Aticaprant for Depression

(VENTURA-LT Trial)

Recruiting at 219 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: Noncompliance, Allergies to aticaprant, others

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

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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: 52 weeks

840 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing if adding aticaprant to current antidepressants is safe and well-tolerated in people with major depressive disorder. The goal is to see if it can help improve their treatment.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but it does mention that participants should not take any prohibited medication or food supplements. You can continue taking your current antidepressant (SSRI or SNRI) as aticaprant is used as an additional treatment.

How does the drug Aticaprant differ from other depression treatments?

Aticaprant is unique because it is a neurokinin-1 (NK1) receptor antagonist, which is a different mechanism of action compared to most traditional antidepressants. While it was initially used to prevent nausea and vomiting from chemotherapy, its potential antidepressant effects are being explored, setting it apart from standard treatments like SSRIs (selective serotonin reuptake inhibitors). ^{1 2 3 4 5}

Research Team

Janssen Research & Development, LLC Clinical trial

Principal Investigator

Janssen Research & Development, LLC

Eligibility Criteria

This trial is for adults with Major Depressive Disorder who haven't had enough improvement after trying 1-3 antidepressants. They must have a certain score on a depression rating scale and meet specific diagnostic criteria without psychotic features. Employees of the study or those with allergies to aticaprant can't participate.

Inclusion Criteria

Have you tried at least 1 antidepressant that hasn't worked?

Have you been diagnosed with Depression?

Are you currently on a Neurotransmitter Uptake Inhibitor?

Exclusion Criteria

Have you tried more than 2 antidepressants that haven't worked?

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Aticaprant 10 mg once daily, orally in addition to their current antidepressant therapy

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Open-label extension

Participants may continue to receive Aticaprant as adjunctive therapy to assess long-term safety and efficacy

Long-term

Treatment Details

Interventions

• Aticaprant

Trial Overview The trial tests Aticaprant's long-term safety and effectiveness when added to current SSRI or SNRI treatments in patients with depression. It aims to see if this combination helps people who didn't respond well to previous medications.

Participant Groups

Group I: Aticaprant 10 mg Experimental Treatment 1 Intervention

Participants will enter this study directly or after completing double-blind phase of studies 67953964MDD3001 or 67953964MDD3002 and will receive Aticaprant 10 milligrams (mg), once daily, orally in addition to the current antidepressant selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor (SSRI/SNRI) therapy on Day 1 up to 52 weeks.

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

Findings from Research

In a phase 2 study involving 236 outpatients with major depressive disorder, the combination of aprepitant and paroxetine did not show a significant improvement in depression scores compared to paroxetine alone after 6 weeks.

Patients taking the combination therapy experienced more adverse events than those on monotherapy, indicating that adding aprepitant may not be beneficial and could increase side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Addition of an NK1 receptor antagonist to an SSRI did not enhance the antidepressant effects of SSRI monotherapy: results from a randomized clinical trial in patients with major depressive disorder. Ball, WA., Snavely, DB., Hargreaves, RJ., et al.[2022]

In a randomized trial comparing 5 mg olanzapine and aprepitant for preventing chemotherapy-induced nausea and vomiting (CINV) in patients receiving cisplatin, both medications showed similar effectiveness in total protection rates during acute, delayed, and overall phases, with no significant differences in outcomes.

While both treatments were effective, olanzapine was associated with increased sedation as a side effect, while aprepitant led to constipation, suggesting that olanzapine may offer a cost-effective alternative for managing CINV despite its sedative effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Comparison of the Efficacy of 5 mg Olanzapine and Aprepitant in the Prevention of Multiple-Day Cisplatin Chemotherapy-Induced Nausea and Vomiting. Liu, G., Jin, Y., Jiang, Y., et al.[2022]

Aprepitant, the first NK1 receptor antagonist approved for preventing chemotherapy-induced nausea and vomiting (CINV), is effective with a dosing regimen of 125 mg on day 1 and 80 mg on days 2 and 3, showing consistent plasma levels and good tolerability.

The bioavailability of aprepitant is not significantly affected by food intake, allowing it to be taken independently of meals, which simplifies its administration for patients undergoing chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetics of aprepitant after single and multiple oral doses in healthy volunteers. Majumdar, AK., Howard, L., Goldberg, MR., et al.[2018]

In a phase 3 trial involving 196 patients receiving carboplatin, the fixed antiemetic combination NEPA (netupitant and palonosetron) demonstrated similar efficacy to the standard regimen of aprepitant, palonosetron, and dexamethasone in preventing nausea and vomiting, with complete response rates ranging from 80% to 93%.

Both NEPA and aprepitant showed comparable rates of no significant nausea, suggesting that NEPA is an effective alternative for managing chemotherapy-induced nausea and vomiting in carboplatin-treated patients, supporting the recommendation for NK1 receptor antagonists in treatment guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy benefit of an NK1 receptor antagonist (NK1RA) in patients receiving carboplatin: supportive evidence with NEPA (a fixed combination of the NK1 RA, netupitant, and palonosetron) and aprepitant regimens. Jordan, K., Gralla, R., Rizzi, G., et al.[2018]

Aprepitant, an NK1 receptor antagonist, significantly improves the prevention of chemotherapy-induced nausea and vomiting (CINV) when added to standard antiemetic therapy, with complete response rates increasing from 43.3%-52.3% to 58.8%-71% in clinical trials involving multiple cycles of highly emetogenic chemotherapy.

The addition of aprepitant is well tolerated, with adverse events similar to standard therapy, and it effectively reduces the impact of CINV on patients' daily lives, making it a valuable option for patients undergoing chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antiemetic studies on the NK1 receptor antagonist aprepitant. Stoutenburg, JP., Raftopoulos, H.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

Addition of an NK1 receptor antagonist to an SSRI did not enhance the antidepressant effects of SSRI monotherapy: results from a randomized clinical trial in patients with major depressive disorder. [2022]

2. India pubmed.ncbi.nlm.nih.gov

A Comparison of the Efficacy of 5 mg Olanzapine and Aprepitant in the Prevention of Multiple-Day Cisplatin Chemotherapy-Induced Nausea and Vomiting. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Pharmacokinetics of aprepitant after single and multiple oral doses in healthy volunteers. [2018]

4. Germany pubmed.ncbi.nlm.nih.gov

Efficacy benefit of an NK1 receptor antagonist (NK1RA) in patients receiving carboplatin: supportive evidence with NEPA (a fixed combination of the NK1 RA, netupitant, and palonosetron) and aprepitant regimens. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Antiemetic studies on the NK1 receptor antagonist aprepitant. [2019]