enrolling at this site — choose another above.

  • Adams Clinical LLC
    Watertown, Massachusetts 02472, United States
    Recruiting
  • Mankato Clinic
    Mankato, Minnesota 56001, United States
    Completed

    Not enrolling at this site — choose another above.

  • Redbird Research
    Las Vegas, Nevada 89119, United States
    Completed

    Not enrolling at this site — choose another above.

  • Oasis Clinical Research LLC
    Las Vegas, Nevada 89121, United States
    Completed

    Not enrolling at this site — choose another above.

  • ActivMed Practices and Research
    Portsmouth, New Hampshire 03801, United States
    Completed

    Not enrolling at this site — choose another above.

  • Integrative Clinical Trials LLC
    Brooklyn, New York 11229, United States
    Recruiting
  • SPRI Clinical Trials, LLC
    Brooklyn, New York 11235, United States
    Recruiting
  • University at Buffalo Psychiatry
    Buffalo, New York 14202, United States
    Completed

    Not enrolling at this site — choose another above.

  • Bioscience Research LLC
    Mount Kisco, New York 10549, United States
    Recruiting
  • Fieve Clinical Research Inc
    New York, New York 10017, United States
    Recruiting
  • Hapworth Psychiatric Medical PLLC
    New York, New York 10022, United States
    Completed

    Not enrolling at this site — choose another above.

  • Lucian Miron Manu MD Psychiatry PC
    Woodbury, New York 11797, United States
    Completed

    Not enrolling at this site — choose another above.

  • IMA Clinical Research PC 3
    Hickory, North Carolina 28601, United States
    Completed

    Not enrolling at this site — choose another above.

  • Haidar Almhana Nieding
    Avon Lake, Ohio 44012, United States
    Completed

    Not enrolling at this site — choose another above.

  • Patient Priority Clinical Sites LLC
    Cincinnati, Ohio 45215, United States
    Recruiting
  • University of Cincinnati College of Medicine
    Cincinnati, Ohio 45219, United States
    Completed

    Not enrolling at this site — choose another above.

  • The Ohio State University
    Columbus, Ohio 43210, United States
    Recruiting
  • North Star Medical Research
    Middleburg Heights, Ohio 44130, United States
    Completed

    Not enrolling at this site — choose another above.

  • Conrad Clinical Research
    Edmond, Oklahoma 73013, United States
    Recruiting
  • University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
    Recruiting
  • Clinical Trials of South Carolina
    Charleston, South Carolina 29406, United States
    Recruiting
  • Medical University of South Carolina
    Charleston, South Carolina 29425, United States
    Completed

    Not enrolling at this site — choose another above.

  • The University of Texas at Austin
    Austin, Texas 78712, United States
    Completed

    Not enrolling at this site — choose another above.

  • BioBehavioral Research of Austin PC
    Austin, Texas 78759, United States
    Completed

    Not enrolling at this site — choose another above.

  • Houston Clinical Trials LLC
    Bellaire, Texas 77401, United States
    Recruiting
  • Relaro Medical Trials
    Dallas, Texas 75243, United States
    Completed

    Not enrolling at this site — choose another above.

  • North Texas Clinical Trials
    Fort Worth, Texas 76104, United States
    Recruiting
  • VAST Clinical Research
    Garland, Texas 75041, United States
    Completed

    Not enrolling at this site — choose another above.

  • Baylor College of Medicine
    Houston, Texas 77030, United States
    Recruiting
  • DM Clinical Research
    Houston, Texas 77081, United States
    Completed

    Not enrolling at this site — choose another above.

  • R and H Clinical Research
    Stafford, Texas 77477, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Grayline Research Center
    Wichita Falls, Texas 76309, United States
    Recruiting
  • Cedar Clinical Research
    Draper, Utah 84020, United States
    Completed

    Not enrolling at this site — choose another above.

