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New treatment option for Depressive Disorder, Major
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 medicine, given as a pill taken by mouth, being studied as a potential treatment for depressive disorder, major.
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
- The purpose of this study is to know how well seltorexant works, and also to evaluate safety and maintenance effect of seltorexant compared with placebo as an 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).
- 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
- Participants in part 1 and direct enrollers to part 2:
- 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...
- Having a major depressive episode of at least moderate severity, as assessed with 17-item Hamilton Depression Rating Scale, implemented through the...
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
- Participants in part 1 and direct enrollers to part 2:
- 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. An inadequate response is defined as less than (\ ]...
- 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...
- Having a major depressive episode of at least moderate severity, as assessed with 17-item Hamilton Depression Rating Scale, implemented through the Structured Interview Guide (SIGH-D) in a blinded manner at screening...
- 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's taking place
- Birmingham, Alabama, United States
- Chandler, Arizona, United States
- Tucson, Arizona, United States
- Bryant, Arkansas, United States
- Little Rock, Arkansas, United States
- Anaheim, California, United States
- Colton, California, United States
- Encino, California, United States
- Glendale, California, United States
- Los Alamitos, California, United States
- Oceanside, California, United States
- Rancho Cucamonga, California, United States
- Redlands, California, United States
- San Jose, California, United States
- Santa Ana, California, United States
- Sherman Oaks, California, United States
- Denver, Colorado, United States
- Farmington, Connecticut, United States
- Brandon, Florida, United States
- Hialeah, Florida, United States
+ 136 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 - 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?
Study sites include Birmingham, Alabama, United States; Chandler, Arizona, United States; Tucson, Arizona, United States; Bryant, Arkansas, United States; Little Rock, Arkansas, United States; Anaheim, California, United States and 150 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.