Actively Recruiting
Evenamide, a Glutamate Release Modulator, as Add-On to Standard of Care in Subjects With Documented Treatment-Resistant Schizophrenia
Led by Newron Pharmaceuticals SPA · Updated on 2026-04-03
400
Participants Needed
5
Research Sites
31 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a prospective, 12-week, randomized, double-blind, placebo-controlled study, designed to evaluate the efficacy, safety, and tolerability of a dose of evenamide of 15 mg bid, compared to placebo, as add-on treatment in patients with documented treatment-resistant schizophrenia (TRS) who have prospectively demonstrated inadequate response to their current stable therapeutic dose of an antipsychotic(s). Approximately 400 patients will be randomized equally (1:1) to each of the two treatment groups in this study.
CONDITIONS
Official Title
Evenamide, a Glutamate Release Modulator, as Add-On to Standard of Care in Subjects With Documented Treatment-Resistant Schizophrenia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Female participants must have a negative pregnancy test at screening and baseline, not be lactating, and agree to use adequate contraception unless not of childbearing potential
- Diagnosis of schizophrenia according to current DSM-5-TR criteria
- Demonstrated treatment resistance to antipsychotics as defined by TRRIP working group
- Currently receiving a stable therapeutic dose of one or more antipsychotics as standard care
- Clinical Global Impression - Severity rating from "mildly ill" to "among the most extremely ill" at baseline
- Brief Psychiatric Rating Scale (BPRS) total score of 45 or higher at screening and baseline
- Positive and Negative Syndrome Scale (PANSS) total score of 70 or higher at baseline
- Global Assessment of Functioning (GAF) score of 50 or lower
- Adherence to prescribed antipsychotic treatment
- Provided written informed consent before participating in the study
You will not qualify if you...
- Diagnosis of schizophreniform disorder, schizoaffective disorder, bipolar disorder, major depressive disorder, or other primary psychiatric diagnoses
- Substance Use Disorder within three months before study entry or current diagnosis
- Current psychosis episode severity requiring hospitalization for stabilization unless 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 suicide attempt within the past 2 years
- History of neuroleptic malignant syndrome or priapism
- Any disease or medical condition that may affect safety or study evaluations
- History or current diagnosis of epilepsy or seizure disorder, seizure within the past year, or repeated drug-induced seizures
AI-Screening
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Trial Site Locations
Total: 5 locations
1
UCLA DGSOM, UCLA Health, UCLA Semel Institute
Los Angeles, California, United States, 90095
Actively Recruiting
2
University of Miami, Miller School of Medicine; Jackson Behavioral Health Hospital
Miami, Florida, United States, 33136
Not Yet Recruiting
3
Grady Behavioral Health Center, -Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine
Atlanta, Georgia, United States, 30322
Not Yet Recruiting
4
Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21224
Actively Recruiting
5
Manhattan Psychiatric Center, The Nathan Kline Institute for Psychiatric Research
New York, New York, United States, 10035
Actively Recruiting
Research Team
N
Newron Pharmaceuticals
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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