Study on the Safety and Effectiveness of Aticaprant with Antidepressants for Adults and Elderly with Major Depressive Disorder

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What is this study about?

This clinical trial is focused on studying the effects of a medication called aticaprant on individuals with Major Depressive Disorder (MDD). The study aims to evaluate if adding aticaprant to a current antidepressant treatment is safe and can help improve symptoms of depression. Participants in the study will continue taking their existing antidepressant, which could be a type known as an SSRI or SNRI, while also taking aticaprant.

The purpose of the study is to assess the long-term safety and tolerability of aticaprant when used alongside a current antidepressant. The study will involve taking aticaprant in the form of a tablet by mouth. Participants will be monitored over a period of up to one year to observe any changes in their condition and to ensure the treatment is safe. The study will also look at various health indicators, such as vital signs, weight, and any side effects that may occur.

Throughout the study, participants will undergo regular health checks, including physical examinations and heart tests known as ECGs, to ensure they remain in good health. The study will also assess any changes in mood or behavior, including any thoughts of self-harm, using a specific rating scale. This trial is designed to provide valuable information on whether aticaprant can be a beneficial addition to existing depression treatments.

1 joining the study

Participants must have completed a previous study phase or meet specific medical criteria, including being medically stable and having a history of major depressive disorder (MDD).

Participants should be aged between 18 and 74 years and have an inadequate response to at least one oral antidepressant treatment in the current episode of depression.

2 baseline assessments

Participants undergo a physical examination, medical history review, vital signs check, and a 12-lead ECG to ensure medical stability.

Clinical laboratory tests are performed to confirm eligibility.

3 medication administration

Participants receive aticaprant in the form of a tablet for oral use.

Aticaprant is administered as an adjunctive therapy to a current antidepressant, which is either a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI).

4 ongoing assessments

Regular monitoring of adverse events (AEs), including those of special interest, is conducted.

Changes in vital signs, weight, and body mass index (BMI) are tracked.

Suicidality is assessed using the Columbia Suicidality Severity Rating Scale (C-SSRS).

Laboratory parameters and 12-lead ECGs are regularly evaluated.

5 withdrawal and sexual dysfunction assessments

Withdrawal symptoms are assessed using the Physician Withdrawal Checklist, 20-item (PWC-20).

The proportion of participants with clinically relevant sexual dysfunction is monitored over time using the Arizona Sexual Experiences Scale (ASEX) score.

6 study duration

The study is designed to last up to one year, with an estimated end date of December 1, 2025.

Who Can Join the Study?

  • Participants must have completed the Double Blind Treatment Phase of Study 67953964MDD3001 or Study 67953964MDD3002.
  • Participants must be medically stable based on a physical exam, medical history, vital signs (like blood pressure), and a heart test called a 12-lead ECG, done at the start and before beginning the Open Label treatment.
  • Participants can be male or female, aged 18 to 74 years old.
  • Participants must be medically stable based on a physical exam, medical history, vital signs, and a 12-lead ECG done at screening and baseline.
  • Participants must be medically stable based on clinical lab tests done at screening.
  • Participants must meet the DSM-5 diagnostic criteria for Major Depressive Disorder (MDD), which means having repeated or single episodes of depression without psychotic features. If participants are 65 years or older, their first depression episode must have occurred before they were 55 years old.
  • Participants must have had an inadequate response to at least one oral antidepressant treatment, given at a proper dose and for a sufficient time during the current depression episode.
  • Participants must be taking and tolerating well a type of antidepressant called SSRI or SNRI for depressive symptoms at screening, and the dose must have been stable for at least 6 weeks.
  • Participants must have a HDRS-17 total score of 20 or higher at the first and second screening interviews and must not show a significant improvement between these two assessments. HDRS-17 is a scale used to measure the severity of depression symptoms.

Who Cannot Join the Study?