  • Core Clinical Research
    Everett, Washington 98201, United States
    Recruiting
  • Fundacion para el Estudio y Tratamiento de las Enfermedades Mentales
    Buenos Aires, C1133AAH, Argentina
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • CEN Consultorios Especializados en Neurociencias
    Córdoba, 5000FJF, Argentina
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Instituto Medico DAMIC
    Córdoba, X5003DCE, Argentina
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Centro Medico Luquez
    Córdoba, X5006CBI, Argentina
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Sanatorio Prof Leon S Morra S A
    Córdoba, X5009BIN, Argentina
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • INSA Instituto de Neurociencias San Agustín
    La Plata, 1900, Argentina
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • C I A P Centro de investigacion y Asistencia en Psiquiatria
    Rosario, 2000, Argentina
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Clinica El Jardin
    Santiago del Estero, 4200, Argentina
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • L2IP Instituto de Pesquisas Clinicas
    Brasília, 70200 730, Brazil
    Completed

    Not enrolling at this site — choose another above.

  • CAEP Centro Avancado De Estudos E Pesquisas
    Campinas, 13087 567, Brazil
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Sociedade Literaria e Caritativa Santo Agostinho Hospital Sao Jose
    Criciúma, 88811 000, Brazil
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Universidade Federal do Rio Grande do Norte Hospital Universitario Onofre Lopes
    Natal, 59012 300, Brazil
    Completed

    Not enrolling at this site — choose another above.

  • Instituto Mederi de Pesquisa e Saude
    Passo Fundo, 99010 120, Brazil
    Suspended

    Not enrolling at this site — choose another above.

  • Hospital De Clinicas De Porto Alegre
    Porto Alegre, 90035 903, Brazil
    Completed

    Not enrolling at this site — choose another above.

  • NPCRS Nucleo de Pesquisa Clinica do Rio Grande do Sul
    Porto Alegre, 90430001, Brazil
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Uniao Brasileira de Educacao e Assistencia INSCER Instituto do Cerebro do Rio Grande do Sul
    Porto Alegre, 90619900, Brazil
    Completed

    Not enrolling at this site — choose another above.

Showing the first 100 of 205 sites across 16 countries. Choose a country and city above to see the rest.

08

References and documents

Individual participant data

Plan to share: Yes — The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www janssen, com/clinical-trialsitransparency. 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

Data sharing details ↗ · www.janssen.com

No publications or documents are linked to this record.

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2024 (actual). Primary completion is estimated for Dec 2026, 29 months after the start.

Of 95 industry-sponsored phase 3 interventional studies under Depressive Disorder, Major, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 33. This study's planned 29 months is above that.

Counting every sponsor, half of 124 studies reached it within 27 months; a quarter within 21 and three quarters within 36.

