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Clinical trials

Janssen posts results of long-term aticaprant study in 871 participants

Janssen posted results of the open-label VENTURA-LT study of aticaprant in major depressive disorder on 2026-10-06. The study enrolled 871 participants and ended early, and the record says the results have limited interpretive value.

By The Priority Review desk

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Janssen Research & Development, LLC posted results of VENTURA-LT, an open-label, long-term study of aticaprant in major depressive disorder (MDD), on 2026-10-06, according to the study record in the public trial registry. The record lists 871 participants. The study began on 2022-09-22 and reached primary completion on 2025-04-25. The record lists its status as TERMINATED and gives the reason: “The study was Early Terminated as per Sponsor's decision.”

Study design and population

The official title is “An Open-label, Long-term, Safety and Efficacy Study of Aticaprant as Adjunctive Therapy in Adult and Elderly Participants With Major Depressive Disorder (MDD).” The record lists the phase as PHASE3, with a single group and no masking. The sponsor is Janssen Research & Development, LLC.

Participants took aticaprant 10 mg, a tablet taken orally once daily, for up to 52 weeks. Participants took it in addition to a current antidepressant, either a selective serotonin reuptake inhibitor (SSRI) or a serotonin and norepinephrine reuptake inhibitor (SNRI). Participants who completed the open-label treatment phase at Week 52 were followed up for safety for 2 weeks, up to Week 54.

The record says the purpose is to assess the long-term safety and tolerability of aticaprant as adjunctive therapy to a current antidepressant in all participants with MDD. Participants entered in one of two ways. Transferred-entry participants completed the double-blind phase of one of two parent studies. The record names the parent studies as NCT05455684 and NCT05550532. Direct-entry participants entered the study directly.

Direct-entry participants needed a Hamilton Depression Rating Scale (HDRS)-17 total score of 20 or higher at the first and second screening interviews. These participants also needed an inadequate response to at least 1 oral antidepressant treatment at an adequate dose and duration, at least 6 weeks, in the current episode of depression. The record lists a minimum age of 18 Years and a maximum age of 74 Years. The record lists sites in the United States, Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, China, Czechia, France, Hungary, Italy and other countries.

Safety and tolerability measures

The record lists safety measures as primary outcomes. The measures include the number of participants with treatment-emergent adverse events (TEAEs) and adverse events of special interest up to Week 52, and adverse events from Week 52 to Week 54. The measures also include changes from baseline in blood pressure, pulse rate, temperature, weight, body mass index, laboratory parameters and ECG parameters.

The other primary outcomes cover suicidal ideation or behavior on the Columbia Suicidality Severity Rating Scale (C-SSRS), withdrawal symptoms on the Physician Withdrawal Checklist 20-item (PWC-20), and sexual dysfunction on the Arizona Sexual Experiences Scale (ASEX).

The record lists, for the ASEX, 846 participants evaluable and a value of 72.1 for the percentage with clinically relevant sexual dysfunction over time, at any time from Week 12 to Week 52. The record defines sexual dysfunction as an ASEX total score of 19 or greater, a score of 5 or greater on any item, or a score of 4 or greater on any 3 items.

Safety analysis set and adverse events

The adverse event tables list 870 participants at risk in the open-label treatment phase. The record lists 1 death, serious adverse events in 29 participants and other adverse events in 163 participants. The record sets a frequency threshold of 5 for other adverse events.

The record lists these serious adverse events: Completed Suicide in 1 participant, Suicidal Ideation in 2, Depression in 3, Intentional Overdose in 2 and Pneumonia in 2. The record lists these other adverse events: Pruritus in 72 participants, Headache in 61 and Nasopharyngitis in 52.

The record lists, for the follow-up phase, 748 participants at risk, with 0 deaths, serious adverse events in 1 participant and other adverse events in 3 participants.

Change From Baseline in ANH+ participants

The record also lists secondary outcomes. These outcomes use the full analysis set with prominent anhedonia (ANH+), which includes adult participants with MDD ANH+ who took at least 1 dose of study treatment.

The record lists these results at the open-label assessment, any time from Week 4 or Week 12 to Week 52, and at follow-up:

  • Montgomery-Asberg Depression Rating Scale (MADRS) total score, change from baseline: -7.1 (standard deviation 12.40) in 609 participants, and -7.4 (12.97) in 525 at follow-up. The record says a negative change indicates improvement.
  • Patient Health Questionnaire, 9-item (PHQ-9) total score, change from baseline: -3.2 (7.15) in 594 participants, and -3.4 (7.45) in 503 at follow-up.
  • Dimensional Anhedonia Rating Scale (DARS) total score, change from baseline: 9.1 (18.35) in 600 participants, and 8.5 (19.38) in 498 at follow-up. The record says a positive change indicates improvement.
  • Clinical Global Impression-Severity (CGI-S) score, change from baseline: -0.9 (1.48) in 609 participants, and -0.9 (1.54) in 525 at follow-up.
  • Percentage with a 50 percent or greater reduction in MADRS total score: 55.2 at the open-label assessment and 57.0 at follow-up.
  • Percentage with remission, a MADRS total score of 10 or less: 43.8 at the open-label assessment and 44.6 at follow-up.

Early termination and publication terms

The record includes this statement from the sponsor: “Due to early termination of this study, fewer participants were enrolled than was originally planned. Therefore, the results were considered to have limited interpretive value.”

The record lists the results as first submitted on 2026-04-22, with quality control on 2026-09-14. It lists a study protocol dated 2023-02-22 and a statistical analysis plan dated 2024-10-21.

The record also lists a restrictive agreement. If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. The record does not describe a further study of aticaprant.

Sources