A Study of Seltorexant as Monotherapy in Adults and Elderly Participants With Major Depressive Disorder
Recruiting · NCT07573176 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
PlaceboSeltorexant
What this trial is about
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.
Who can take part
Age range
18 Years to 74 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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
- Experienced at least one MDD episode prior to their current episode
- Current episode of MDD must be a minimum of 2 weeks in duration
- Must meet one of the following criteria regarding current medication status.
- Can be presenting for a new episode of MDD on no antidepressant treatment; 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 (medical record/source document).
- Have taken up to two antidepressant treatments started in the current episode that were stopped (withdrawn), or will be withdrawn (washed out) due to inadequate response or intolerance.
- 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)
Exclusion criteria
- 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
- 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
Where it is running
39 locations listed across 14 US states.
- SanRo Clinical Research Group LLC WCG Clinical Network - Bryant, Arkansas, United States
- CI Trials - Bellflower, California, United States
- Behavioral Research Specialists LLC - Glendale, California, United States
- Excell Research Inc - Oceanside, California, United States
- NRC Research Institute - Orange, California, United States
- Cenexel - Riverside, California, United States
- Sunwise Clinical Research - Walnut Creek, California, United States
- UHC Research - Doral, Florida, United States
- Reliable Clinical Research - Hialeah, Florida, United States
- Nuovida Research Center - Miami, Florida, United States
- IPTB Clinical Research - Tampa, Florida, United States
- Health Synergy Clinical Research - West Palm Beach, Florida, United States
- Agile Clinical Research Trials, LLC - Atlanta, Georgia, United States
- Accelerated Clinical Research Group LLC - Snellville, Georgia, United States
- Chicago Research Center - Chicago, Illinois, United States
- Pharmasite Research, Inc. - Baltimore, Maryland, United States
- Adams Clinical Boston - Boston, Massachusetts, United States
- Adams Clinical Watertown - Watertown, Massachusetts, United States
- CenExel Marlton NJ - Marlton, New Jersey, United States
- Integrative Clinical Trials LLC - Brooklyn, New York, United States
- SPRI Clinical Trials, LLC - Brooklyn, New York, United States
- Bioscience Research LLC - Mount Kisco, New York, United States
- Fieve Clinical Research Inc - New York, New York, United States
- Adams Clinical Harlem - New York, New York, United States
- Manhattan Behavioral Medicine - New York, New York, United States
- Magnolia Clinical Research LLC - Cary, North Carolina, United States
- Patient Priority Clinical Sites LLC - Cincinnati, Ohio, United States
- Conrad Clinical Research - Edmond, Oklahoma, United States
- Sooner Clinical Research - Oklahoma City, Oklahoma, United States
- Alpine Research Organization - Clinton, Utah, United States
- Northwest Clinical Research Center - Bellevue, Washington, United States
- University Malaya Medical Centre - Kuala Lumpur, Malaysia
- Centro Integrado Facili - São Bernardo do Campo, Brazil
- BR Trials - São Paulo, Brazil
- Chung Shan Medical University Hospital - Taichung, Taiwan
- Taipei Mackay Memorial Hospital - Taipei, Taiwan
- Taipei Medical University Hospital - Taipei, Taiwan
- Taipei Veterans General Hospital - Taipei, Taiwan
- Medical Arts Research Health Group - North Vancouver, British Columbia, Canada