Aticaprant for Major Depressive Disorder

(VENTURA-1 Trial)

No longer recruiting at 199 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests aticaprant as an additional treatment to improve symptoms of major depressive disorder (MDD) in individuals already taking antidepressants but still experiencing moderate-to-severe lack of interest or pleasure (anhedonia). It compares the effects of aticaprant to a placebo, both administered alongside the participant’s current antidepressant. Suitable candidates for this trial include those who have been taking an SSRI or SNRI antidepressant for at least six weeks but still find their depression isn't improving enough. As a Phase 3 trial, this study serves as the final step before potential FDA approval, offering participants a chance to contribute to a treatment that could soon become widely available.

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.

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

Research has shown that aticaprant is usually well-tolerated. Studies have found that when combined with antidepressants, most people experience only mild side effects. No major safety issues have been reported so far. This suggests that aticaprant could safely complement current treatments for major depressive disorder. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for major depressive disorder?

Aticaprant is unique because it targets the kappa opioid receptor, offering a different approach than the typical antidepressants like SSRIs or SNRIs, which focus on serotonin and norepinephrine. This mechanism is thought to help alleviate symptoms of major depressive disorder in a novel way, potentially addressing cases where current treatments fall short. Researchers are excited about aticaprant because it might provide faster relief and benefit those who don't respond well to existing medications.

What evidence suggests that aticaprant might be an effective treatment for major depressive disorder?

Research has shown that aticaprant, which participants in this trial may receive, may help treat major depressive disorder (MDD), especially for those who haven't found success with some antidepressants. Studies found that adding aticaprant to current antidepressant treatments significantly reduced depressive symptoms, improving mood and motivation. Aticaprant blocks certain brain receptors involved in mood control. It is generally well-tolerated, with only mild side effects reported. ^{1 2 3 4 5}

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?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

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/38649428/

Efficacy and safety of aticaprant, a kappa receptor ... In this study of participants with MDD and inadequate response to SSRI/SNRI, adjunctive treatment with aticaprant significantly reduced depressive symptoms ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06514742

NCT06514742 | A Study of Aticaprant 10 mg as Adjunctive ... The purpose of this study is to evaluate how well aticaprant works as compared with placebo when given along with an antidepressant therapy in improving the ...

3. tandfonline.com tandfonline.com/doi/full/10.1080/14728214.2024.2345645

Full article: Aticaprant: (a κ-opioid receptor antagonist) for ... ... effects beyond major depressive disorder (MDD) treatment. Furthermore, the authors found Aticaprant to possess good tolerability and a low side-effect profile.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165032724010863

Preclinical and clinical efficacy of kappa opioid receptor ... Aticaprant and navacaprant reduced depressive symptoms in persons with MDD. •. Treatment-emergent adverse events were mild in severity and ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38969753/

Aticaprant, a kappa opioid receptor antagonist, and the ... Mounting evidence supports the potential of kappa-opioid receptor (KOR) antagonists as novel pharmacotherapies for major depressive disorder : ...