Aticaprant for Depression
(VENTURA-LT Trial)
Recruiting in Palo Alto (17 mi)
+219 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Janssen Research & Development, LLC
Must be taking: SSRIs, SNRIs
Disqualifiers: Noncompliance, Allergies to aticaprant, others
Stay on Your Current Meds
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
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).
12345Eligibility 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?
Trial 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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Aticaprant 10 mgExperimental Treatment1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
The University of British ColumbiaVancouver, Canada
Okanagan Clinical TrialsKelowna, Canada
St. Michael's HospitalToronto, Canada
Clarke Institute of PsychiatryToronto, Canada
More Trial Locations
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Who Is Running the Clinical Trial?
Janssen Research & Development, LLCLead Sponsor
References
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]Aprepitant is a neurokinin 1 receptor antagonist approved for prevention of chemotherapy-induced and post-operative nausea and vomiting. Early studies demonstrated promising antidepressant activity as monotherapy, although this was unsupported by subsequent phase 3 trials. This phase 2 study evaluated whether aprepitant potentiated the antidepressant effects of paroxetine.
A Comparison of the Efficacy of 5 mg Olanzapine and Aprepitant in the Prevention of Multiple-Day Cisplatin Chemotherapy-Induced Nausea and Vomiting. [2022]The significance of this article is to talk about aprepitant and olanzapine 5 mg, compare them, and deeply explore the safety or effectiveness during the whole process of multiple-day cisplatin chemotherapy-induced vomiting and nausea.
Pharmacokinetics of aprepitant after single and multiple oral doses in healthy volunteers. [2018]Aprepitant is the first NK1 receptor antagonist approved for use with corticosteroids and 5HT3 receptor antagonists to prevent chemotherapy-induced nausea and vomiting (CINV). The effective dose to prevent CINV is a 125-mg capsule on day 1 followed by an 80-mg capsule on days 2 and 3. Study 1 evaluated the bioavailability of the capsules and estimated the effect of food. The mean (95% confidence interval [CI]) bioavailabilities of 125-mg and 80-mg final market composition (FMC) capsules, as assessed by simultaneous administration of stable isotope-labeled intravenous (i.v.) aprepitant (2 mg) and FMC capsules, were 0.59 (0.53, 0.65) and 0.67 (0.62, 0.73), respectively. The geometric mean (90% CI) area under the plasma concentration time curve (AUC) ratios (fed/fasted) were 1.2 (1.10, 1.30) and 1.09 (1.00, 1.18) for the 125-mg and 80-mg capsule, respectively, demonstrating that aprepitant can be administered independently of food. Study 2 defined the pharmacokinetics of aprepitant administered following the 3-day regimen recommended to prevent CINV (125 mg/80 mg/80 mg). Consistent daily plasma exposures of aprepitant were obtained following this regimen, which was generally well tolerated.
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]Antiemetic guideline recommendations are inconsistent as to whether a neurokinin-1 receptor antagonist (NK1 RA) should be administered with a 5-hydroxytryptamine-3 (5HT3) RA + dexamethasone (DEX) in patients receiving carboplatin. Patients receiving cisplatin routinely receive an NK1 RA-containing regimen with a resulting 14-22 % benefit in no emesis rates over a 5-HT3 RA/DEX control. Recent studies suggest a similar benefit in patients receiving carboplatin. NEPA is the first fixed antiemetic combination agent and comprises the highly selective NK1 RA, netupitant, and pharmacologically distinct 5-HT3 RA, palonosetron (PALO). This paper presents the efficacy of NEPA in the subset of patients receiving carboplatin in a phase 3 trial (NCT01376297), in the context of aprepitant (APR) data in the carboplatin setting.
Antiemetic studies on the NK1 receptor antagonist aprepitant. [2019]Aprepitant (Emend, Merck Inc., Whitehouse Station, NJ), a neurokin-1 (NK1) receptor antagonist, is a first-in-class agent approved for the prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV). It competitively binds to NK1 receptors, blocks the binding of substance P, the natural ligand, and prevents signal transduction. Early clinical trials showed that aprepitant combined with standard therapy (corticosteroids and serotonin receptor antagonists) provided improved antiemetic protection in patients receiving highly emetogenic chemotherapy. The results of three randomized, double blind, placebo-controlled trialsthat compared aprepitant plus standard therapy with standard therapy plus placebo showed significant improvements in complete response rates (defined as no emesis and no use of rescue medication) with the addition of aprepitant (58.8% to 71% vs. 43.3% to 52.3%; P