A Study of Seltorexant as Adjunctive Therapy to Antidepressants in Adult and Elderly Participants With Major Depressive Disorder With Insomnia Symptoms Who Have Responded Inadequately to Antidepressant and Long-term Safety Extension Treatment With Seltorexant
Public ClinicalTrials.gov record NCT04533529. 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
A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled, Study 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 and an Open-labeled Long-term Safety Extension Treatment With Seltorexant
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 placebo as 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 an selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI) in double-blind treatment phase and to assess the long-term safety and tolerability of seltorexant as adjunctive therapy to an antidepressant in participants with major depressive disorder (MDD) in open-label treatment phase.
Study identification
- NCT ID
- NCT04533529
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 588 participants
Conditions and interventions
Conditions
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
- Primary completion
- Apr 24, 2023
- Completion
- Apr 29, 2024
- Last update posted
- May 11, 2026
2020 – 2024
United States locations
- U.S. sites
- 51
- U.S. states
- 18
- U.S. cities
- 45
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Advanced Research Center Inc | Anaheim | California | 92805 | — |
| Synexus | Cerritos | California | 90703 | — |
| Irvine Clinical Research | Irvine | California | 92614 | — |
| Omega Clinical Trials LLC | La Habra | California | 90631 | — |
| Synergy East | Lemon Grove | California | 91945 | — |
| Semel Institute for Neuroscience and Human Behavior | Los Angeles | California | 90048 | — |
| Catalina Research Institute | Montclair | California | 91763 | — |
| Pacific Research Partners | Oakland | California | 94607 | — |
| North County Clinical Research | Oceanside | California | 92056 | — |
| Syrentis Clinical Research | Santa Ana | California | 92705 | — |
| Viking Pharmaceutical Trials Inc. dba Viking Clinical Research | Temecula | California | 92591 | — |
| Connecticut Clinical Trials LLC | Cromwell | Connecticut | 06416 | — |
| University of Connecticut Health Center | Farmington | Connecticut | 06030 | — |
| Sarkis Clinical Trials | Gainesville | Florida | 32607 | — |
| Clinical NeuroScience Solutions Inc | Jacksonville | Florida | 32256 | — |
| Pharmax Research Clinic Inc | Miami | Florida | 33126 | — |
| Medical Research Center of Miami II Inc | Miami | Florida | 33134 | — |
| Phoenix Medical Research, Inc. | Miami | Florida | 33165 | — |
| Galiz Research | Miami Springs | Florida | 33166 | — |
| Bravo Health Care Center | North Bay Village | Florida | 33141 | — |
| APG Research LLC | Orlando | Florida | 32803 | — |
| Combined Research Orlando | Orlando | Florida | 32803 | — |
| Nova Psychiatry INC | Orlando | Florida | 32803 | — |
| Revive Research Institute | Elgin | Illinois | 60123 | — |
| Joliet Center for Clinical Research | Joliet | Illinois | 60435 | — |
| Baber Research Group | Naperville | Illinois | 60563 | — |
| American Medical Research, Inc. | Oak Brook | Illinois | 60523 | — |
| Southern Illinois University School of Medicine | Springfield | Illinois | 62701 | — |
| Louisiana Clinical Research | Shreveport | Louisiana | 71101 | — |
| Adams Clinical | Watertown | Massachusetts | 02472 | — |
| Neurobehavioral Medicine Group | Bloomfield Hills | Michigan | 48302 | — |
| Midwest Research Group - St. Charles Psychiatric Associates | Saint Charles | Missouri | 63301 | — |
| Mid-America Clinical Research, LLC | St Louis | Missouri | 63109 | — |
| PsychCare Consultants Research | St Louis | Missouri | 63128 | — |
| Premier Psychiatric Research Institute, LLC | Lincoln | Nebraska | 68526 | — |
| Altea Research Institute | Las Vegas | Nevada | 89102 | — |
| Hassman Research Institute, LLC. | Berlin | New Jersey | 08009 | — |
| Synexus Clinical Research US Inc | Jamaica | New York | 11432 | — |
| Bioscience Research LLC | Mount Kisco | New York | 10549 | — |
| Haidar Almhana Nieding | Avon Lake | Ohio | 44012 | — |
| The Ohio State University | Columbus | Ohio | 43221 | — |
| Lindner Center of Hope | Mason | Ohio | 45040 | — |
| Oklahoma Clinical Research Center | Oklahoma City | Oklahoma | 73112 | — |
| Lehigh Center for Clinical Research | Allentown | Pennsylvania | 18104 | — |
| University of Pennsylvania - Perelman School of Medicine | Philadelphia | Pennsylvania | 19104 | — |
| Relaro Medical Trials | Dallas | Texas | 75243 | — |
| North Texas Clinical Trials | Fort Worth | Texas | 76104 | — |
| Baylor College of Medicine | Houston | Texas | 77030 | — |
| Red Oak Psychiatry Associates | Houston | Texas | 77090 | — |
| Alpine Research Organization | Clinton | Utah | 84015 | — |
| Green Mountain Research Institute | Rutland | Vermont | 05701 | — |
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 71 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04533529, 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 May 11, 2026 · Synced Sep 25, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04533529 live on ClinicalTrials.gov.