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

Fast replyInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying Major Depressive Disorder (MDD), a condition characterized by persistent feelings of sadness and loss of interest. The study specifically targets individuals with moderate-to-severe anhedonia, which is a reduced ability to feel pleasure. The treatment being tested is a medication called Aticaprant, which is taken in tablet form. It is used alongside an antidepressant, which is a type of medication that helps to relieve symptoms of depression. The purpose of the study is to evaluate how effective Aticaprant is in preventing the return of depressive symptoms in people who have already shown improvement with their current treatment.

Participants in the study will be randomly assigned to receive either Aticaprant or a placebo, which looks like the medication but does not contain the active substance. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo. This helps to ensure that the results are not influenced by expectations about the treatment. The study will take place over a period of time, during which participants will continue their usual antidepressant treatment while also taking the study medication or placebo.

The main goal is to see how long it takes for depressive symptoms to return, if they do, after starting the study treatment. This information will help researchers understand if Aticaprant can effectively delay the relapse of depression symptoms in people with MDD and anhedonia. Participants will be monitored regularly to assess their response to the treatment and to ensure their safety throughout the study.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria, including age, medical stability, and diagnosis of major depressive disorder (MDD) with moderate-to-severe anhedonia.

    A physical examination, medical history review, and laboratory tests are conducted to ensure medical stability.

  2. Step 2

    Screening phase

    During the screening phase, further assessments are conducted to confirm the diagnosis of MDD and symptoms of anhedonia.

    The participant's eligibility is reassessed based on clinical assessments and specific diagnostic criteria.

  3. Step 3

    Randomization

    Participants are randomly assigned to receive either the study medication, aticaprant, or a placebo.

    The study is double-blind, meaning neither the participant nor the study team knows which treatment is being administered.

  4. Step 4

    Treatment phase

    Participants take a 10 mg tablet of aticaprant or a matching placebo once daily.

    This medication is taken in addition to an existing antidepressant, which may be a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI).

  5. Step 5

    Maintenance phase

    The primary goal during this phase is to monitor the time until a relapse of depressive symptoms occurs.

    Regular assessments are conducted to document any changes in symptoms and overall health.

  6. Step 6

    End of study

    The study is estimated to conclude by May 2027.

    Final assessments are conducted to evaluate the overall effectiveness of the treatment in preventing relapse of depressive symptoms.

Who can join the trial?

5 criteria

  • Adults aged 18 to 64 years can participate. This means you must be at least 18 years old and not older than 64.
  • You need to be in good health based on a physical exam, which includes checking your medical history, vital signs like blood pressure, and a heart test called a 12-lead ECG.
  • Your health should also be stable based on lab tests. If any test results are not normal, they can be checked again. You can still join if the doctor thinks the results are not a problem for the study.
  • You must have been diagnosed with **Major Depressive Disorder (MDD)**, which means having episodes of depression, but not with psychotic features. This diagnosis is confirmed by a special interview called the SCID-CT.
  • You should have symptoms of **anhedonia**, which means not finding pleasure in things you used to enjoy. This is confirmed by the SCID-CT interview and a score from a test called SHAPS.

Who cannot join the trial?

5 criteria

  • Patients who do not have a diagnosis of Major Depressive Disorder (MDD) with moderate-to-severe Anhedonia cannot participate. Anhedonia means having a reduced ability to feel pleasure in activities that were once enjoyable.
  • Patients who have not achieved a stable response to their current antidepressant treatment cannot participate. This means their symptoms must be consistently improved with their current medication.
  • Patients who are not taking an antidepressant from the SSRI or SNRI class cannot participate. SSRIs and SNRIs are types of medications used to treat depression.
  • Patients who are not adults cannot participate. This means participants must be 18 years or older.
  • Patients who are part of a vulnerable population cannot participate. Vulnerable populations may include groups like pregnant women or those with certain health conditions.
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Investigated drugs

  • Aticaprant

    is a medication being studied to see if it can help prevent the return of depressive symptoms in people with major depressive disorder (MDD) who have already responded well to treatment. It is used alongside another antidepressant to see if it can provide additional benefits.

  • Antidepressants (SSRI/SNRI)

    are medications commonly used to treat depression. In this study, they are used in combination with aticaprant to see if together they can better prevent the relapse of depressive symptoms in people with MDD.

What is already known about the treatment

Aticaprant – Aticaprant is administered orally in the form of a tablet, taken once daily. It is currently being studied in clinical trials as an adjunctive treatment for Major Depressive Disorder (MDD) with moderate-to-severe anhedonia. The main therapeutic indication is to prevent relapse of depressive symptoms in patients who have already achieved a stable response with standard antidepressants. At the molecular level, aticaprant works by modulating specific receptors in the brain that are involved in mood regulation. It is classified pharmacologically as a kappa opioid receptor antagonist.

Investigated diseases

Major Depressive Disorder (MDD) with Moderate-to-severe Anhedonia – This is a mental health condition characterized by persistent feelings of sadness, hopelessness, and a lack of interest or pleasure in activities that were once enjoyable. Anhedonia, a core symptom, refers to the reduced ability to experience pleasure. The disorder can lead to significant impairment in daily functioning, affecting work, relationships, and overall quality of life. Symptoms may include changes in appetite, sleep disturbances, fatigue, and difficulty concentrating. The progression of the disorder can vary, with some individuals experiencing episodes that last for weeks or months. It is a common condition that can affect people of all ages.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-511057-22-00Protocol code67953964MDD3005Estimated enrolment660 patientsSponsorJanssen Cilag International

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).