Study on Long-term Safety and Effectiveness of NMRA-335140 for Patients with Major Depressive Disorder

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What is this study about?

This clinical trial is focused on studying the long-term safety and effectiveness of a medication called NMRA-335140 for individuals with Major Depressive Disorder (MDD). Major Depressive Disorder is a mental health condition characterized by persistent feelings of sadness and loss of interest in activities. The medication being tested is taken as a film-coated tablet once daily.

The purpose of the study is to evaluate how well NMRA-335140 is tolerated by participants over a period of 52 weeks. Participants who have completed a previous study involving this medication are eligible to continue in this trial. The study will monitor various health parameters, including any side effects, through regular assessments such as physical exams and questionnaires.

Throughout the study, changes in symptoms of depression and anxiety will be measured using different scales, such as the Montgomery-Åsberg Depression Rating Scale and the Hamilton Anxiety Rating Scale. The study aims to provide valuable information on the long-term use of NMRA-335140 in treating Major Depressive Disorder, helping to understand its impact on participants’ overall well-being and daily functioning.

1 joining the study

Participation begins after completing a previous NMRA-335140 Phase 3 study. An informed consent form must be signed to confirm understanding and agreement to participate.

In certain locations, a caregiver may be required to assist with monitoring and accompany the participant to study visits.

2 medication administration

The medication used in this study is called NMRA-335140, administered as a film-coated tablet.

The dosage is 80 mg taken once daily by mouth.

3 study duration

The study is designed to last for 52 weeks.

The primary focus is to assess the long-term safety and tolerability of the medication.

4 safety and effectiveness assessments

Regular assessments will be conducted to monitor safety and tolerability. These include checking for any adverse events, conducting laboratory tests, and performing physical examinations.

Additional evaluations include electrocardiograms (ECGs), eye examinations, and specific questionnaires to assess mental health and sexual functioning.

5 effectiveness evaluations

The effectiveness of the medication will be evaluated using various scales and questionnaires. These include the Montgomery-Åsberg Depression Rating Scale (MADRS), the Snaith-Hamilton Pleasure Scale (SHAPS), and the Patient Health Questionnaire-9 (PHQ-9).

Changes in anxiety and overall clinical impressions will also be measured using the Hamilton Anxiety Rating Scale (HAM-A) and the Clinical Global Impression scales.

Who Can Join the Study?

Must have completed a previous study with the medication NMRA-335140 for Major Depressive Disorder (MDD). This means finishing one of the specific studies mentioned in the study details.
Must have signed an informed consent form, which is a document that explains the study and confirms your agreement to participate.
If you are in the Czech Republic, you need a caregiver to help you during the study. This person should be in contact with you regularly and accompany you to study visits. The caregiver also needs to sign a consent form.
Must agree to follow the rules about using birth control as described in the previous study’s guidelines.
Must agree to follow the rules about using other medications or therapies as described in the previous study’s guidelines.
Both men and women can participate in the study.

Who Cannot Join the Study?

Patients with any other serious mental health conditions besides Major Depressive Disorder cannot participate. This means if you have another mental illness, you may not be eligible.
If you have a history of drug or alcohol abuse, you may not be able to join the study. This refers to using substances in a way that is harmful or addictive.
People with certain medical conditions that could interfere with the study medication or its effects are excluded. This means if you have a health issue that might affect how the study drug works, you might not be eligible.
Pregnant or breastfeeding women cannot participate. This is to ensure the safety of both the mother and the baby.
If you are currently participating in another clinical trial, you cannot join this one. This is to avoid any interference between different study treatments.
Individuals who have had a recent major surgery or are planning to have one during the study period are excluded. This is because surgery can affect your health and the study results.
Patients who are unable to follow the study procedures or take the study medication as directed are not eligible. This means if you cannot follow the instructions given by the study team, you may not be able to participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

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

Other Sites

Site Name	City	Country
Clinical Research Services Turku CRST Oy	Turku	Finland
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
ProbarE i Stockholm AB	Stockholm	Sweden
Dr. Ivo Natsov Outpatient Clinic For Individual Practice For Specialized Medical Care In Psychiatry ET	Cherven Bryag	Bulgaria
Centrum Medyczne Luxmed Sp. z o.o.	Lublin	Poland
Promente Sp. z o.o.	Bydgoszcz	Poland
A-Shine s.r.o.	Plzen	Czechia
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Multiprofile Hospital For Active Treatment – Targovishte AD	Targovishte	Bulgaria
Nervenärztliche Praxis Frau Dr. Kirsten HahN	Berlin	Germany
Diagnostic And Consultation Centre St.Vrach And St.St. Kuzma And Damian OOD	Sofia	Bulgaria
Medical Center Intermedica Ltd.	Sofia	Bulgaria
Cgduqb Hgozvscnroq Hphbb Lgnqjsb	Poitiers	France
Doycsnwsa Ruasqwhzr	Douai	France
Bslwsuthiktjzkjhc squomn	Kladno	Czechia
Oedj Mavrshymwk Od	Oulu	Finland
Pnvlffhc Gfuvitfo Lrfjarrqb „rzcuwzccgut Axtn Aujilbsyq Thzgodx	Bialystok	Poland
Elvkqa Guzv	Berlin	Germany
Gkihecwwax Ryobtomb Swy z orse	Wroclaw	Poland
Cxdzcf Hstdldrszld Rdqiaeba Dzosjvfknmento	Angers	France
Cgcufv Hredlvpijvz Gzxhesd Mgmqimhiff Ekir Mcnrfxauf	La Roche sur Yon	France
Lutekmtl Clcwdfspms Ox	Helsinki	Finland
Modkext Cbdxfe Azqhhbvtd Etbn	Sofia	Bulgaria

Trial status

Country	Status	Recruitment Start
Bulgaria	Not recruiting	26.08.2024
Czechia	Not recruiting	26.08.2024
Finland	Not recruiting	26.08.2024
France	Not recruiting	26.08.2024
Germany	Not recruiting	26.08.2024
Poland	Not recruiting	26.08.2024
Sweden	Not recruiting	26.08.2024

Trial locations

Investigated drugs:

1-[6-Ethyl-8-Fluoro-4-Methyl-3-(3-Methyl-1,2,4-Oxadiazol-5-Yl)Quinolin-2-Yl]-N-(Oxan-4-Yl)Piperidin-4-Amine

NMRA-335140 is a medication being studied for its safety and effectiveness in treating major depressive disorder. This trial is focused on understanding how well patients tolerate this medication over a long period, specifically over 52 weeks. The study aims to ensure that the medication is safe for long-term use in individuals with major depressive disorder.

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 sleep patterns, appetite, energy level, concentration, daily behavior, or self-esteem. Symptoms must last for at least two weeks for a diagnosis to be made. The severity and duration of symptoms can vary, and they may occur in episodes throughout a person’s life.

Trial ID:

2023-505892-56-00

Protocol code:

NMRA-335140-501

NCT ID:

NCT06029439

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Long-term Safety and Effectiveness of NMRA-335140 for Patients with Major Depressive Disorder

What is this study about?

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