A Study of Seltorexant Compared to Quetiapine XR as Adjunctive Therapy to Antidepressants in Adult and Elderly Participants With Major Depressive Disorder With Insomnia Symptoms Who Have Responded Inadequately to Antidepressant Therapy
Public ClinicalTrials.gov record NCT04513912. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Double-Blind, Randomized, Parallel-Group Study With Quetiapine Extended Release as Comparator to Evaluate the Efficacy and Safety of Seltorexant 20 mg as Adjunctive Therapy to Antidepressants in Adult and Elderly Patients With Major Depressive Disorder With Insomnia Symptoms Who Have Responded Inadequately to Antidepressant Therapy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to assess the efficacy of seltorexant compared with quetiapine extended-release (XR) as adjunctive therapy to an antidepressant drug in treatment response 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).
Study identification
- NCT ID
- NCT04513912
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 757 participants
Conditions and interventions
Conditions
Interventions
- Seltorexant Drug
- Matching placebo to Seltorexant Drug
- Quetiapine XR Drug
- Matching placebo to Quetiapine XR Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 74 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 15, 2020 (Actual)
- Primary completion
- Oct 3, 2023 (Actual)
- Completion
- Oct 3, 2023 (Actual)
- Last update posted
- Aug 13, 2025
2020 – 2023
United States locations
- U.S. sites
- 75
- U.S. states
- 24
- U.S. cities
- 65
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | — |
| SW Biomedical Research LLC | Tucson | Arizona | 85712 | — |
| Proscience Research Group | Culver City | California | 90230 | — |
| Pharmacology Research Institute | Encino | California | 91316 | — |
| Collaborative NeuroScience Network | Garden Grove | California | 92845 | — |
| Collaborative NeuroScience Network | Long Beach | California | 90806 | — |
| Pharmacology Research Institute | Los Alamitos | California | 90720 | — |
| CalNeuro Research | Los Angeles | California | 90025 | — |
| Pharmacology Research Institute | Newport Beach | California | 92660 | — |
| NRC Research Institute | Orange | California | 92868 | — |
| Pacific Neuropsychiatric Specialists | Orange | California | 92868 | — |
| CNRI-Los Angeles, LLC | Pico Rivera | California | 90660 | — |
| Prospective Research Innovations Inc | Rancho Cucamonga | California | 91730 | — |
| Anderson Clinical Research | Redlands | California | 92374 | — |
| University of California at San Diego | San Diego | California | 92103 | — |
| National Research Institute | Santa Ana | California | 91704 | — |
| CI Trials | Santa Ana | California | 92705 | — |
| CMB Clinical Trials | Santee | California | 92071 | — |
| Schuster Medical Research Institute | Sherman Oaks | California | 91403 | — |
| Pacific Clinical Research Medical Group | Upland | California | 91786 | — |
| Hartford Hospital | Hartford | Connecticut | 06102 | — |
| Moonshine Research Center, Inc | Doral | Florida | 33166 | — |
| Velocity Clinical Research, Hallandale Beach | Hallandale | Florida | 33009 | — |
| Indago Research & Health Center Inc | Hialeah | Florida | 33012 | — |
| New Life Medical Research Center, Inc. | Hialeah | Florida | 33012 | — |
| Amedica Research Institute Inc | Hialeah | Florida | 33013 | — |
| Meridien Research | Lakeland | Florida | 33803 | — |
| Premier Clinical Research | Miami | Florida | 33122 | — |
| Global Medical Institutes | Miami | Florida | 33125 | — |
| Miami Jewish Health System | Miami | Florida | 33137 | — |
| Clinical Neuroscience Solutions | Orlando | Florida | 23801 | — |
| Synexus Research Orlando | Orlando | Florida | 32806 | — |
| University of South Florida | Tampa | Florida | 33612 | — |
| Compass Research LLC-Bioclinica Research | The Villages | Florida | 32162 | — |
| Synexus Clinical Research US Inc | Atlanta | Georgia | 30328 | — |
| Atlanta Center for Medical Research | Atlanta | Georgia | 30331 | — |
| iResearch Atlanta LLC | Decatur | Georgia | 30030 | — |
| Psych Atlanta, P.C. | Marietta | Georgia | 30060 | — |
| Chicago Research Center | Chicago | Illinois | 60634 | — |
| Capstone Clinical Research | Libertyville | Illinois | 60048 | — |
| Alexian Brothers Health System | Lisle | Illinois | 60532 | — |
| Baber Research Group | Naperville | Illinois | 60563 | — |
| Lemah Creek Clinical Research | Oakbrook Terrace | Illinois | 60618 | — |
| Ascension via Christi Research | Wichita | Kansas | 67214 | — |
| Riverstar Research | New Orleans | Louisiana | 70115 | — |
| Pharmasite Research, Inc. | Baltimore | Maryland | 21208 | — |
| BTC of New Bedford | New Bedford | Massachusetts | 02740 | — |
| Boston Clinical Trials & Medical Research | Roslindale | Massachusetts | 02135 | — |
| Psychiatric Care and Research Center (PCRC) | O'Fallon | Missouri | 63368 | — |
| Bio Behavioral Health | Toms River | New Jersey | 08755 | — |
| SPRI Clinical Trials, LLC | Brooklyn | New York | 11235 | — |
| Fieve Clinical Research Inc | New York | New York | 10017 | — |
| The Medical Research Network, LLC | New York | New York | 10128 | — |
| Finger Lakes Clinical Research | Rochester | New York | 14618 1609 | — |
| Richmond Behavioral Associates | Staten Island | New York | 10312 | — |
| Velocity Clinical Research, Inc. | Durham | North Carolina | 27701 | — |
| University of Cincinnati, Dept of Psychiatry & Behavioral Neuroscience | Cincinnati | Ohio | 45219 | — |
| Midwest Clinical Research Center | Dayton | Ohio | 45417 | — |
| Neuro Behavioral Clinical Research | North Canton | Ohio | 44720 | — |
| Sooner Clinical Research | Oklahoma City | Oklahoma | 73112 | — |
| Paradigm Research Professionals, LLC | Oklahoma City | Oklahoma | 73118 | — |
| Suburban Research Associates | Pine Hill | Pennsylvania | 08021 | — |
| Global Medical Institutes | Scranton | Pennsylvania | 18503 | — |
| Coastal Carolina Research Center | Mt. Pleasant | South Carolina | 29464 | — |
| West Houston Clinical Research Service | Bellaire | Texas | 77401 | — |
| North Texas Clinical Trials | Fort Worth | Texas | 76104 | — |
| Hawkins Psychiatry, PC | Mansfield | Texas | 76054 | — |
| Family Psychiatry of The Woodlands | The Woodlands | Texas | 77381 | — |
| Grayline Research Center | Wichita Falls | Texas | 76309 | — |
| Alpine Research Organization | Clinton | Utah | 84015 | — |
| Cedar Clinical Research | Draper | Utah | 84020 | — |
| University of Virginia | Charlottesville | Virginia | 22903 | — |
| Northwest Clinical Research Center | Bellevue | Washington | 98007 | — |
| Core Clinical Research | Everett | Washington | 98201 | — |
| Cary J. Kohlenberg, MD, SC, dba, IPC Research. | Waukesha | Wisconsin | 53188 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 100 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04513912, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 13, 2025 · Synced Oct 26, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04513912 live on ClinicalTrials.gov.