Seltorexant for Depression

Recruiting at 152 trial locations

Overseen By Study Contact

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Janssen Research & Development, LLC

Must be taking: SSRIs, SNRIs

Must not be taking: Thyroid supplements

Disqualifiers: Severe renal insufficiency, Cardiovascular, Diabetes, others

Stay on Your Current Meds You can continue your current medications while participating

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

752 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, seltorexant, for individuals with major depressive disorder who also experience insomnia. The researchers aim to determine if adding seltorexant to current antidepressant treatments improves depression symptoms more effectively than a placebo. Participants will take either seltorexant or a placebo, along with their usual antidepressants, to evaluate its efficacy and safety. Suitable candidates have been dealing with depression and insomnia, have seen some improvement, but still experience symptoms despite using antidepressants like SSRIs or SNRIs. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

No, you will not have to stop taking your current medications. The trial is designed to test seltorexant as an additional treatment alongside your existing antidepressant medication.

Is there any evidence suggesting that seltorexant is likely to be safe for humans?

Research has shown that seltorexant is generally well-tolerated. In one study, seltorexant alone treated major depressive disorder (MDD) safely compared to a placebo. Another study tested seltorexant with an antidepressant and found it improved depressive symptoms with fewer side effects than quetiapine XR.

A different study examined seltorexant for insomnia (difficulty sleeping) and also found it safe and effective. While any medication can have side effects, these studies suggest that seltorexant is generally safe for treating depression and sleep problems. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Seltorexant is unique because it targets the orexin system, unlike most standard depression treatments that focus on serotonin or norepinephrine pathways. This novel approach may offer benefits for patients who don't fully respond to traditional selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs). Researchers are excited because seltorexant could potentially improve symptoms of depression, particularly related to sleep disturbances, more effectively than existing medications. Its different mechanism of action opens up new possibilities for those seeking alternative treatment options.

What evidence suggests that seltorexant could be an effective treatment for major depressive disorder with insomnia symptoms?

Research has shown that seltorexant can greatly alleviate depression symptoms. In this trial, participants in the experimental arms will receive seltorexant, which studies have found to noticeably reduce the severity of depression, especially in those with sleep difficulties. Compared to other treatments, seltorexant improved mood more effectively and caused fewer side effects. One study found that combining seltorexant with antidepressants led to a significant decrease in depression symptoms. These findings suggest that seltorexant could benefit people dealing with depression and sleep problems. ^{3 6 7 8 9}

Who Is on the Research Team?

Janssen Research & Development, LLC Clinical Trail

Principal Investigator

Janssen Research & Development, LLC

Are You a Good Fit for This Trial?

This trial is for adults and elderly with major depressive disorder (MDD) who also have insomnia symptoms. Participants must be currently taking an SSRI or SNRI but not fully responding to it.

Inclusion Criteria

Are you currently on a stable dose of medication for your depression?

Are you struggling to find relief for your depression symptoms on your current medication?

Have you been feeling down or depressed most of the day, nearly everyday?

Exclusion Criteria

Do you have a history of narcolepsy or seizures?

Have you been diagnosed with Bipolar Disorder?

Are you taking thyroid supplementation for antidepressant purposes

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part 1

Participants receive seltorexant or placebo orally once daily for 6 weeks during the double-blind treatment phase

6 weeks

Weekly visits (in-person)

Follow-up Part 1

Participants who do not proceed to Part 2 undergo a post-treatment follow-up phase

4 weeks

Open Label Phase Part 2

Participants receive seltorexant orally in addition to their background SSRI/SNRI treatment during the open-label induction and stabilization phases

Variable

Double-Blind Maintenance Phase Part 2

Participants who achieve a stable response during the open-label phase receive seltorexant or placebo during the double-blind maintenance phase

Up to 337 days

Follow-up Part 2

Participants are monitored for safety and effectiveness after the maintenance phase

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Seltorexant

Trial Overview The study tests if adding Seltorexant to existing antidepressant therapy (SSRI/SNRI) is more effective than a placebo in improving depression and sleep in patients with MDDIS.

How Is the Trial Designed?

Group I: Part 2: Open Label (OL) Seltorexant Experimental Treatment 2 Interventions

All participants who complete Part 1, and who meet eligibility criteria for Part 2, as well as direct entry participants, will enter Part 2 of the study. In Part 2 open-label phases (induction and stabilization) all participants (newly enrolled direct entry participants and Part 1 roll-over participants) will receive seltorexant orally in addition to their background SSRI/SNRI treatment.

