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

RecruitingPhase 3Ages 18 Years - anyAllNewron Pharmaceuticals SPA
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Key Inclusion Criteria: * 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 Criteria: * 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.
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What it tests

  • Evenamide 15 mg bid
  • Placebo
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Where

19 sites
UCLA DGSOM, UCLA Health, UCLA Semel Institute
Los Angeles, United States
University of Miami, Miller School of Medicine; Jackson Behavioral Health Hospital
Miami, United States
Grady Behavioral Health Center, -Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine
Atlanta, United States
Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine
Baltimore, United States
Manhattan Psychiatric Center, The Nathan Kline Institute for Psychiatric Research
New York, United States
Fundación para el Estudio y Tratamiento de las Enfermedades Mentales
Buenos Aires, Argentina
Help Hospital
Vijayawada, India
Gauhati Medical College and Hospital
Guwahati, India

…and 11 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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