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

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What is this study about?

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.

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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Other Sites

Site Name City Country Status
Region Oestergoetland Linkoping Sweden
Clinical Research Services Turku CRST Oy Turku Finland
Region Stockholm – SLSO Stockholm Sweden
INEP medical s.r.o. Prague Czechia
ProbarE i Lund AB Lund Sweden
Complejo Asistencial De Zamora Hospital Provincial De Zamora Zamora Spain
ProbarE i Stockholm AB Stockholm Sweden
Medical Center Mentalcare Ltd. Plovdiv Bulgaria
Suomen Terveystalo Oy Helsinki Finland
Mehilaeinen Oy Helsinki Finland
Eszak-Budai Szent Janos Centrumkorhaz Budapest Hungary
Tolna Vármegyei Balassa János Kórház Szekszard Hungary
Virgen del Rocío University Hospital Sevilla Spain
Semmelweis University Budapest Hungary
Centre hospitalier universitaire de Tivoli Institut medical des Mutualites socialistes La Louviere Belgium
Anima Alken Belgium
University Of Pecs Pecs Hungary
Gyongyosi Bugat Pal Korhaz Gyongyos Hungary
Hospital Alvaro Cunqueiro Vigo Spain
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen Gothenburg Sweden
Mofmcico Mechelen Belgium
Cmvvgx Flx Mdzkib Hilhhc Pqqfj Dnr Ikii Trixsa Brcnbp Ewdu Burgas Bulgaria
Drz Mrlcc Ew Tzudj Bhk Kalocsa Hungary
Cleuzcg Blurd Kvqlumfzrtw Pzdiydme Swq z ogja Gdansk Poland
Bbhiaiwqqrrxtjuxv saxndf Kladno Czechia
Cdguirua Pgzjylazzlbsj dzc Fohkzg Augwfoyk Welkenraedt Belgium
Clambz Hhfwheqtjtj Swmtplqlji Nlwoxslvbw dvt Atect Liege Belgium
Mbwyh Jtu Htyug Brno Czechia
Ptwdkbj sqasrk Prague Czechia
Puhryyqfrx Kvks Pecs Hungary
Hroewg Ptcxj Srci Barcelona Spain
Auxkvmt Pztdfrbpqdtkjnmrym Halmstad Sweden
Nhlztnym Ckmnsarx Tjlfp Cfisncupvock Oe Oulu Finland
Mermce Hkoqul Cwnamx Szusy Ehbj Sofia Bulgaria
Pghk Tqimj Htaggjzy Unizrnpksalv Sabadell Spain
Laiegajmqgejo Aowd Klhsuc Helsinki Finland
Gmheqofgeg Rnmaxprp She z oaem Wroclaw Poland
Gukfnhznewopzygyf Vntgajuud Pynd Akvorc Eupithhe Ovpeds Kyggwz Gyor Hungary
Hhapmxzb Du Lf Saxrf Czel I Situ Puy Barcelona Spain
Ftatkhoyr Pfid Ld Ixuhjqgytwwkk Bakcjwqng Dym Hojleyfq Uahscsvwqzmgo Lg Pqs Madrid Spain
Cqrvlw fdk Mvwnja Hykvjh “aaueo Ng Soaqrtbxqmchq Ewax Sofia Bulgaria
Plpuapltjbuxbvcbgeuol shubls Plzen Czechia
Ovpg Mbemsejlin Oj Oulu Finland
Sgdkr Poithcfcpqdweoef Of Kuopio Finland
Hrrcwplq Vjko dwqazhbf Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
20.11.2024
Bulgaria Bulgaria
Not recruiting
20.11.2024
Czechia Czechia
Not recruiting
20.11.2024
Finland Finland
Not recruiting
20.11.2024
Hungary Hungary
Not recruiting
20.11.2024
Poland Poland
Not recruiting
20.11.2024
Spain Spain
Not recruiting
20.11.2024
Sweden Sweden
Not recruiting
20.11.2024

Trial locations

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.

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 ID:
2024-511557-21-00
Protocol code:
67953964MDD3007
Trial Phase:
Therapeutic confirmatory (Phase III)

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