  • Patients who are not diagnosed with Major Depressive Disorder cannot participate. This is a condition where a person feels very sad, hopeless, and loses interest in activities for a long time.
  • Patients who are not taking a current antidepressant medication, specifically an SSRI or SNRI, cannot participate. SSRIs and SNRIs are types of medications that help improve mood by affecting certain chemicals in the brain.
  • Patients who are not within the specified age range cannot participate. The study is open to certain age groups only.
  • Patients who are not part of the specified clinical trial group cannot participate. This means the study is looking for specific types of participants.
  • Both male and female patients are eligible, so gender is not a reason for exclusion.
  • Patients who are considered part of a vulnerable population may not be eligible. This refers to groups of people who might need special protection or care.

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
Medical Center Hera EOOD Sofia Bulgaria
ASST Fatebenefratelli Sacco Milan Italy
Vitaz Sint-Niklaas Belgium
CCAB Centro Clinico Academico Braga Associacao Braga Portugal
Region Stockholm – SLSO Stockholm Sweden
INEP medical s.r.o. Prague Czechia
Diagnostics-Consultancy Center Mladost M Varna OOD Varna Bulgaria
ProbarE i Lund AB Lund Sweden
ProbarE i Stockholm AB Stockholm Sweden
Dr. Ivo Natsov Outpatient Clinic For Individual Practice For Specialized Medical Care In Psychiatry ET Cherven Bryag Bulgaria
Center Za Psihichno Zdrave Veliko Tarnovo EOOD Veliko Tirnovo Bulgaria
Medical Center Saint Naum EOOD Sofia Bulgaria
Medical Center Mentalcare Ltd. Plovdiv Bulgaria
Narodni Ustav Dusevniho Zdravi Klecany Czechia
Hospital El Bierzo Ponferrada Spain
Crystal Comfort s.r.o. Vranov Nad Toplou Slovakia
Liptovska Nemocnica S Poliklinikou Mudr. Ivana Stodolu Liptovsky Mikulas Liptovsky Mikulas Slovakia
Obudai Egeszseguegyi Centrum Kft. Dunaújváros Hungary
Tolna Vármegyei Balassa János Kórház Szekszard Hungary
Clintrial s.r.o. Prague Czechia
A-Shine s.r.o. Plzen Czechia
Univerzitna nemocnica L. Pasteura Kosice Kosice Slovakia
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Hospital Clinic De Barcelona Barcelona Spain
Semmelweis University Budapest Hungary
Champalimaud Clinical Centre Lisbon Portugal
San Raffaele Scientific Institute Milan Italy
Centre Hospitalier Universitaire De Nantes Nantes France
Hospital Cuf Tejo S.A. Lisbon Portugal
Anima Alken Belgium
Gyongyosi Bugat Pal Korhaz Gyongyos Hungary
Hospital Alvaro Cunqueiro Vigo Spain
University Childrens Hospital Queen Fabiola Brussels Belgium
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen Gothenburg Sweden
MUDr. Simona Papezova s.r.o. Prague Czechia
Cromed Sp. z o. o Poznan Poland
Diagnostic And Consultation Centre St.Vrach And St.St. Kuzma And Damian OOD Sofia Bulgaria
Forbeli s.r.o. Prague Czechia
Epamed s.r.o. Kosice Slovakia
Medical Center Intermedica Ltd. Sofia Bulgaria
Care Clinic Sp. z o.o. Katowice Poland
Ayiq szkchn Prague Czechia
Dgddehgwu Rfnxesnac Douai France
Cnqyozy Bnize Kxlwmvlhkpg Pbuvqukh Sxk z oeai Gdansk Poland
Eqiepxa Duffel Belgium
Cilezm Fhl Mdplof Hjapsd Rmuj Evvd Ruse Bulgaria
Nprvbeqcagik Kq spyffc Prague Czechia
Nukadxoaorjenrcc Pyncelj sorjtk Prague Czechia
Pclthdyfcr Ktav Pecs Hungary
Anbvyhz Stlgfkswg Ljxbzt Dklol Pcpfvbxtx Da Lanct Lecce Italy
Hsiaye Poosy Szyz Barcelona Spain
Mhiwuronjz Snrlgvxefmfsdez Pqbxjnfmstkbvx Goqkvkh Llpccgyy Jgyrzk Łebkcdcwg Bialystok Poland
Pvnkuvfiom sbfmrt Rimavska Sobota Slovakia
Dfpr Irwoscyekgqwdg siuvg swippcd Banska Bystrica Slovakia
Mrgpaf sufvof Stare Mesto Slovakia
Mmdnmb Hwrrpd Cmgfqz Simel Edyv Sofia Bulgaria
Grnnwq Hxtteempnnf Upczfurfocoqy Pxaev Pmtgdtwacgc Ek Nadkgjdeanto Paris France
Pnej Tdavz Hogyqtkm Uwymphsbpdvs Sabadell Spain
Bquptxwyshe Vawtwtbyo Oohkupwgilsn Kecskemet Hungary
Ojzkijc Brhzf Kpepyyvrtoa Cunaezugd Snky Eue Gckdlwskrvied Mkxbkxymut Tjiepyx Bydgoszcz Poland
Gmzawpt Lcmbxoor Pzuhmjpstzaxzj Ipptmmvh Kgpgvosndpd Belchatów Poland
Ailyigq Ongaslivojx Uljnpspdwlqbl Suuigv Siena Italy
Clroos Hvumpttohff Rtbgkcvs Unthtnbbvbzcc Dl Tjchp Tours France
Aqnxwja Ordeyhgopkp Pbda Geojbgdb Xnkid Bergamo Italy
Ubiijzotxh Magiz Ghgwdjt Oq Cuvncelhf Catanzaro Italy
Fdfohugrn Pwfl Ly Itvkykomzrylx Bjuxkqmdi Dhn Hkocaayp Udmyhxumbkfhf Lv Pxn Madrid Spain
Ipegwqfncabf Sklahyzfxpbzzpl Ptaepphl Lwexoaem Poznan Poland
Nnjrxpift s pbonihhyrhna Pdlcghsym sd stubxh v Bdqfyjcvye Bojnice Slovakia
Hhufwcqi Vdrh dgerdmvl 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
04.08.2023
Bulgaria Bulgaria
Not recruiting
04.08.2023
Czechia Czechia
Not recruiting
04.08.2023
France France
Not recruiting
04.08.2023
Hungary Hungary
Not recruiting
04.08.2023
Italy Italy
Not recruiting
04.08.2023
Poland Poland
Not recruiting
04.08.2023
Portugal Portugal
Not recruiting
04.08.2023
Slovakia Slovakia
Not recruiting
04.08.2023
Spain Spain
Not recruiting
04.08.2023
Sweden Sweden
Not recruiting
04.08.2023