Group II: Part 2: DB Seltorexant Experimental Treatment 2 Interventions

All participants who complete Part 1, and who meet eligibility criteria for Part 2, as well as direct entry participants, will enter Part 2 of the study. Participants who achieve a stable response during the open-label phase will receive treatment with seltorexant orally once daily during DB Maintenance Phase in Part 2 of the study. Participants will continue to take their single baseline SSRI/SNRI antidepressant throughout the study.

Group III: Part 1: Seltorexant Experimental Treatment 2 Interventions

Participants will receive seltorexant orally once daily for 6 weeks during the double-blind (DB) treatment phase in Part 1 of the study. Participants who do not proceed to Part 2 of the study will undergo a post-treatment follow-up phase, after the DB treatment phase in Part 1 and will continue to take their single baseline selective serotonin reuptake inhibitor (SSRI)/serotonin-norepinephrine reuptake inhibitor (SNRI) antidepressant throughout the study.

Group IV: Part 1: Placebo Placebo Group 2 Interventions

Participants will receive matching placebo orally once daily for 6 weeks during the DB treatment phase in Part 1 of the study. Participants who do not proceed to Part 2 of the study will undergo a post-treatment follow-up phase, after the DB treatment phase in Part 1 and will continue to take their single baseline SSRI/SNRI antidepressant throughout the study.

Group V: Part 2: DB Placebo Placebo Group 2 Interventions

All participants who complete Part 1, and who meet eligibility criteria for Part 2, as well as direct entry participants, will enter Part 2 of the study. Participants who achieve a stable response during the open-label phases will receive treatment with matching placebo orally once daily during DB Maintenance Phase in Part 2 of the study. Participants will continue to take their single baseline SSRI/SNRI antidepressant throughout the study.

Who Is Running the Clinical Trial?

Janssen Research & Development, LLC

Lead Sponsor

Trials

1,022

Recruited

6,408,000+

Joaquin Duato

Janssen Research & Development, LLC

Chief Executive Officer since 2022

MBA from ESADE, Master of International Management from Thunderbird School of Global Management

Dr. Jijo James, MD

Janssen Research & Development, LLC

Chief Medical Officer since 2014

MD from St. Johns Medical College, MPH from Columbia University

Citations

1. jnj.com jnj.com/media-center/press-releases/johnson-johnson-pivotal-study-of-seltorexant-shows-statistically-significant-and-clinically-meaningful-improvement-in-depressive-symptoms-and-sleep-disturbance-outcomes

Seltorexant, an investigational first-in- ... Johnson & Johnson pivotal study of seltorexant shows statistically significant and clinically meaningful improvement in depressive symptoms and ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31481683/

The selective orexin-2 antagonist seltorexant (JNJ- ... Ten days of treatment with seltorexant (and not diphenhydramine) resulted in a significant improvement of core depressive symptoms compared to ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03227224

NCT03227224 | A Study to Evaluate the Efficacy and ... The study will investigate the antidepressant effects of a range of doses of JNJ-42847922 (seltorexant) (versus placebo), as adjunctive treatment to ...

4. jnj.com jnj.com/media-center/press-releases/johnson-johnsons-investigational-seltorexant-shows-numerically-higher-response-in-patients-with-depression-with-insomnia-symptoms-with-fewer-side-effects-compared-to-quetiapine-xr

Seltorexant, in combination with an oral antidepressant ... Seltorexant and quetiapine XR showed large and clinically meaningful improvements in depressive symptoms (-23.0 and -22.7, respectively), as ...

5. nature.com nature.com/articles/s41380-024-02846-5

Treatment effect and safety of seltorexant as monotherapy ... The improvement in depression severity at week 6 for seltorexant 20 mg was greater in patients with moderate-severe insomnia at baseline, ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39663378/

Treatment effect and safety of seltorexant as monotherapy ... The antidepressant efficacy and safety of seltorexant monotherapy in major depressive disorder (MDD) was investigated in a placebo-controlled, placebo lead-in, ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04533529

NCT04533529 | A Study of Seltorexant as Adjunctive ... The purpose of this study is to assess the efficacy of seltorexant compared with placebo as adjunctive therapy to an antidepressant in improving depressive ...

8. jamanetwork.com jamanetwork.com/journals/jamapsychiatry/fullarticle/2837250

Efficacy and Safety of Seltorexant in Insomnia Disorder This randomized clinical trial evaluates the safety and efficacy of seltorexant in insomnia disorder.

9. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34324636/

Efficacy and Safety of Seltorexant as Adjunctive Therapy in ... Seltorexant, a selective antagonist of human orexin-2 receptors, demonstrated antidepressant effects in a previous exploratory study in patients with major ...