Seltorexant for Depression

No longer recruiting at 27 trial locations

Overseen By Study Contact

Age: < 18

Sex: Any

Trial Phase: Phase 1

Sponsor: Janssen Research & Development, LLC

Must be taking: Antidepressants

Disqualifiers: Liver, Renal, Cardiac, Psychiatric, others

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

Compensation: Varies

Number of Visits: 1

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called Seltorexant (also known as JNJ-42847922, MIN-202, or JNJ-7922) to determine its safety and tolerability when added to antidepressants for adolescents with major depressive disorder (MDD). Participants will receive either Seltorexant or a placebo while continuing their current antidepressant, such as Fluoxetine or Escitalopram, for six weeks. The trial seeks teens who have tried antidepressants but still experience significant depression symptoms. As a Phase 1 trial, this research aims to understand how Seltorexant works in people, offering participants the chance to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions that participants must have an inadequate response to their current antidepressant, either fluoxetine or escitalopram, to be eligible. This suggests you may continue taking your current antidepressant during the trial.

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

Research has shown that Seltorexant is generally well-tolerated. In studies, it was used with other antidepressants and caused fewer side effects compared to similar treatments. One study found that Seltorexant was safe, with the most common side effects appearing similarly in both the treatment and placebo groups. This suggests the treatment might not cause many unexpected problems.

In another study on insomnia, Seltorexant helped people fall asleep and was well-tolerated. Its current testing in a Phase 1 trial indicates that more information is needed about its safety in humans. However, existing research presents a hopeful picture of Seltorexant's safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for depression?

Seltorexant is unique because it targets the orexin system, which is a different approach compared to most standard antidepressants like SSRIs that primarily focus on serotonin. Researchers are excited about seltorexant because it has the potential to improve sleep disturbances often associated with depression, addressing both mood and sleep issues simultaneously. This dual action could make it a promising option for those who don't fully respond to current treatments.

What evidence suggests that Seltorexant might be an effective treatment for depression?

Research has shown that seltorexant, which participants in this trial may receive, may help treat depression. In earlier studies, people taking seltorexant experienced significant improvements in their depression symptoms, especially when combined with regular antidepressants like SSRIs. One study found that after just ten days of taking seltorexant, participants showed a noticeable reduction in key depression symptoms. These findings suggest that seltorexant could be an effective additional treatment for people with depression. ^{1 3 4 5 6}

Who Is on the Research Team?

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Are You a Good Fit for This Trial?

Adolescents with major depressive disorder who haven't improved after trying one or two SSRI antidepressants and psychotherapy can join this trial. They must have a certain level of depression severity, weigh between the fifth and ninety-fifth percentile for their age unless medically cleared, and girls able to have children need a negative pregnancy test.

Inclusion Criteria

I have received enough mental health support for my current depression.

My weight is within the normal range for my age and sex, or I have medical clearance if not.

My depression hasn't improved much after trying 1 or 2 antidepressants, including fluoxetine or escitalopram.

Exclusion Criteria

I have a sleep disorder, but it's not severe like sleep apnea.

I have a stable mental health condition but not major depression caused by it, or bipolar disorder.

I have stable health conditions despite having a history of significant health issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to 4 weeks

Treatment

Participants receive Seltorexant or placebo as adjunctive therapy to antidepressants for 6 weeks

6 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including a telephone consult and on-site follow-up visit

2 weeks

1 visit (in-person), 1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Seltorexant

Trial Overview The study is testing Seltorexant as an additional treatment alongside an antidepressant compared to a placebo (a pill without active medication). The goal is to see if it's safe and helps improve symptoms in young people with depression more than just the antidepressant alone.

How Is the Trial Designed?

Group I: Seltorexant Experimental Treatment 1 Intervention

Participants will receive weight based dose of Seltorexant orally once daily from Day 1 to Day 42 (until the end of Week 6). Participants will continue baseline selective serotonin reuptake inhibitor (SSRI) antidepressant (Fluoxetine or escitalopram) orally once daily.

Group II: Placebo Placebo Group 1 Intervention

Participants will receive matching placebo tablets to seltorexant orally once daily from Day 1 to Day 42 (until the end of Week 6).

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. 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 ...

2. 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 ...

3. 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 ...

4. 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, ...

5. 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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12351464/

Efficacy and Safety of Seltorexant in Insomnia Disorder Seltorexant, 10 mg and 20 mg, demonstrated efficacy in the initiation of sleep in participants with insomnia without psychiatric comorbidity.