Esketamine for Major Depressive Disorder
(AVENUE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests how well esketamine quickly reduces severe depression symptoms in adolescents experiencing suicidal thoughts or behaviors. Participants will receive either esketamine (a nasal spray medication) or a placebo (a harmless substance) alongside their usual depression care. It targets teens diagnosed with major depressive disorder who struggle with severe suicidal feelings and need immediate help. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that using esketamine as a nasal spray is generally safe. Studies conducted over many months have confirmed its safety, with headaches being the most common side effect. Real-world studies, where people used esketamine for nearly five years, also found it remains safe over time.
Some individuals might experience mild side effects like dizziness or nausea. The FDA has approved esketamine for treating other types of depression, indicating its safety for humans. However, those considering joining a trial should consult a doctor about any concerns.12345Why do researchers think this study treatment might be promising?
Unlike the standard antidepressants, which often take weeks to take effect and typically work by altering serotonin levels, esketamine offers a new approach by targeting the NMDA receptors in the brain. This unique mechanism can lead to rapid mood improvements, sometimes within hours, which is particularly promising for those with treatment-resistant depression. Additionally, esketamine is administered intranasally, offering a quick and non-invasive delivery method compared to traditional oral medications. Researchers are excited about esketamine's potential to provide faster relief for patients with major depressive disorder who haven't responded to conventional treatments.
What evidence suggests that esketamine might be an effective treatment for major depressive disorder?
Research shows that a nasal spray called esketamine, which participants in this trial may receive, can help treat major depressive disorder (MDD). Studies have found that it reduces depression symptoms, especially for those unresponsive to other treatments. In one study, patients showed significant improvements in their depression scores, indicating that esketamine might provide relief. Another study found that esketamine also enhanced users' quality of life and productivity. These findings suggest that esketamine could be a valuable option for treating depression.45678
Are You a Good Fit for This Trial?
This trial is for adolescents with severe symptoms of Major Depressive Disorder (MDD) who are experiencing acute suicidal thoughts or behaviors. They must have specific scores on depression and suicidality scales, require hospitalization due to their condition, be medically stable, and meet the DSM-5 criteria for MDD.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive intranasal esketamine or placebo twice weekly for 4 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Esketamine
Trial Overview
The study tests if Esketamine can quickly reduce symptoms of MDD when added to standard care compared to a psychoactive placebo plus standard care. Participants will receive either Esketamine or placebo through nasal spray alongside other treatments.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Participants will receive intranasal esketamine 84 milligrams (mg) along with oral placebo solution twice weekly for 4 weeks (Days 1, 4, 8, 11, 15, 18, 22, and 25). On Day 4 a decrease to intranasal esketamine 56 mg (in a blinded fashion per investigator's judgment) is permitted. Thereafter, dose may be flexed between 56 mg and 84 mg during the treatment period.
Participants will receive oral midazolam (0.0625 milligrams per kilograms \[mg/kg\]) and intranasal placebo twice weekly for 4 weeks (Days 1, 4, 8, 11, 15, 18, 22, and 25). On Day 4 a sham decrease to esketamine 56 mg dose (in a blinded fashion per investigator's judgment) is permitted. Thereafter, sham dose may be flexed between 56 mg and 84 mg during the treatment period.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Janssen Research & Development, LLC
Lead Sponsor
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
Intranasal esketamine for patients with major depressive ...
Intranasal esketamine demonstrated effectiveness in reducing scores among patients with MDD and TRD. The drug exhibited both safety and tolerability.
A real-world study examining the impact of esketamine ...
This study describes changes in quality of life, depressive symptoms and productivity in participants treated with esketamine in real-world settings.
Efficacy and Safety of Esketamine Nasal Spray in ...
Primary efficacy outcomes included change in depressive symptoms, response (≥50% reduction), and remission rates. Secondary outcomes were ...
Esketamine Monotherapy in Adults With Treatment ...
Adults with major depressive disorder (DSM-5 criteria) without psychotic features who experienced inadequate response (≤25% improvement) to 2 or ...
NCT07227454 | A Study to Evaluate the Efficacy and ...
The purpose of this study is to evaluate how well JNJ-54135419 works (efficacy) in addition to comprehensive standard of care (SoC) in rapidly ...
TRD Efficacy & Safety
7.9% of patients receiving SPRAVATO® + oral AD achieved response by Day 2 and maintained response by Day 28 vs 4.6% with placebo + oral AD · Mean total SDS score ...
Safety and efficacy with esketamine in treatment-resistant ...
Mean (median, range) exposure to esketamine in SUSTAIN-3 was 42.9 (45.8, range 0-79) months. The most common adverse events were headache (36.9 ...
Real-World Safety of Esketamine Nasal Spray
The objective of this study was to comprehensively examine the real-world safety of esketamine using 58 months of postapproval data in the ...
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