Depressive Disorder, Major study: Seltorexant
Official title Phase 3 Study of Adjunctive Treatment With Seltorexant in Adult and Elderly Participants With Major Depressive Disorder and Insomnia Symptoms
ClinicalTrials.gov ID: NCT06559306
What this study is testing
What is Seltorexant?
Seltorexant is an investigational oral medication being studied as a potential adjunctive therapy for major depressive disorder with insomnia symptoms.
Also referred to as JNJ 42847922.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether seltorexant helps improve depression and sleep when added to an antidepressant. It also looks at how safe it is and if it keeps working over time.
- Who it's for
- You may be able to join if you are an adult or older adult with major depression and trouble sleeping, and your current antidepressant hasn’t helped enough.
- What's involved
- You will take seltorexant at home while continuing your usual antidepressant. You will have visits to check your mood, sleep, and any side effects.
- Time commitment
- The study lasts about 12 weeks, with several clinic visits during that time.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 74
You may be able to join if
- Meet DSM-5 MDD, without psychotic features based upon clinical assessment and confirmed by the structured clinical interview for DSM-5 Axis I...
- 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...
- 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...
- 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
You likely can't join if
- Has a recent (last 3 months) history of, or current signs and symptoms of, severe renal insufficiency clinically significant or unstable...
- 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
See the full eligibility criteria
- Meet DSM-5 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...
- 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.
- 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...
- 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
- Has a recent (last 3 months) history of, or current signs and symptoms of, severe renal insufficiency clinically significant or unstable cardiovascular, respiratory, gastrointestinal, neurologic, hematologic...
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Tucson, Arizona, United States
- Bryant, Arkansas, United States
- Anaheim, California, United States
- Colton, California, United States
- Glendale, California, United States
- Oceanside, California, United States
- Redlands, California, United States
- San Jose, California, United States
- Denver, Colorado, United States
- Farmington, Connecticut, United States
- Brandon, Florida, United States
- Miami, Florida, United States
- Tampa, Florida, United States
- West Palm Beach, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Naperville, Illinois, United States
- Watertown, Massachusetts, United States
- Brooklyn, New York, United States
- Mount Kisco, New York, United States
+ 41 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 74 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Tucson, Arizona, United States; Bryant, Arkansas, United States; Anaheim, California, United States; Colton, California, United States; Glendale, California, United States; Oceanside, California, United States and 55 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.