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Study on the Effects of BH-200 (Nelivaptan) 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 effects of a medication called Nelivaptan on individuals with Major Depressive Disorder (MDD). MDD is a mental health condition characterized by persistent feelings of sadness and loss of interest in activities. The study aims to evaluate how effective and tolerable a fixed dose of Nelivaptan, also known by its code name BH-200, is in improving symptoms of depression in patients who have a specific genetic profile related to the V1b receptor.

The trial will last for 14 weeks, with an 8-week period where participants will receive either Nelivaptan or a placebo. Participants will take the medication in capsule form, twice a day. Throughout the study, the participants' depressive symptoms will be monitored and assessed using various scales and questionnaires to determine any changes in their condition. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo, to ensure unbiased results.

The primary goal of this study is to see if Nelivaptan can effectively reduce depressive symptoms compared to a placebo. Participants will be regularly evaluated to track their progress and any side effects they may experience. This research could provide valuable insights into new treatment options for those suffering from Major Depressive Disorder.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria, including age, body mass index, and diagnosis of major depressive disorder.

    Participants must provide written informed consent and agree to stop any current antidepressant or prohibited psychotropic medication before the study begins.

  2. Step 2

    Baseline assessment

    A baseline assessment is conducted to evaluate the initial condition using various scales, such as the Hamilton Depression Rating Scale (HAMD-17) and the Montgomery-Åsberg Depression Rating Scale (MADRS).

    This assessment helps establish a starting point for measuring changes throughout the study.

  3. Step 3

    Treatment period

    The treatment period lasts for 8 weeks. During this time, participants receive either a fixed dose of BH-200 (250 mg twice daily) or a placebo.

    The medication is administered orally in capsule form.

  4. Step 4

    Regular assessments

    Throughout the treatment period, regular assessments are conducted to monitor changes in depressive symptoms and overall health.

    These assessments include various scales and questionnaires to evaluate mood, anxiety, and daily functioning.

  5. Step 5

    Follow-up visit

    A follow-up visit occurs after the 8-week treatment period to assess the participant's condition and any changes in symptoms.

    This visit includes a final evaluation using the same scales and questionnaires as during the treatment period.

  6. Step 6

    End of study

    The study concludes with a comprehensive review of all collected data to determine the efficacy and tolerability of the treatment.

    Participants are informed of the study's findings and any implications for their ongoing care.

Who can join the trial?

17 criteria

  • Must be a male or female patient.
  • The current episode of depression should not have lasted longer than 12 months before the screening.
  • Symptoms of depression must have been present for at least 2 weeks before the screening.
  • Must be willing to stop current antidepressant or other prohibited medications, except for certain sleeping and anti-anxiety medications, at least 7 days before the study starts.
  • If undergoing psychotherapy, it must have been ongoing for at least 6 weeks before screening and cannot be stopped or changed until 8 weeks after starting treatment.
  • If participating in a physical activity program, it must have been ongoing for at least 6 weeks before screening and cannot be stopped or changed until 8 weeks after starting treatment.
  • Ongoing hormone therapy for post-menopausal women, insulin for diabetes, and treatment for thyroid disorders are allowed if these conditions are well controlled.
  • Women who can have children must use highly effective birth control methods from the time of consent until 28 days after the last dose of the study drug.
  • Male patients must use effective birth control methods or practice abstinence during the study and for 28 days after the last dose of the study drug.
  • Must be between 18 and 75 years old at the time of consent. In Serbia, the age range is 18 to 65 years.
  • Body mass index (BMI) must be between 18 and 35 kg/m2.
  • Must be an outpatient, meaning not admitted to a hospital.
  • Must be able to understand the study's purpose and risks and provide signed consent.
  • In Bulgaria, a caregiver must be available for the study duration, and the caregiver must also provide consent.
  • Must have a primary diagnosis of **Major Depressive Disorder (MDD)**, which can be moderate or severe, with or without psychotic features, confirmed by specific diagnostic tools.
  • Can have certain other conditions like anxiety disorders or obsessive-compulsive disorder, as long as MDD is the main diagnosis and these conditions do not interfere with the study.
  • Must have a **MADRS score** of 20 or higher at screening and baseline. The MADRS score is a measure used to assess the severity of depression.

Who cannot join the trial?

10 criteria

  • Patients who have a history of severe allergic reactions to the study medication or similar medications.
  • Patients who are currently participating in another clinical trial.
  • Patients with a diagnosis of another major psychiatric disorder, such as schizophrenia or bipolar disorder.
  • Patients with a serious medical condition that could interfere with the study, such as uncontrolled diabetes or heart disease.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a substance abuse problem, meaning they use drugs or alcohol in a way that could affect their health or the study results.
  • Patients who have had a recent major surgery or are planning to have surgery during the study period.
  • Patients who are unable to follow the study procedures or take the study medication as directed.
  • Patients who have been hospitalized for depression in the past 6 months.
  • Patients who are at risk of harming themselves or others.
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Investigated drugs

BH-200 is a medication being studied for its potential to improve symptoms in patients with Major Depressive Disorder (MDD). The trial aims to evaluate how effective and tolerable this medication is when taken by outpatients. The study focuses on patients with a specific genetic profile, referred to as V1b-high, to see if this medication can help reduce their depressive symptoms.

What is already known about the treatment

BH-200 – BH-200 is administered orally in the form of tablets, taken twice daily at a fixed dose of 250 mg. It is currently in phase II clinical trials, being studied for its effectiveness and safety in treating Major Depressive Disorder (MDD). The medication is designed to alleviate depressive symptoms by targeting specific pathways in the brain, although the exact molecular mechanism is still under investigation. BH-200 is classified as an antidepressant, and its development is focused on patients with a high polygenic score for depression, aiming to provide a targeted therapeutic option.

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 feels, thinks, 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 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 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-513104-34-00Protocol codeBH-200-03Estimated enrolment324 patientsSponsorHMNC Holding GmbH

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).