Completion moved twice since we started tracking on Sep 25, 2026: Apr 2027 → May 2029, last on Nov 3, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Aug 15, 2024
First posted
Aug 19, 2024
StartActual
Jul 25, 2024
Primary completionEst.
Dec 30, 2026
CompletionEst.
May 4, 2029was Apr 2027
Last update
Nov 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
43 sites changed recruiting status (39 now active, not recruiting, 4 now completed)
Show 43 sites
  • DM Clinical Research · Houston, United StatesRecruiting→Completed
  • R and H Clinical Research · Stafford, United StatesRecruiting→Active, not recruiting
  • C I A P Centro de investigacion y Asistencia en Psiquiatria · Rosario, ArgentinaRecruiting→Active, not recruiting
  • L2IP Instituto de Pesquisas Clinicas · Brasília, BrazilSuspended→Completed
  • AGA Clinical Trials · Hialeah, United StatesRecruiting→Active, not recruiting
  • Reliable Clinical Research · Hialeah, United StatesRecruiting→Active, not recruiting
  • Advanced Research Institute of Miami · Homestead, United StatesRecruiting→Active, not recruiting
  • Clinical NeuroScience Solutions Inc · Jacksonville, United StatesRecruiting→Active, not recruiting
  • Pharmax Research Clinic Inc · Miami, United StatesRecruiting→Active, not recruiting
  • Miami Dade Medical Research Institute · Miami, United StatesRecruiting→Active, not recruiting
  • Nova Psychiatry INC · Orlando, United StatesRecruiting→Active, not recruiting
  • Advanced Discovery Research · Atlanta, United StatesRecruiting→Active, not recruiting
  • iResearch Atlanta LLC · Decatur, United StatesRecruiting→Active, not recruiting
  • CEN Consultorios Especializados en Neurociencias · Córdoba, ArgentinaRecruiting→Active, not recruiting
  • Instituto Medico DAMIC · Córdoba, ArgentinaRecruiting→Active, not recruiting
  • Centro Medico Luquez · Córdoba, ArgentinaRecruiting→Active, not recruiting
  • Sanatorio Prof Leon S Morra S A · Córdoba, ArgentinaRecruiting→Active, not recruiting
  • INSA Instituto de Neurociencias San Agustín · La Plata, ArgentinaRecruiting→Active, not recruiting
  • Clinica El Jardin · Santiago del Estero, ArgentinaRecruiting→Active, not recruiting
  • CAEP Centro Avancado De Estudos E Pesquisas · Campinas, BrazilRecruiting→Active, not recruiting
  • Sociedade Literaria e Caritativa Santo Agostinho Hospital Sao Jose · Criciúma, BrazilRecruiting→Active, not recruiting
  • NPCRS Nucleo de Pesquisa Clinica do Rio Grande do Sul · Porto Alegre, BrazilRecruiting→Active, not recruiting
  • Ruschel Medicina e Pesquisa Clínica Ltda · Rio de Janeiro, BrazilRecruiting→Active, not recruiting
  • Centro Integrado Facili · São Bernardo do Campo, BrazilRecruiting→Active, not recruiting
  • BR Trials · São Paulo, BrazilRecruiting→Active, not recruiting
  • UMHAT 'Sveti Georgi'- Plovdiv, Psychiatry Clinic · Plovdiv, BulgariaRecruiting→Active, not recruiting
  • DCC 'Sv. Vrach and Sv. Sv. Kuzma and Damyan', OOD · Sofia, BulgariaRecruiting→Active, not recruiting
  • Centro de Investigaciones y Proyectos en Neurociencias CIPNA · Barranquilla, ColombiaRecruiting→Active, not recruiting
  • HOMO - ESE Hospital Mental de Antioquia · Bello, ColombiaRecruiting→Active, not recruiting
  • Psynapsis Salud Mental S.A. · Pereira, ColombiaRecruiting→Active, not recruiting
  • …and 13 more on the registry record
across 2 updates, Sep 25, 2026 – Nov 3, 2026
Study completion
Apr 15, 2027→May 4, 2029
moved 2 times, Sep 25, 2026 – Nov 3, 2026
Show all 2 updates
  1. Nov 3, 2026
    42 sites changed recruiting status (38 now active, not recruiting, 4 now completed)
    Show 42 sites
    • AGA Clinical Trials · Hialeah, United StatesRecruiting→Active, not recruiting
    • Reliable Clinical Research · Hialeah, United StatesRecruiting→Active, not recruiting
    • Advanced Research Institute of Miami · Homestead, United StatesRecruiting→Active, not recruiting
    • Clinical NeuroScience Solutions Inc · Jacksonville, United StatesRecruiting→Active, not recruiting
