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 Therapy
Public ClinicalTrials.gov record NCT04532749. 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
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 a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI).
Study identification
- NCT ID
- NCT04532749
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 212 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 (Actual)
- Primary completion
- May 24, 2022 (Actual)
- Completion
- Jul 14, 2022 (Actual)
- Last update posted
- Jun 4, 2025
2020 – 2022
United States locations
- U.S. sites
- 26
- U.S. states
- 12
- U.S. cities
- 23
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Altea Research Institute | Phoenix | Arizona | 85012 | — |
| Preferred Research Partners | Little Rock | Arkansas | 72211 | — |
| Behavioral Research Specialists LLC | Glendale | California | 91206 | — |
| Sun Valley Research Center | Imperial | California | 92251 | — |
| Alliance for Research | Long Beach | California | 90807 | — |
| Excell Research Inc | Oceanside | California | 92056 | — |
| California Neuroscience Research Medical Group, Inc. | Sherman Oaks | California | 91403 | — |
| Pharmax Research Clinic Inc | Miami | Florida | 33126 | — |
| Innova Clinical Trials | Miami | Florida | 33133 | — |
| Harmony Clinical Research Inc | North Miami Beach | Florida | 33162 | — |
| Medical Research Group of Central Florida | Orange City | Florida | 32763 | — |
| Synexus Research Orlando | Orlando | Florida | 32806 | — |
| Stedman Clinical Trials | Tampa | Florida | 33613 | — |
| Compass Research LLC-Bioclinica Research | The Villages | Florida | 32162 | — |
| Synexus Clinical Research US Inc | Atlanta | Georgia | 30328 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| Uptown Research Institute, LLC | Chicago | Illinois | 60640 | — |
| Phoenix Medical Research, Inc. | Prairie Village | Kansas | 66206 | — |
| Michigan Clinical Research Institute | Ann Arbor | Michigan | 48108 | — |
| Eastside Comprehensive Medical Services | New York | New York | 10128 | — |
| Community Research Management Associates, Inc. | Cincinnati | Ohio | 45212 | — |
| Patient Priority Clinical Sites LLC | Cincinnati | Ohio | 45215 | — |
| Intend Research | Norman | Oklahoma | 73069 | — |
| IPS Research Company | Oklahoma City | Oklahoma | 73106 | — |
| InSite Clinical Research LLC | DeSoto | Texas | 75115 | — |
| Pillar Clinical Research, LLC | Richardson | Texas | 75080 | — |
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 54 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04532749, 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 Jun 4, 2025 · Synced Oct 24, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04532749 live on ClinicalTrials.gov.