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Study on the Effects of NMRA-335140 for Adults with Major Depressive Disorder

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What is this study about?

This clinical trial is focused on studying the effects of a new treatment for Major Depressive Disorder (MDD), a condition characterized by persistent feelings of sadness and loss of interest. The treatment being tested is a medication called NMRA-335140, which is taken orally in the form of a film-coated tablet. This medication is a type of drug known as a kappa opioid receptor antagonist, which means it works by blocking certain receptors in the brain that are thought to be involved in depression.

The purpose of the study is to evaluate how effective NMRA-335140 is in reducing symptoms of depression compared to a placebo. Participants in the study will be randomly assigned to receive either NMRA-335140 or a placebo, which looks like the active medication but does not contain the active drug substance. The study will last for six weeks, during which participants will take the medication daily. Throughout the study, participants will be monitored to assess changes in their symptoms of depression.

This trial aims to provide valuable information about the potential benefits of NMRA-335140 for individuals with Major Depressive Disorder. By comparing the effects of the medication to a placebo, researchers hope to determine whether NMRA-335140 can offer a new treatment option for those affected by this condition.

1 joining the study

Upon joining the study, the participant is confirmed to have a primary diagnosis of major depressive disorder (MDD) without psychotic features. This is verified through a structured clinical interview.

The current episode of depression must have been present for more than 4 weeks but less than 12 months before the screening visit.

2 baseline assessment

The participant’s symptoms are assessed using the Montgomery-Åsberg Depression Rating Scale (MADRS). A total score of 25 or higher is required at both screening and baseline.

A change in the MADRS total score between screening and baseline must be 20% or less.

3 randomization and treatment

Participants are randomly assigned to receive either the active medication NMRA-335140 or a placebo. The study is double-blind, meaning neither the participant nor the researchers know which treatment is being administered.

The active medication, NMRA-335140, is a kappa opioid receptor antagonist. It is administered orally in the form of a film-coated tablet.

The dosage is 80 mg per day, and the treatment period lasts for 6 weeks.

4 treatment evaluation

The primary goal is to evaluate the change in the MADRS total score from baseline to week 6.

A secondary evaluation involves assessing changes in the Snaith-Hamilton Pleasure Scale (SHAPS) total score over the same period.

5 completion of the study

The study is estimated to conclude by June 2, 2025. Participants will have completed the 6-week treatment period by this time.

Who Can Join the Study?

  • The patient must have a primary diagnosis of Major Depressive Disorder (MDD) without psychotic features. This diagnosis should be confirmed by a structured interview used in clinical trials.
  • The patient’s current major depressive episode must be confirmed by an independent assessment.
  • The symptoms of the current MDD episode must have been present for more than 4 weeks but no longer than 12 months before the screening visit.
  • The patient must have a MADRS total score of 25 or higher at both the screening and baseline visits. MADRS stands for Montgomery-Åsberg Depression Rating Scale, which is a tool used to measure the severity of depression symptoms.
  • The change in the MADRS total score between the screening and baseline visits must be 20% or less.
  • Both male and female patients are eligible to participate.

Who Cannot Join the Study?

  • Patients who have a different condition than Major Depressive Disorder cannot participate. This means if you have another mental health condition, you may not be eligible.
  • Patients who are not within the specified age range for the study cannot participate. The study is looking for adults, so if you are too young or too old, you may not be eligible.
  • Patients who are not able to follow the study procedures or take the study medication as required cannot participate. This means if you have difficulty following instructions or taking medication regularly, you may not be eligible.
  • Patients who have a medical condition that could interfere with the study medication or its effects cannot participate. This means if you have a health issue that might affect how the study drug works, you may not be eligible.
  • Patients who are pregnant or breastfeeding cannot participate. This is to ensure the safety of both the mother and the baby.
  • Patients who are currently participating in another clinical trial cannot participate. This is to avoid any interference between different study treatments.
  • Patients who have a history of substance abuse or addiction that could interfere with the study cannot participate. This means if you have had problems with drugs or alcohol that might affect the study, you may not be eligible.
  • Patients who have had a recent major surgery or are planning to have surgery during the study cannot participate. This is to ensure that recovery from surgery does not affect the study results.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Indywidualna Specjalistyczna Praktyka Lekarska Agnieszka Remlinger-Molenda Suchy Las Poland
University Hospital Of Clermont-Ferrand Clermont Ferrand France

