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

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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. 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.

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 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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Praglandia s.r.o. Prague Czechia
Vivantes Netzwerk fuer Gesundheit GmbH Berlin Germany
Geniko Nosokomeio Thessalonikis George Papanikolaou Thessaloniki Greece
Mtz Clinical Research Powered By Pratia Warsaw Poland
Vitaz Sint-Niklaas Belgium
Klinische Forschung Berlin-Mitte GmbH Berlin Germany
University General Hospital Of Heraklion Heraklion Greece
Hospital Universitario Basurto Bilbao Spain
Klinische Forschung Hamburg GmbH Hamburg Germany
Hospital Universitario Virgen De Las Nieves Granada Spain
INEP medical s.r.o. Prague Czechia
Diagnostics-Consultancy Center Mladost M Varna OOD Varna Bulgaria
Centru De Evaluare Si Tratament A Toxicodependentelor Pentru Tineri Sf. Stelian Bucharest Romania
Medical Center Mentalcare Ltd. Plovdiv Bulgaria
Centre Hospitalier Du Rouvray Sotteville Les Rouen France
Centrum Medyczne Luxmed Sp. z o.o. Lublin Poland
Hospital El Bierzo Ponferrada Spain
Centre Hospitalier Intercommunal Toulon / La Seine-Sur-Mer Toulon France
Clintrial s.r.o. Prague Czechia
A-Shine s.r.o. Plzen Czechia
Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara Romania
University General Hospital Of Ioannina Ioannina Greece
Nervenärztliche Praxis Frau Dr. Kirsten HahN Berlin Germany
Niepubliczny Zaklad Opieki Zdrowotnej Euromedica Sp. z o.o. Grudziadz Poland
Sint-Lucas General Hospital Brugge Belgium
Centre Hospitalier Universitaire De Montpellier Montpellier France
Centre Hospitalier Universitaire De Nantes Nantes France
Centre hospitalier universitaire de Tivoli Institut medical des Mutualites socialistes La Louviere Belgium
Anima Alken Belgium
Eginitio Hospital Athens Greece
HELIOS Kliniken Schwerin GmbH Schwerin Germany
Vrije Universiteit Brussel Jette Belgium
Servei De Salut De Les Illes Balears Palma Spain
Diagnostic And Consultation Centre St.Vrach And St.St. Kuzma And Damian OOD Sofia Bulgaria
Forbeli s.r.o. Prague Czechia
Institutul De Psihiatrie Socola Lasi Iasi Romania
Hospital Universitario Virgen De La Victoria Malaga Spain
Ctrewedod Ugsyfjcrgbqbzk Soisjcpov Woluwe-Saint-Lambert Belgium
Miachgqw Mechelen Belgium
Cywpsx Hjdnmzafnpn Hfrrh Lckeleh Poitiers France
Clau Aushmd Pestul Slb z ofsv Warsaw Poland
Coeczn Hijdxuulsvq Stetbqrfki Ndklkafyua diz Auyiq Liege Belgium
Msfiiwg Czuies Ajsuwyasq Etcd Sofia Bulgaria
Cckedy Fag Mquxtq Hiryrk Rpxz Ejbc Ruse Bulgaria
Mysjth sayecq Brno Czechia
Pdwbied syoguq Prague Czechia
Nfgaxonszonz Ky sxwfld Prague Czechia
Bibtumftbkrq Pyuhpomg &nkfskn Psyziv fsa Pjorhyfsjaja Piberkwawjukhpu Noqfmrqvld Rosenheim Germany
Oxmbaigkk Kpiywvzl Gghf Hennigsdorf Germany
Stfyzyaq Dv Pwmutcddah &qwwdtrsdhmrofmm Duyoouirrndsu Gwsbwh Galati Romania
Sjcktgbggsz Wkbhtbnjem Zlpzug Pucndqtlagl Zfyclkuu Pzudvjkdzuwdztz Otxzel Zhtbtcyycj W Wnlxftmdr Warsaw Poland
Coniuzm Zunxsqd Mpcwa Wroclaw Poland
Clvomn Fzg Mtrsel Htrnmm Vcjogz Eprk Vratsa Bulgaria
Ojxbzri Bjwls Knqwolpyddb Csaenlxja Skrk Ejg Giczplluribfs Mhbkuwpnss Tkgjoks Bydgoszcz Poland
Nveitxmuhomd Zhhfqz Oikphn Pzajdgbxkizwsoe Mpmhge Leszno Poland
Icbxaeuvso Pszwub dx Ckhfihpqi Mojbqceviwq pfltle Bqdk Actbcohqsr Efmpjbpzg sl Rvhs Craiova Romania
Bnxjduxh Ulupvxronl Hnbobehh Cplgne Besançon France
Ucpsosfuebodarqhgljar Mlfmfbjy Aiv Munster Germany
Grqzqk Uggbvskldf Ftomyjpgc Frankfurt Germany
Ftrqsqoan Puot Lb Ikrhddiamifqa Bewsmskmg Din Hjxsnojg Uqxwiwqdmnnde Lw Pug Madrid Spain
Pupiezylxlstgbgnoxbpn skbbzy Plzen Czechia
Shccxlyzjzoxfh Dcs Bvjadeg Gvpj Böblingen Germany
Uipflsitjy Golucpl Hqgljkak Afnhcjk Athens Greece

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
30.11.2024
Bulgaria Bulgaria
Not recruiting
30.11.2024
Czechia Czechia
Not recruiting
30.11.2024
France France
Not recruiting
30.11.2024
Germany Germany
Not recruiting
30.11.2024
Greece Greece
Not recruiting
30.11.2024
Poland Poland
Not recruiting
30.11.2024
Romania Romania
Not recruiting
30.11.2024
Spain Spain
Not recruiting
30.11.2024

Trial locations

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.

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 ID:
2024-511057-22-00
Protocol code:
67953964MDD3005
Trial Phase:
Therapeutic confirmatory (Phase III)

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