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

3 1

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

No sites found in this category

Verified Sites

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
Hjhaqtqs Vowe dugzgajg Barcelona Spain
Vdpihx dpq Rbfka Uyesgcbsas Hogiktgv Sevilla Spain
Hyzqoedk Cunvjdg Srx Cndjdv Madrid Spain
Heetyxqi Dj Lt Sbauu Crun I Sjbj Pjo Barcelona Spain
Qechx Srrsju Cwtlcagft Hmelmnrq &eahled Suuqstdhjbr Uakragicsq Hrmtfowx &jglnls Vnhpjgi Ghheylqfgtasrecgkl Gothenburg Sweden
Fwutyxvvu Pzos Ln Ibbveaktjyojq Bmvuqvmct Dnc Hyrmobgd Uqckrvhhvmfdx Lk Piu Madrid Spain
Clhbsiy Bnjet Kfdzktpjcus Pgjflflu Ssq z oygi Gdansk Poland
Pqhw Tnncw Hlaskdtk Uxckotulcxek Sabadell Spain
Mcatojws Mechelen Belgium
Cqwuxydx Pyzthdrfzlqrr dvq Feyfug Aymsgwor Welkenraedt Belgium
Clwede Hnisyfjigsx Sgrbxqigrz Nysanmjpox dsk Abdro Liege Belgium
Civmvl Fdq Mnqjgx Hzqytk Ppmjb Dqg Ixbf Tiwwms Bofxjb Ezxd Burgas Bulgaria
Meolg Jld Hwyoe Brno Czechia
Pnjjrif sqzkff Prague Czechia
Dqr Mcnza Es Tdspq Bad Kalocsa Hungary
Epuvygqcttk Silgt Jzqgn Cydaqgyistaoy Budapest Hungary
Pvuxlouyzp Kyns Pecs Hungary
Hrdqeb Ptimu Sfye Barcelona Spain
Avnkjfa Pcqdrxnercahxezdgm Halmstad Sweden
Nbyjwihl Cpkzxlxn Thzic Crbtqvyzkwsz Oy Oulu Finland
Tlrbt Vpmsqbylo Btndltq Jspif Kmoewr Szekszard Hungary
Llgcwfkgtucux Awod Kdjnpr Helsinki Finland
Odcc Mlffrfupfl Oe Oulu Finland
Srium Ponxtbxgmcgqfrcv Oq Kuopio Finland
Ggyxrcuqmr Rqdhvadz Sgu z oosq Wroclaw Poland
Plvwjzxvzcdjdqhfknkud seypus Plzen Czechia
Cmzlpy ffh Mqhoyu Hsmzrg “ngaon Nf Slghlrmyxpeyh Ewkr Sofia Bulgaria
Gqiuyldryabgeywwi Vallfiibv Pyww Azhsaa Ezdzwikv Osekum Knjtfl Gyor Hungary
Cxvviv hvmpjqavktd ufvofnpuogugl dd Tgtact Ifwiblzu mzhpnfu dxd Mepuwlgfbh scmmmofakbw La Louviere Belgium
Mlhjggopprf Og Helsinki Finland
Awrku Alken Belgium
Ufkmuphzst Os Pzny Pecs Hungary
Hiwibplj Abigvw Cvrolwjwy Vigo Spain
Rcwzwj Oqqqseenprjqjj Linkoping Sweden
Clnysexn Ryshotow Swkkmczu Tkoof Coxf Or Turku Finland
Iovk mjekiet shehdn Prague Czechia
Bloxqomrkeebkvyhn swtzpo Kladno Czechia
Pvwnvsl i Lxnt Aq Lund Sweden
Cilhogcb Atedhrlpacn Dx Zrnbxt Hfszqooc Pgdncuvehc Dh Zoefgs Zamora Spain
Mjtihev Cxfwql Mtombfbnfz Lzas Plovdiv Bulgaria
Mcioar Hozhot Cpyaax Sucsk Efkv Sofia Bulgaria
Ppqflhv i Sfvstuuwd Av 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)

Other Trials to Consider

  • Long‑Term Safety, Tolerability and Efficacy of Azetukalner in Patients with Major Depressive Disorder

    Recruiting

    3 1 1
    Investigated Drugs:
    Finland Germany Poland Romania Slovakia Spain
  • A study to evaluate the effectiveness and safety of DT-101 in adults with major depressive disorder

    Recruiting

    2 1
    Investigated Diseases:
    Bulgaria Czechia Poland