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

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

6 criteria

  • 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 trial?

7 criteria

  • 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.
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Investigated drugs

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.

What is already known about the treatment

NMRA-335140 – This medication is administered orally in the form of a tablet, taken once daily. It is currently under investigation in clinical trials for its long-term safety and effectiveness in treating Major Depressive Disorder (MDD). The main therapeutic indication for NMRA-335140 is to alleviate symptoms associated with MDD. At the molecular level, it is believed to work by modulating neurotransmitter activity in the brain, which can help improve mood and emotional balance. NMRA-335140 is classified pharmacologically as an antidepressant.

Investigated diseases

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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-505892-56-00Protocol codeNMRA-335140-501Estimated enrolment1 005 patientsSponsorNeumora Therapeutics Inc.

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