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

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, and who have not responded adequately to their current antidepressant treatments. The trial will test a new medication called Aticaprant, which is taken as a tablet, to see if it can help improve symptoms when used alongside existing antidepressant medications.

The purpose of the study is to evaluate how effective and safe Aticaprant is in improving depressive symptoms in adults with MDD. Participants will be randomly assigned to receive either Aticaprant or a placebo, in addition to their current antidepressant. The study will be conducted in a double-blind manner, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo. This helps ensure the results are unbiased. The study will last for a period of 43 days, during which participants will be closely monitored for any changes in their symptoms and overall health.

After the initial study period, there will be an open-label extension phase where all participants will have the opportunity to receive Aticaprant. This phase allows researchers to gather more information about the long-term effects and safety of the medication. Throughout the study, participants will undergo regular assessments to track their progress and any side effects they may experience. The ultimate goal is to determine if Aticaprant can be a beneficial addition to current treatment options for those struggling with MDD and anhedonia.

The research process

The trial runs in 4 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, you will be randomly assigned to receive either the study medication, aticaprant, or a placebo. A placebo is a tablet that looks like the medication but does not contain the active ingredient.

    The study is double-blind, meaning neither you nor the study team will know which treatment you are receiving. This helps ensure the results are unbiased.

  2. Step 2

    Medication administration

    You will take one tablet of aticaprant or placebo orally each day. The dosage of aticaprant is 10 mg.

    This medication will be taken in addition to your current antidepressant therapy, which includes either an SSRI or SNRI. SSRIs and SNRIs are types of antidepressants that help increase the levels of certain chemicals in the brain to improve mood.

  3. Step 3

    Duration of treatment

    The initial phase of the study will last for 43 days. During this time, your progress will be closely monitored to assess any changes in your symptoms.

    After the initial phase, there may be an opportunity to continue in a long-term extension of the study, where you will receive aticaprant openly, meaning you will know you are receiving the active medication.

  4. Step 4

    Monitoring and assessments

    Throughout the study, you will undergo regular assessments to monitor your health and the effectiveness of the treatment. This includes clinical assessments, vital signs checks, and laboratory tests.

    Your symptoms will be evaluated using the Montgomery-Åsberg Depression Rating Scale (MADRS), which measures the severity of depression. The primary goal is to observe any changes in your MADRS score from the start of the study to day 43.

Who can join the trial?

6 criteria

  • Adults aged 18 to 64 years can participate.
  • Must have a diagnosis of Major Depressive Disorder (MDD) based on a clinical assessment.
  • Must be experiencing a moderate to severe depressive episode, which means a certain level of depression severity as measured by a specific scale.
  • Must have symptoms of anhedonia, which is a reduced ability to feel pleasure, confirmed by a clinical assessment.
  • Must have had an inadequate response to at least one but no more than five antidepressant treatments, including current treatment with an SSRI or SNRI. These are types of medications used to treat depression.
  • Must be medically stable, meaning their overall health is stable based on medical assessments, vital signs, and lab tests.

Who cannot join the trial?

4 criteria

  • Having a medical condition other than Major Depressive Disorder (MDD) with moderate-to-severe Anhedonia (a condition where you find little or no pleasure in activities you usually enjoy).
  • Not having an inadequate response to current antidepressant therapy with an SSRI (Selective Serotonin Reuptake Inhibitor) or SNRI (Serotonin-Norepinephrine Reuptake Inhibitor).
  • Being outside the specified age range for the study.
  • Belonging to a vulnerable population that the study does not include.
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Investigated drugs

Aticaprant is a medication being studied to see if it can help improve symptoms of depression in people who have not had enough relief from their current antidepressant medications. It is used alongside other antidepressants to see if it can make them work better. The goal is to help people feel less depressed and more interested in activities they used to enjoy.

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 additional treatment for adults with Major Depressive Disorder (MDD) who experience moderate-to-severe anhedonia and have not responded adequately to their current antidepressant therapy. The medication works by targeting specific receptors in the brain to help improve mood and reduce symptoms of depression. Aticaprant is classified as an adjunctive therapy, meaning it is used alongside other antidepressants, specifically SSRIs or SNRIs, to enhance their effectiveness.

Investigated diseases

Major Depressive Disorder (MDD) with Moderate-to-severe Anhedonia – Major Depressive Disorder is a mental health condition characterized by persistent feelings of sadness, hopelessness, and a lack of interest or pleasure in activities. Anhedonia, a key feature in this context, refers to the reduced ability to experience pleasure. In moderate-to-severe cases, individuals may find it difficult to engage in daily activities and may experience significant emotional and physical symptoms. The disorder can lead to changes in sleep patterns, appetite, energy levels, and concentration. It often involves a cycle of depressive episodes that can vary in duration and intensity. The progression of symptoms can impact social, occupational, and other important areas of functioning.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-511557-21-00Protocol code67953964MDD3007Estimated enrolment362 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).