Tests evenamide added to usual medicines for treatment-resistant schizophrenia
Tests evenamide added to current antipsychotics in adults with treatment-resistant schizophrenia.
Plain-language title generated from the registry record
Registry title: Evenamide, a Glutamate Release Modulator, as Add-On to Standard of Care in Subjects With Documented Treatment-Resistant Schizophrenia
Key facts
- Where
- Buenos Aires, ArgentinaSee the site
- Phase
- Phase 3
Where in Argentina
- Fundacion para el Estudio y Tratamiento de las Enfermedades MentalesBuenos Aires, ArgentinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Newron Pharmaceuticals SPA
- Trial code
- NCT07184619
- Record updated
- 10 September 2026
- Original description
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.Read full original descriptionShow less
A Phase III, 12-week, Prospective, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center Study to Determine the Efficacy, Safety, and Tolerability of a Dose of 15 mg Bid of Evenamide as add-on in Patients With Documented Treatment-resistant Schizophrenia, Which is Not Adequately Controlled by a Stable Therapeutic Dose of the Patient's Current Antipsychotic Medication(s)
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.
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: 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; 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; History or current diagnosis of other psychiatric or behavioral disorders; 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; Known suicidal risk, or a suicide attempt within the past 2 years.