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Study identifier: NCT07184619 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Treatment-resistant Schizophrenia  ·  Sponsor: Newron Pharmaceuticals SPA

PhasePhase 3
Planned participants400
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Newron Pharmaceuticals  ·  +39 02 610 3461  ·  info@newron.com

Always discuss trial participation with your own doctor first.

Locations (10)

UCLA DGSOM, UCLA Health, UCLA Semel InstituteLos Angeles, California, United StatesSuspended
University of Miami, Miller School of Medicine; Jackson Behavioral Health HospitalMiami, Florida, United StatesSuspended
Grady Behavioral Health Center, -Department of Psychiatry and Behavioral Sciences, Emory University School of MedicineAtlanta, Georgia, United StatesSuspended
Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of MedicineBaltimore, Maryland, United StatesSuspended
Manhattan Psychiatric Center, The Nathan Kline Institute for Psychiatric ResearchNew York, New York, United StatesSuspended
Help HospitalVijayawada, Andhra Pradesh, IndiaNot Yet Recruiting
Masina Hospital TrustMumbai, Maharashtra, IndiaRecruiting
Ahana Hospitals LLPMadurai, Tamil Nadu, IndiaRecruiting
Udyan Health CareLucknow, Uttar Pradesh, IndiaRecruiting
Seth Sukhlal Karnani Memorial HospitalKolkata, West Bengal, IndiaNot Yet Recruiting

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Source record: clinicaltrials.gov/study/NCT07184619