    • Pharmax Research Clinic Inc · Miami, United StatesRecruiting→Active, not recruiting
    • Miami Dade Medical Research Institute · Miami, United StatesRecruiting→Active, not recruiting
    • Nova Psychiatry INC · Orlando, United StatesRecruiting→Active, not recruiting
    • Advanced Discovery Research · Atlanta, United StatesRecruiting→Active, not recruiting
    • iResearch Atlanta LLC · Decatur, United StatesRecruiting→Active, not recruiting
    • R and H Clinical Research · Stafford, United StatesCompleted→Active, not recruiting
    • CEN Consultorios Especializados en Neurociencias · Córdoba, ArgentinaRecruiting→Active, not recruiting
    • Instituto Medico DAMIC · Córdoba, ArgentinaRecruiting→Active, not recruiting
    • Centro Medico Luquez · Córdoba, ArgentinaRecruiting→Active, not recruiting
    • Sanatorio Prof Leon S Morra S A · Córdoba, ArgentinaRecruiting→Active, not recruiting
    • INSA Instituto de Neurociencias San Agustín · La Plata, ArgentinaRecruiting→Active, not recruiting
    • Clinica El Jardin · Santiago del Estero, ArgentinaRecruiting→Active, not recruiting
    • CAEP Centro Avancado De Estudos E Pesquisas · Campinas, BrazilRecruiting→Active, not recruiting
    • Sociedade Literaria e Caritativa Santo Agostinho Hospital Sao Jose · Criciúma, BrazilRecruiting→Active, not recruiting
    • NPCRS Nucleo de Pesquisa Clinica do Rio Grande do Sul · Porto Alegre, BrazilRecruiting→Active, not recruiting
    • Ruschel Medicina e Pesquisa Clínica Ltda · Rio de Janeiro, BrazilRecruiting→Active, not recruiting
    • Centro Integrado Facili · São Bernardo do Campo, BrazilRecruiting→Active, not recruiting
    • BR Trials · São Paulo, BrazilRecruiting→Active, not recruiting
    • UMHAT 'Sveti Georgi'- Plovdiv, Psychiatry Clinic · Plovdiv, BulgariaRecruiting→Active, not recruiting
    • DCC 'Sv. Vrach and Sv. Sv. Kuzma and Damyan', OOD · Sofia, BulgariaRecruiting→Active, not recruiting
    • Centro de Investigaciones y Proyectos en Neurociencias CIPNA · Barranquilla, ColombiaRecruiting→Active, not recruiting
    • HOMO - ESE Hospital Mental de Antioquia · Bello, ColombiaRecruiting→Active, not recruiting
    • Psynapsis Salud Mental S.A. · Pereira, ColombiaRecruiting→Active, not recruiting
    • Azienda Ospedaliero Univ. Policlinico Gaspare Rodolico · Catania, ItalyRecruiting→Active, not recruiting
    • Universita D Annunzio · Chieti, ItalyRecruiting→Active, not recruiting
    • Azienda Ospedaliera Sant Andrea · Roma, ItalyRecruiting→Active, not recruiting
    • …and 12 more on the registry record
    Study completion Dec 15, 2027→May 4, 2029
    + 1 other change: verification date
  2. Sep 25, 2026
    6 sites changed recruiting status (3 now completed, 2 now recruiting, …)
    Show 6 sites
    • DM Clinical Research · Houston, United StatesRecruiting→Completed
    • R and H Clinical Research · Stafford, United StatesRecruiting→Completed
    • C I A P Centro de investigacion y Asistencia en Psiquiatria · Rosario, ArgentinaRecruiting→Active, not recruiting
    • L2IP Instituto de Pesquisas Clinicas · Brasília, BrazilSuspended→Completed
    • Special Hospital for Psychiatric Diseases Kovin · Kovin, SerbiaCompleted→Recruiting
    • Specialized Hospital for Psychiatric Diseases Sveti Vracevi · Novi Kneževac, SerbiaCompleted→Recruiting
    Study completion Apr 15, 2027→Dec 15, 2027
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06559306
Lead sponsor
Janssen Research & Development, LLC
Responsible party
Sponsor
First posted
Aug 19, 2024
Start date
Jul 25, 2024
Primary completion
Dec 30, 2026 (estimated)
Completion
May 4, 2029 (estimated)
Last update
Nov 3, 2026

Study contacts

Study Contact
Contact
Participate-In-This-Study1@its.jnj.com
844-434-4210
Janssen Research & Development, LLC Clinical Trail
study director · Janssen Research & Development, LLC

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Seltorexant

Other studies in this condition

Depressive Disorder, Major →

Other studies from this sponsor

Janssen Research & Development, LLC →

Start the discussion