RightFit
RecruitingPhase 3

A Study of Seltorexant as Monotherapy in Adults and Elderly Participants With Major Depressive Disorder

A Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate Efficacy and Safety of Seltorexant as Monotherapy in Adult and Elderly Participants With Major Depressive Disorder (MDD) and an Open-label Long-term Extension Treatment With Seltorexant

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 74 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests seltorexant (JNJ-42847922), used alone, for adults and older adults with major depression. It compares the drug with a placebo (a treatment with no active drug) to see whether it improves depression symptoms. It also checks long-term safety and how well people tolerate the drug.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have major depression confirmed by study doctors, without psychotic symptoms such as seeing or hearing things that are not there. Your first depression episode must have started before age 55.
  • Have had at least one earlier depression episode confirmed by a doctor and recorded in your medical records.
  • Your current depression episode has lasted 8 weeks to 24 months.
  • Meet one of two medicine rules: You have not started adequate antidepressant treatment for this episode, but took an antidepressant at a stable, treatment-level dose for at least 6 weeks during an earlier episode; OR you started up to two antidepressant treatments for this episode that were stopped, or will be stopped, because they did not work well enough.
  • Have a body mass index (BMI), a measure based on height and weight, between 18 and 40.
  • Be medically stable at screening and at the start of treatment, based on a physical exam, blood pressure and other vital signs, and an ECG (a heart rhythm test).

Who can't join

  • Used ketamine or esketamine during this depression episode. Up to two doses before screening are allowed. You also cannot have treatment-resistant depression, meaning depression that has not responded to treatment.
  • Have panic disorder, generalized anxiety, social anxiety, or a specific phobia as your main diagnosis and the main focus of mental health treatment in the past 2 years.
  • Currently have obsessive-compulsive disorder (unwanted thoughts and repeated actions), posttraumatic stress disorder (symptoms after trauma), anorexia or bulimia (eating disorders), or fibromyalgia (a condition causing widespread pain).
  • Have a past or current diagnosis of a psychotic disorder, bipolar disorder, autism, borderline personality disorder, or a somatoform disorder (physical symptoms linked to mental distress).
  • Have dementia, a disease that causes dementia, an intellectual disability, or another disorder affecting memory and thinking.
  • Have current or recent thoughts of killing someone, serious thoughts of suicide in the past 3 months, or suicidal behavior in the past 6 months.
  • Have had a moderate or severe substance use disorder, including alcohol use disorder, within the past 6 months.
  • Have a significant sleep disorder, including untreated or uncontrolled conditions; or have an allergy, intolerance, or other medical reason you cannot take seltorexant or its ingredients.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 and confirmed by the SCID-CT diagnosed with first depressive episode prior to age 55 * Experienced at least one MDD episode prior to their current episode based on clinician-confirmed MDD diagnosis/MDE and documented in source records * Current episode of MDD must be a minimum of 8 weeks in duration and maximum of 24 months duration * Must meet one of the following criteria regarding current medication status. 1. Can be presenting for a new episode of MDD with no adequate antidepressant treatment started in the current episode; 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. OR 2. 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 as defined by the Massachusetts general hospital antidepressant treatment response questionnaire (MGH-ATRQ) * 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

Study sites (34)

AR

CA

FL

GA

IL

MA

MD

NC

NJ

NV

NY

OH

OK

TX

UT

WA