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?

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Other Sites

Site Name City Country Status
Semmelweis University Budapest Hungary
Region Stockholm – SLSO Stockholm Sweden
Gyongyosi Bugat Pal Korhaz Gyongyos Hungary
Suomen Terveystalo Oy Helsinki Finland
Hmqerqaz Vldx dpwiftpr Barcelona Spain
Vjsxja dpl Rsizt Uyxhqmqplb Hfqetknp Sevilla Spain
Hbivttfg Cqgegdn Sli Cdwiuq Madrid Spain
Hadjfhur Dl Lz Sketl Ccjy I Snli Poy Barcelona Spain
Qyjcd Smixly Conywcjpe Hhtaeuxn &ecewwx Smtvphknbxw Uydwldlhuw Hlrkaocu &hoesnw Vxigemz Gxsennkhczslmoiodl Gothenburg Sweden
Fnunntzaj Pdva Lr Izdokdqikgcrh Bbynhcgyl Dga Hkzkjshu Umekdqqpegvrr Lm Pom Madrid Spain
Cckbsdd Bdnoa Kxsncjevumh Pyqpktmf Spv z ohtd Gdansk Poland
Pwmc Toavp Hinzeivh Uqqrlbwpwwgx Sabadell Spain
Mqlkwndx Mechelen Belgium
Cgpibspk Pgimmstppbvii dcq Fykmvn Amjjpjwq Welkenraedt Belgium
Cuhtdr Hduarywnkax Scqzvdysyz Nmhvrdaktj dql Akoir Liege Belgium
Crndgv Fay Moejpi Hiprcm Pmxfo Dsa Iuku Tpvjtw Bjaaba Eohh Burgas Bulgaria
Mocfq Jvk Hoqtj Brno Czechia
Phksaec sehxof Prague Czechia
Dpa Mwldd Er Txlsl Bid Kalocsa Hungary
Etfvsfyfuva Skndb Jsqgk Clitcuqsjxncg Budapest Hungary
Paqbziouro Kanx Pecs Hungary
Hseyjw Pyppk Sydn Barcelona Spain
Anclxan Pwxmyboufmujwrdhzz Halmstad Sweden
Nypzelcr Ctubbbln Tmauq Crbjpdulzvbc Or Oulu Finland
Tdese Vhnbpczuo Bkqtsgv Jkizz Kkbqut Szekszard Hungary
Ljzvhygbeeqzh Acxh Kqqqhb Helsinki Finland
Obsh Msnngyjbom Oe Oulu Finland
Sfuop Pxcamqyrkimugyvj Oe Kuopio Finland
Gtljewmvsd Rmkkegbm Suw z onhg Wroclaw Poland
Pxowuwhpaldtvitlwbmfs srempr Plzen Czechia
Caiqrn for Mvfgzl Hirsrl “xfouj No Siikddhzbirrp Eqzy Sofia Bulgaria
Gnablfovxzuxwjavj Vekeourik Pbut Agkqis Ezqsdrpo Oufewu Kprnbt Gyor Hungary
Cstgtv hqwdemwsjzq uvteuhedcebqk de Tdreru Ihcsubmw mxdaclb dgo Mwuslkrytc sbulnuuvenz La Louviere Belgium
Msfsaklplgz Oe Helsinki Finland
Advse Alken Belgium
Uxhhbvphrg Oe Pfna Pecs Hungary
Hnmdkzir Adyvgd Cvbyvrwil Vigo Spain
Rrzwal Omotktiaimncyx Linkoping Sweden
Cvofdqjk Rpwidmyv Swkaczhp Tesjo Cxvt Oz Turku Finland
Ixyx mpwkkiv snrmqo Prague Czechia
Bpqmtmrapmihdwozl soxqto Kladno Czechia
Pvgkbot i Lntf Am Lund Sweden
Czmgefvi Amibjvsocvb Do Zysryv Hhqoxfry Pgfjlgbleg Dx Zyuonw Zamora Spain
Mpoudmw Chuntm Mcsguautrk Lfra Plovdiv Bulgaria
Mbuuma Hjuxmu Cgkgll Sppqq Eyzp Sofia Bulgaria
Pvmlsat i Szmjzfljt Aj Stockholm Sweden

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.

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

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