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

Plain English Summary

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 is a Phase 3 clinical trial sponsored by Janssen Research & Development, LLC studying Depressive Disorder, Major. Tests if Seltorexant helps adults and elderly with depression and insomnia who didn’t fully respond to antidepressants. For adults and elderly with major depressive disorder and insomnia who have tried 1-2 antidepressants without full improvement. Participation involves taking Seltorexant or a placebo for 43 days and answering questions about mood and sleep. Alternative treatments include other antidepressants or therapy. The trial aims to enroll 212 participants.

Official Summary

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).

Who Can Participate

Here is what you need to know about eligibility for this trial. Adults and elderly with major depressive disorder and insomnia who have tried 1-2 antidepressants without full improvement can join. Those with severe kidney problems, recent heart issues, or other serious health conditions cannot join. Age range: 18-80 years old. Good overall health and stable on current medications. This trial is studying Depressive Disorder, Major, so participants generally need a confirmed diagnosis.

What They're Measuring

Improvements in mood and sleep are key outcomes, helping patients manage their depression better. The specific primary outcome measures are: Change From Baseline to Day 43 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (Baseline (Day 1), Day 43). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.

Why This Trial Matters

This trial fills a gap by testing a new treatment for depression with insomnia in those who haven’t fully responded to other treatments. As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Depressive Disorder, Major, where improved treatment options are needed.

Investor Insight

The large market for depression treatments and the need for new options make this trial significant for investors. Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage.

Is This Trial Right for Me?

Ask your doctor if you have tried 1-2 antidepressants without full improvement and have insomnia. Participation involves taking a pill daily and answering questions about your mood and sleep. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: DOUBLE
• Enrollment: 212 participants

Interventions

• DRUG: Seltorexant — Participants will receive Seltorexant tablets.
• DRUG: Placebo — Participants will receive matching placebo tablets.

Primary Outcomes

• Change From Baseline to Day 43 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (Baseline (Day 1), Day 43)

Secondary Outcomes

• Change From Baseline to Day 43 in the MADRS Without Sleep Item (MADRS-WOSI) Total Score (Baseline (Day 1), Day 43)
• Change From Baseline to Day 43 in Sleep Disturbance Using the Patient Reported Outcome Measurement Information System-Sleep Disturbance (PROMIS-SD; Short Form 8a) T-score (Baseline (Day 1), Day 43)
• Change From Baseline to Day 43 in the 6-item MADRS (MADRS-6) Total Score (Baseline (Day 1), Day 43)
• Percentage of Participants Who Achieved Response on Depressive Symptoms Scale Based on MADRS Total Score at Day 43 (At Day 43)
• Change From Baseline to Day 43 in Patient Health Questionnaire, 9-item (PHQ-9) Total Score (Baseline (Day 1), Day 43)

Full 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 structured clinical interview for DSM-5 Axis I disorders-clinical trials version (SCID-CT) diagnosed with first depressive episode prior to age 60. The duration of the current depressive episode must be less than or equal to (\<=) 24 months
* 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. The current antidepressant cannot be the first antidepressant treatment for the first lifetime episode of depression. An inadequate response is defined as less than (\<) 50 percent (%) reduction but with some improvement (that is, improvement greater than \[\>\] 0%) in depressive symptom severity with residual symptoms other than insomnia present, and overall good tolerability, as assessed by the MGH-ATRQ
* Is receiving and tolerating well any one of the following selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI) for depressive symptoms at screening, in any formulation and available in the participating country: citalopram, duloxetine, escitalopram, fluvoxamine, fluoxetine, milnacipran, levomilnacipran, paroxetine, sertraline, venlafaxine, desvenlafaxine, vilazodone, or vortioxetine at a stable dose (at therapeutic dose level) for at least 6 weeks, and for no greater than 18 months in the current episode
* Have a hamilton depression rating scale (HDRS)-17 total score greater than or equal to (\>=) 20 at the first screening interview, must not demonstrate a clinically significant improvement (that is \[ie\], an improvement of \> 20 % on their HDRS-17 total score) from the first to the second independent HDRS-17 rating, and must have a HDRS-17 total score \>= 18 at the second screening interview
* Have a patient version of the Insomnia Severity Index (ISI) total score \>=15 as well as a clinician version of the ISI total score \>=15 at the second screening visit
* Body mass index (BMI) between 18 and 40 kilogram per meter square (kg/m\^2) inclusive (BMI=weight/height\^2)
* Participant must be medically stable on the basis of clinical laboratory tests performed at screening
* Participant must be medically stable on the basis of the following: physical examination (including a brief neurological examination), vital signs (including blood pressure), and 12-lead electrocardiogram (ECG) performed at screening and baseline

Exclusion Criteria:

* Has a recent (last 3 months) history of, or current signs and symptoms of, severe renal insufficiency (creatinine clearance \[CrCl\] \< 30 milliliter per minute \[mL/min\]); clinically significant or unstable cardiovascular, respiratory, gastrointestinal, neurologic, hematologic, rheumatologic, immunologic or endocrine disorders and uncontrolled Type 1 or Type 2 diabetes mellitus
* Has clinically significant hepatic disease as defined by \>=2\*Upper Limit of Normal (ULN) increase of aspartate aminotransferase (AST) or alanine aminotransferase (ALT) at screening
* Has a history of treatment-resistant MDD, defined as a lack of response to 2 or more adequate antidepressant treatments in the current episode, as indicated by no or minimal (\< 25% improvement in symptoms) when treated with an antidepressant of adequate dose (per massachusetts general hospital-antidepressant treatment response questionnaire \[MGH-ATRQ\]) and duration (at least 6 weeks).
* Has history or current diagnosis of a psychotic disorder, bipolar disorder, intellectual disability, autism spectrum disorder, borderline personality disorder, or somatoform disorders
* Has any significant primary sleep disorder, including but not limited to obstructive sleep apnea, restless leg syndrome, or parasomnias. Participants with insomnia disorder are allowed
* Has a history of moderate to severe substance use disorder including alcohol use disorder according to DSM-5 criteria within 6 months before screening

Trial Locations

• Altea Research Institute, Phoenix, Arizona, United States
• Preferred Research Partners, Little Rock, Arkansas, United States
• Behavioral Research Specialists LLC, Glendale, California, United States
• Sun Valley Research Center, Imperial, California, United States
• Alliance for Research, Long Beach, California, United States
• Excell Research Inc, Oceanside, California, United States
• California Neuroscience Research Medical Group, Inc., Sherman Oaks, California, United States
• Pharmax Research Clinic Inc, Miami, Florida, United States
• Innova Clinical Trials, Miami, Florida, United States
• Harmony Clinical Research Inc, North Miami Beach, Florida, United States
• ...and 10 more locations

Frequently Asked Questions

Related Conditions

• Major Depressive Disorder, Insomnia, Depression, Sleep Disorders, Anxiety Disorders

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