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Aticaprant

Clinical trials are investigating Aticaprant in people with major depressive disorder, including those with moderate-to-severe anhedonia. These studies look at whether Aticaprant can help improve depressive symptoms, prevent relapse, and assess long-term safety when used with antidepressants.

Table of Contents

Clinical trial overview

Aticaprant was studied in four interventional trials, and all were completed.[1][2][3][4] Most trials focused on major depressive disorder (MDD), especially in adults with moderate-to-severe anhedonia, which means a strong loss of interest or pleasure.[1][2]

Phase 3 studies in major depressive disorder

Three studies were in Phase 3, which is a late stage of research that usually tests whether a treatment works and how safe it is in a larger group of people.[1][2][3]

One phase 3 trial studied Aticaprant as adjunctive therapy, meaning it was added to a current antidepressant, in adults with MDD and moderate-to-severe anhedonia who had an inadequate response to an SSRI or SNRI.[2] This study compared Aticaprant 10 mg with placebo and measured change in the MADRS depression score from baseline to Day 43.[2]

Another phase 3 trial studied Aticaprant plus an antidepressant for relapse prevention in adults with MDD and moderate-to-severe anhedonia who had already achieved a stable response.[1] The main goal was to see how long it took before a relapse event happened during the maintenance phase.[1]

A third phase 3 study looked at the long-term safety and tolerability of Aticaprant when added to a current antidepressant in people with MDD.[3] This study followed participants for up to one year and included an open-label extension, which means some participants could continue treatment in a part of the study where the treatment was known rather than blinded.[3]

Phase 1 study in healthy adults

One Phase 1 study enrolled healthy adult participants, not people with depression.[4] The purpose was to evaluate the absolute bioavailability and metabolic profile of Aticaprant, which means how much of the drug reaches the body and how it is processed after taking it by mouth and by intravenous infusion.[4]

This study was small, with 10 participants, and it used oral Aticaprant together with a microdose intravenous infusion.[4]

Main endpoints and safety measures

The phase 3 relapse-prevention study measured the time from randomization to the first documented relapse event.[1] This endpoint helps show whether the treatment can keep symptoms from returning for longer.[1]

The phase 3 symptom-improvement study measured change in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score from baseline to Day 43.[2] A change in this score helps show whether depression symptoms got better or worse during the study.[2]

The long-term safety study tracked several safety outcomes, including adverse events, vital signs, weight and body mass index, suicidality using the Columbia Suicidality Severity Rating Scale (C-SSRS), laboratory tests, 12-lead ECG, withdrawal symptoms using the Physician Withdrawal Checklist (PWC-20), and sexual function using the Arizona Sexual Experiences Scale (ASEX).[3]

The healthy adult study measured absolute bioavailability (Fabs) as its primary outcome.[4]

Who took part in the studies

The phase 3 studies enrolled adults with MDD, and two of them specifically required moderate-to-severe anhedonia.[1][2][3] One study also required an inadequate response to current antidepressant therapy with an SSRI or SNRI.[2]

The relapse-prevention study focused on adults who had already achieved a stable response before entering the maintenance phase.[1] The phase 1 study was different because it included healthy adults rather than people with depression.[4]

What the trial program shows

The Aticaprant trial program is centered on depression research, especially MDD with anhedonia.[1][2] The main questions were whether Aticaprant could improve symptoms, help prevent relapse, and remain safe when used with antidepressants.[1][2][3]

In healthy volunteers, the research also asked how the body absorbs and processes Aticaprant.[4] Together, these studies provide a clinical picture of Aticaprant research across early and late development stages.[1][2][3][4]

Trial IDPhaseCondition studiedStatusEnrollment
2024-511057-22-00Phase 3MDD with moderate-to-severe anhedoniaCompleted660
2024-511557-21-00Phase 3MDD with moderate-to-severe anhedonia and inadequate response to antidepressant therapyCompleted362
2023-508163-74-00Phase 3Major depressive disorderCompleted1067
2022-502969-19-00Phase 1Healthy adult participantsCompleted10

FAQ

  • What conditions are being studied with Aticaprant? The trials study major depressive disorder, especially when it includes moderate-to-severe anhedonia. One study also included healthy adults to measure how the body handles the drug.
  • Who can join Aticaprant trials? Most studies enrolled adults with major depressive disorder and anhedonia who were already taking an SSRI or SNRI antidepressant. One phase 1 study enrolled healthy adult participants.
  • What are the main goals of these trials? The trials aim to test whether Aticaprant helps improve depression symptoms, delay relapse, and stay safe over time. The healthy volunteer study focused on bioavailability, which means how much of the drug reaches the body after dosing.
  • What phases are the Aticaprant trials in? The studies include phase 1 and phase 3 trials. Phase 1 looked at drug handling in healthy adults, while phase 3 studies tested efficacy, safety, and relapse prevention in people with depression.
  • What outcomes did the trials measure? The trials measured relapse time, changes in depression scores, and safety measures such as vital signs, lab tests, ECG results, weight, suicidality, withdrawal symptoms, and sexual function. These outcomes help show both benefit and possible risks during the study.

Ongoing Clinical Trials on Aticaprant

  • Study on the Safety and Effectiveness of Aticaprant with Antidepressants for Adults and Elderly with Major Depressive Disorder

    Not recruiting

    1 1 1
    Investigated drugs:
    Belgium Bulgaria Czechia France Hungary Italy +5

  • Study on Aticaprant and Antidepressant for Preventing Relapse in Adults with Major Depressive Disorder and Anhedonia

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Bulgaria Czechia France Germany Greece +3

  • Study on Aticaprant for Adults with Major Depressive Disorder and Anhedonia Not Responding to Antidepressants

    Not recruiting

    1 1
    Investigated drugs:
    Belgium Bulgaria Czechia Finland Hungary Poland +2

Glossary

  • Major Depressive Disorder (MDD): A medical condition with ongoing low mood and loss of interest or pleasure that affects daily life.
  • Anhedonia: A reduced ability to feel pleasure from activities that were once enjoyable.
  • Adjunctive therapy: A treatment given together with another treatment, such as a drug added to an antidepressant.
  • SSRI: A common type of antidepressant. The full name is selective serotonin reuptake inhibitor.
  • SNRI: A common type of antidepressant. The full name is serotonin-norepinephrine reuptake inhibitor.
  • Relapse: A return of symptoms after they had improved.
  • Randomized: Participants are assigned to treatment groups by chance.
  • Double-blind: Neither the participants nor the study team know who receives the study drug or placebo during the blinded part of the trial.
  • Placebo: An inactive treatment that looks like the study drug.
  • Montgomery-Åsberg Depression Rating Scale (MADRS): A questionnaire used to measure how severe depression symptoms are.
  • Electrocardiogram (ECG): A test that records the heart's electrical activity.
  • Bioavailability: How much of a drug gets into the body and becomes available to work after it is given.

References

  1. https://clinicaltrials.gov/study/2024-511057-22-00
  2. https://clinicaltrials.gov/study/2024-511557-21-00
  3. https://clinicaltrials.gov/study/2023-508163-74-00
  4. https://clinicaltrials.gov/study/2022-502969-19-00