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

NCT07184619

RecruitingPhase 3

Sponsor: Newron Pharmaceuticals SPA

Conditions: Treatment-resistant Schizophrenia

Interventions: Evenamide 15 mg bid, Placebo

Countries: United States, India, Malaysia

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (15)

Los Angeles, California, United States
Miami, Florida, United States
Atlanta, Georgia, United States
Baltimore, Maryland, United States
New York, New York, United States
Vijayawada, Andhra Pradesh, India
Guwahati, Assam, India
Mumbai, Maharashtra, India
Navi Mumbai, Maharashtra, India
Madurai, Tamil Nadu, India
Lucknow, Uttar Pradesh, India
Kolkata, West Bengal, India
Kangar, Malaysia
Kuching, Malaysia
Sungai Petani, Malaysia