Trial locations

Investigated drugs:

Aticaprant is being studied as an additional treatment for adults and elderly people with Major Depressive Disorder (MDD). It is used alongside a current antidepressant to see if it can help improve symptoms of depression over a long period. The study aims to understand how safe and tolerable this medication is when used with other antidepressants.

SSRI (Selective Serotonin Reuptake Inhibitor) is a type of antidepressant that is commonly used to treat depression. It works by increasing the level of serotonin, a chemical in the brain that helps improve mood.

SNRI (Serotonin-Norepinephrine Reuptake Inhibitor) is another type of antidepressant used to treat depression. It works by increasing the levels of serotonin and norepinephrine, chemicals in the brain that help regulate mood and may help relieve symptoms of depression.

Major Depressive Disorder – This is a mental health condition characterized by persistent feelings of sadness, hopelessness, and a lack of interest or pleasure in activities. It can affect how a person thinks, feels, and handles daily activities, such as sleeping, eating, or working. The disorder often involves changes in appetite and sleep patterns, decreased energy, and difficulty concentrating. Individuals may experience feelings of worthlessness or excessive guilt. The symptoms can vary in intensity and may occur in episodes that last for weeks or longer.

Trial ID:
2023-508163-74-00
Protocol code:
67953964MDD3003
Trial Phase:
Therapeutic confirmatory (Phase III)

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