Status:
NOT_YET_RECRUITING
Evenamide, a Glutamate Release Modulator, as Add-On to Standard of Care in Subjects With Documented Treatment-Resistant Schizophrenia
Lead Sponsor:
Newron Pharmaceuticals SPA
Conditions:
Treatment-resistant Schizophrenia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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...
Eligibility Criteria
Inclusion
- Key
- 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.
- Key
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.
Key Trial Info
Start Date :
October 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT07184619
Start Date
October 15 2025
End Date
September 1 2026
Last Update
October 1 2025
Active Locations (5)
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1
UCLA DGSOM, UCLA Health, UCLA Semel Institute
Los Angeles, California, United States, 90095
2
University of Miami, Miller School of Medicine; Jackson Behavioral Health Hospital
Miami, Florida, United States, 33136
3
Grady Behavioral Health Center, -Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine
Atlanta, Georgia, United States, 30322
4
Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21224