Aticaprant for Major Depressive Disorder

(VENTURA-1 Trial)

Recruiting at 170 trial locations

Overseen By Study Contact

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Janssen Research & Development, LLC

Must be taking: SSRIs, SNRIs

Disqualifiers: Substance use disorder, Seizures, Suicidal ideation, 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

Duration: 6 weeks

513 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing aticaprant to see if it can help people with major depressive disorder who still feel very down and don't enjoy things despite taking other antidepressants. The study focuses on adults who haven't responded well to their current treatments. Aticaprant works by blocking a specific brain receptor, which might help improve their mood and reduce depressive symptoms.

Will I have to stop taking my current medications?

No, you will not have to stop taking your current medications. The trial requires participants to continue their current SSRI or SNRI antidepressant at a stable dose.

Research Team

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Eligibility Criteria

Adults with major depressive disorder and moderate-to-severe anhedonia not responding well to current SSRI or SNRI antidepressants. They must have been on a stable dose for at least 6 weeks, have no history of seizures or recent suicidal behavior, and cannot have certain other mental health diagnoses like bipolar disorder or substance use disorders.

Inclusion Criteria

My current depression and its treatment response are confirmed by an independent assessment.

Your depression score is 20 or higher and does not improve between two screenings.

I am taking and handling an SSRI or SNRI medication well for depression.

Exclusion Criteria

You have had thoughts of hurting yourself or others within the past 3 months or have a history of attempting to hurt yourself within the past 6 months.

You have a history of not following your prescribed antidepressant treatment.

My current treatment with ketamine, ECT, VNS, or DBS hasn't worked well.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

Up to 4 weeks

Treatment

Participants receive aticaprant or placebo orally once daily for 42 days in addition to their current antidepressant therapy

6 weeks

Regular visits for safety evaluations and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Open-label extension (optional)

Participants may opt into a separate 52-week open-label long-term safety study

52 weeks

Treatment Details

Interventions

• Aticaprant

Trial Overview The trial is testing Aticaprant as an add-on treatment to see if it improves symptoms in patients who haven't responded enough to their current antidepressant therapy. Participants will either receive Aticaprant or a placebo alongside their usual medication.

Participant Groups

Group I: Aticaprant Experimental Treatment 1 Intervention

Participants will receive aticaprant tablets orally once daily for 42 days during double-blind treatment phase in addition to the current antidepressant selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor (SSRI/SNRI) therapy. Participants who will complete the double-blind treatment phase (Day 43) may be eligible to participate in a separate 52-week open-label long-term safety study (67953964MDD3003).

Group II: Placebo Placebo Group 1 Intervention

Participants will receive matching placebo orally once daily for 42 days during double-blind treatment phase in addition to their current antidepressant (SSRI/SNRI) therapy. Participants who will complete the double-blind treatment phase (Day 43) may be eligible to participate in a separate 52-week open-label long-term safety study (67953964MDD3003).

Who Is Running the Clinical Trial?

Janssen Research & Development, LLC

Lead Sponsor

Trials

1,022

Recruited

6,408,000+

Giacomo Salvadore

Janssen Research & Development, LLC

Chief Medical Officer since 2023

MD from the University of Rome, Tor Vergata

Ricardo Attar

Janssen Research & Development, LLC

Chief Executive Officer since 2008

PhD in Molecular Biology from the University of Buenos Aires