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Study of evenamide as add-on treatment for patients with treatment-resistant schizophrenia not adequately controlled by current antipsychotic medications

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What is this trial about?

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

This study focuses on patients with treatment-resistant schizophrenia, a severe mental health condition where symptoms persist despite trying multiple medications. The study will test a new medication called evenamide in patients whose symptoms are not well controlled by their current antipsychotic medications. Treatment-resistant schizophrenia can include persistent symptoms such as disorganized thinking, hallucinations, and unusual thoughts that significantly impact daily life.

The purpose of this research is to determine if evenamide, when added to existing antipsychotic medication, can help improve schizophrenia symptoms. The study will compare two different doses of evenamide (15 mg and 30 mg taken twice daily) to a placebo. Participants will continue taking their current antipsychotic medication throughout the study.

The study will last for 52 weeks, with the main evaluation of the medication's effectiveness occurring after 12 weeks of treatment. During this time, participants will receive either evenamide capsules or placebo capsules to take twice daily along with their regular medication. The study will monitor both how well the medication works and any side effects that may occur.

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

    Initial assessment

    A baseline evaluation will be performed to assess your current condition using specific rating scales

    Your current symptoms and medical history will be reviewed to confirm treatment-resistant schizophrenia

    You must have been on stable antipsychotic medication for at least 6 weeks before starting the study

  2. Step 2

    Treatment assignment

    You will be randomly assigned to receive either evenamide (15 mg or 30 mg) or placebo twice daily

    The medication comes in capsule form and should be taken by mouth

    You will continue taking your current antipsychotic medication throughout the study

  3. Step 3

    12-week primary assessment period

    You will take the study medication twice daily for 12 weeks

    Regular assessments will track changes in your symptoms using the Positive and Negative Syndrome Scale (PANSS)

    Your overall condition will be monitored using the Clinical Global Impression Scale (CGI-S)

    Any side effects or health changes will be recorded during this period

  4. Step 4

    Extended treatment period

    The study continues for a total of 52 weeks

    You will continue taking the assigned medication twice daily

    Regular check-ups will continue to monitor your health and symptoms

    Side effects and any changes in your condition will be documented throughout this period

  5. Step 5

    Safety monitoring

    Throughout the study, your health will be closely monitored

    Any side effects will be recorded and evaluated

    If you are taking clozapine, regular blood tests will be required according to local guidelines

    Your medication adherence will be tracked throughout the study period

Who can join the trial?

15 criteria

  • Must be 18 years or older
  • Must have a total score of 70 or higher on the Positive and Negative Syndrome Scale (a test that measures schizophrenia symptoms)
  • Must have a score of 50 or lower on the Global Assessment of Functioning scale (a scale that measures how well you function in daily life)
  • Must be taking prescribed antipsychotic medications regularly as confirmed by caregiver
  • Must have relatively stable symptoms for at least 3 months before screening
  • Must be able to take oral medication and understand study procedures
  • Must live with a caregiver or have regular contact with a responsible person at least 3 times per week
  • Must provide written informed consent
  • Must have tried at least two different antipsychotic medications in the past without adequate improvement
  • Must be currently taking approved antipsychotic medication(s) at a stable dose for at least 6 weeks
  • Must have a Body Mass Index (BMI) between 17.5 and 35 (weight in relation to height)
  • If female and able to become pregnant, must use effective birth control during the study
  • If taking clozapine (a specific antipsychotic medication), must agree to regular blood monitoring
  • Must not be pregnant or breastfeeding if female
  • Must be rated as mildly to severely ill by the doctor using a specific rating scale

Who cannot join the trial?

15 criteria

  • Current diagnosis of substance use disorder (except nicotine or caffeine) within the past 6 months
  • History of seizures or any medical condition that could cause seizures
  • Significant heart problems or abnormal heart rhythm
  • Severe liver or kidney disease
  • Pregnant women or those planning pregnancy during the study period
  • Breastfeeding mothers
  • History of severe allergic reactions to medications
  • Participation in another clinical trial within the past 30 days
  • Unstable medical conditions that could interfere with the study
  • History of not following prescribed medical treatments
  • Significant changes in psychiatric medications within the past 4 weeks
  • Active thoughts of self-harm or suicide
  • Unable to provide informed consent
  • Any condition that, in the investigator's opinion, makes participation unsafe
  • History of severe psychiatric symptoms that required hospitalization in the past 3 months
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Investigated drugs

  • Evenamide

    is a new medication being studied as an add-on treatment for patients with treatment-resistant schizophrenia. It works alongside existing antipsychotic medications when the current treatment alone is not providing adequate control of schizophrenia symptoms. This medication is being tested to see if it can help improve the symptoms of schizophrenia when other treatments haven't worked well enough.

  • Antipsychotic medications

    (current patient medications) are medicines that patients in the trial will continue taking at their usual stable dose. These are the existing medications that patients were already using to manage their schizophrenia symptoms before joining the study.

What is already known about the treatment

Evenamide - An investigational drug administered orally twice daily (bid) that is being studied as an add-on treatment for treatment-resistant schizophrenia. The medication is currently undergoing Phase III clinical trials to evaluate its efficacy and safety when used in combination with existing antipsychotic medications at fixed doses of 15 mg and 30 mg twice daily. Evenamide represents a potential new therapeutic option for patients whose schizophrenia symptoms are not adequately controlled by their current antipsychotic treatment, with its effectiveness being measured through changes in the Positive and Negative Syndrome Scale (PANSS) scores over a 12-week period.

Investigated diseases

Treatment-resistant schizophrenia - A severe form of schizophrenia where symptoms persist despite adequate treatment with standard antipsychotic medications. This condition is characterized by ongoing hallucinations, delusions, and disorganized thinking that continue even when patients take their prescribed medications as directed. Patients with this form of schizophrenia experience persistent positive symptoms (such as hearing voices or having false beliefs) and negative symptoms (such as reduced emotional expression or lack of motivation). The condition typically develops after a person has shown insufficient response to at least two different antipsychotic medications taken at appropriate doses for an adequate duration.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-519836-18-00Protocol codeNW-3509/023/III/2024Estimated enrolment612 patientsSponsorNewron Pharmaceuticals S.p.A.

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