Aticaprant + Antidepressant for Depression
(VENTURA-5 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The purpose of this study is to assess how well aticaprant works compared to placebo when given in addition to antidepressant therapy (selective serotonin reuptake inhibitor \[SSRI\] or serotonin-norepinephrine reuptake inhibitor \[SNRI\]) in preventing return of depression symptoms in participants with major depressive disorder who experience a loss of interest and pleasure and who achieve a stable response after treatment with adjunctive aticaprant.
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop your current medications, but it involves taking aticaprant in addition to your current antidepressant (SSRI or SNRI). It seems you will continue your existing antidepressant therapy while participating.
How does the drug Aticaprant + Antidepressant for Depression differ from other treatments for depression?
The treatment combines Aticaprant, a novel drug, with traditional antidepressants, potentially offering a unique mechanism of action by targeting different pathways in the brain compared to standard antidepressants alone. This combination may provide enhanced efficacy for patients who do not respond adequately to existing antidepressant therapies.12345
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?
This trial is for adults with Major Depressive Disorder who still feel a loss of interest and pleasure despite being on antidepressants. They should have had some improvement with aticaprant added to their treatment. People can't join if they have other mental health conditions, are pregnant or breastfeeding, or are at risk of suicide.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Open-label Treatment
Participants receive open-label treatment with adjunctive aticaprant to achieve a stable response
Double-blind Treatment Maintenance
Participants are randomized to receive either aticaprant or placebo in addition to their antidepressant therapy to prevent relapse
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Aticaprant
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