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Evenamide for Treatment-Resistant Schizophrenia

This study is testing a medication called evenamide for people with treatment-resistant schizophrenia (schizophrenia that hasn't responded well to other treatments). You might be able to join if you are 18 or older, have schizophrenia that meets specific criteria, and are currently taking an antipsychotic medication that isn't fully effective. The study will compare evenamide 15 mg twice a day to a placebo (an inactive pill) over 12 weeks. Researchers will measure how much your symptoms change using a scale called the Positive and Negative Syndrome Scale (PANSS), and they will also track any side effects you might experience. About 400 people are expected to participate.

Study design
This is a 12-week, randomized, double-blind, placebo-controlled study involving approximately 400 participants. Participants will be randomly assigned to receive either evenamide or a placebo.
What's involved
You would take either evenamide or a placebo twice a day for 12 weeks. There will be safety follow-up for 30 days after treatment ends.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for safety for 30 days after the 12 weeks of treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07184619

Evenamide, a Glutamate Release Modulator, as Add-On to Standard of Care in Subjects With Documented Treatment-Resistant Schizophrenia

Recruiting
PHASE3Ages 18+InterventionalTreatment
Newron Pharmaceuticals SPA
~400 participants
Updated 2026-07-30 on ClinicalTrials.gov
What's tested:Evenamide 15 mg bidPlacebo

At a glance

Recruiting sites
9 of 15 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from baseline to endpoint (Week 12) on the total score of the Positive and Negative Syndrome Scale (PANSS).
Measured over From Baseline to Week 12
+1 more outcome measured

Conditions

Treatment-resistant Schizophrenia

Explore related trials

Schizophrenia

Where it's being run

15 sites across 12 states
Malaysia3
Maharashtra2
California1
Florida1
Georgia1
Maryland1
New York1
Andhra Pradesh1

Study leadership

  • Ravi Anand, MD · STUDY_DIRECTOR · Newron Pharmaceuticals

Who to contact

Newron Pharmaceuticals
[email protected]
+39 02 610 3461
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age - 18 years, or older.
If female, the subject has a negative pregnancy test at the screening visit and at baseline, is not lactating, and agrees to use adequate contraception, unless not of childbearing potential.
Meets current DSM-5-TR criteria for schizophrenia.
Has shown treatment-resistance to antipsychotics as per TRRIP working group definition (Howes et al., 2017).
Currently receiving "standard of care" therapy of a minimal recommended therapeutic dose of one or more antipsychotic(s).
Has a Clinical Global Impression - Severity of disease (CGI-S) rating of "mildly ill" to "among the most extremly ill" at baseline.
Has a BPRS total score ≥ 45 at screening and baseline.
Has a PANSS total score ≥ 70 at baseline.
Has a Global Assessment of Functioning (GAF) scale total score ≤ 50.
Adherence to prescribed antipsychotic treatment.
Patient has provided written informed consent prior to participating in the study.

Exclusion

Current DSM-5-TR diagnosis of schizophreniform disorder, schizoaffective disorder, or other primary psychiatric diagnosis, such as bipolar disorder or major depressive disorder
History (within three months of study entry) or current diagnosis of "Substance Use Disorder" as defined by the DSM-5-TR criteria.
Severity of current episode of psychosis requires that the patient be hospitalized to stabilize the severity of his/her psychotic symptoms. However, these patients may qualify for the study provided their antipsychotic dose has been stable for 6 weeks prior to screening.
History or current diagnosis of other psychiatric or behavioral disorders.
Known suicidal risk, or a suicide attempt within the past 2 years.
History of neuroleptic malignant syndrome or priapism.
Disease/medical condition of any type that may impact the patient's safety or interfere with any of the study evaluations.
History or current diagnosis of epilepsy or seizure disorder, or occurrence of a seizure within the past year, or repeated drug-induced seizures.

What this trial measures

  • Change from baseline to endpoint (Week 12) on the total score of the Positive and Negative Syndrome Scale (PANSS).From Baseline to Week 12

    Efficacy measured by the mean change from baseline to endpoint of Positive and Negative Syndrome Scale \[PANSS\] total score: a 30-item scale that was designed to assess various symptoms of schizophrenia each rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology).

  • Incidence of treatment-emergent adverse events (TEAEs), AEs leading to discontinuation (ADOs), and serious AEs (SAEs).From Baseline to 30-day Safety Follow up (12 Weeks of treament + 30-day safety follow up)

    Safety and tolerability of a dose of evenamide of 15 mg bid, compared to placebo. The assessment of safety and tolerability will be based primarily on the incidence of treatment-emergent adverse events (TEAEs), AEs leading to discontinuation (ADOs), and serious AEs (SAEs).