Other Sites

Site Name City Country Status
Nervenärztliche Praxis Frau Dr. Kirsten HahN Berlin Germany
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Centre Hospitalier Universitaire De Montpellier Montpellier France
Multiprofile Hospital For Active Treatment – Targovishte AD Targovishte Bulgaria
Centre Hospitalier Universitaire De Nimes Nimes France
Clinical Research Services Turku CRST Oy Turku Finland
FutureMeds GmbH Berlin Germany
Klinische Forschung Berlin-Mitte GmbH Berlin Germany
Klinische Forschung Hamburg GmbH Hamburg Germany
E4r&D Sp. z o.o. Gdansk Poland
INEP medical s.r.o. Prague Czechia
Diagnostics-Consultancy Center Mladost M Varna OOD Varna Bulgaria
Centrum Medyczne Luxmed Sp. z o.o. Lublin Poland
Promente Sp. z o.o. Bydgoszcz Poland
ProbarE i Stockholm AB Stockholm Sweden
Dr. Ivo Natsov Outpatient Clinic For Individual Practice For Specialized Medical Care In Psychiatry ET Cherven Bryag Bulgaria
A-Shine s.r.o. Plzen Czechia
Diagnostic And Consultation Centre St.Vrach And St.St. Kuzma And Damian OOD Sofia Bulgaria
Medical Center Intermedica Ltd. Sofia Bulgaria
Oeyu Mdwdxqcqcg On Oulu Finland
Crsxrs Hkkuxgtiaep Htuqi Lxdcagh Poitiers France
Dtjhmgunx Rwmxeezoi Douai France
Ladihksx Cmgyiyxgaj Oa Helsinki Finland
Cckufp Hvbmwjvsnoe Gqtjrlv Mbmbmmbnub Ephn Mjcfmsrgi La Roche sur Yon France
Mklxjlu Ckbxiw Arpvjprox Erpf Sofia Bulgaria
Brpbnhhtldjgygdpq sbitmx Kladno Czechia
Gddqjzfxux Raqexhfo Scs z oyxv Wroclaw Poland
Cfqmvn Hpwaekrmcpo Rgxeeusw Dgbtaglwydfwbf Angers France
Pxukfjlh Gfngjtqt Lvkuixrcz „qtsagwdtkhn Ayax Ayvpggvrn Tnkszzz Bialystok Poland

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

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Not recruiting
15.07.2024
Czechia Czechia
Not recruiting
15.07.2024
Finland Finland
Not recruiting
15.07.2024
France France
Not recruiting
15.07.2024
Germany Germany
Not recruiting
15.07.2024
Poland Poland
Not recruiting
15.07.2024
Sweden Sweden
Not recruiting
15.07.2024

Trial locations

Investigated drugs:

NMRA-335140 is a medication being studied for its potential effects on major depressive disorder. It works as a kappa opioid receptor antagonist, which means it blocks certain receptors in the brain that may be involved in mood regulation. The trial aims to determine if this medication can help reduce symptoms of depression in adults with major depressive disorder after six weeks of treatment.

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 a person’s thoughts, behavior, and overall well-being. Symptoms may include changes in appetite, sleep disturbances, fatigue, and difficulty concentrating. The disorder can vary in severity and duration, with some individuals experiencing recurrent episodes. It often interferes with daily functioning and can lead to emotional and physical problems. The progression of the disorder can differ from person to person, with some experiencing gradual improvement while others may have persistent symptoms.

Trial ID:
2023-506335-15-00
Protocol code:
NMRA-335140-303
NCT ID:
NCT06058039
Trial Phase:
Therapeutic confirmatory (Phase III)

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