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)

Newron Pharmaceuticals SPA

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, 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

Age range: 18+ years
Sex: All
Healthy volunteers

Detailed 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) r…

Interventions

Drug
Evenamide 15 mg bid
Evenamide capsules 15 mg bid for a total of 12 weeks of add-on treatment
Drug
Placebo
Matching placebo capsules bid for a total of 12 weeks of add-on treatment

Locations (19)

UCLA DGSOM, UCLA Health, UCLA Semel Institute
Los Angeles, California
University of Miami, Miller School of Medicine; Jackson Behavioral Health Hospital
Miami, Florida
Grady Behavioral Health Center, -Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine
Atlanta, Georgia
Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine
Baltimore, Maryland
Manhattan Psychiatric Center, The Nathan Kline Institute for Psychiatric Research
New York, New York
Fundación para el Estudio y Tratamiento de las Enfermedades Mentales
Buenos Aires, Buenos Aires F.D.