Evenamide, a Glutamate Release Modulator, as Add-On to Standard of Care in Subjects With Documented Treatment-Resistant Schizophrenia
Start Date
1/23/2026
Completion Date
12/31/2026
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 Criteria
Age Range: 18 years to No maximum
Interventions
Evenamide 15 mg bid
Placebo
Conditions
Locations
UCLA DGSOM, UCLA Health, UCLA Semel Institute
Los Angeles, California 90095
United States
University of Miami, Miller School of Medicine; Jackson Behavioral Health Hospital
Miami, Florida 33136
United States
Grady Behavioral Health Center, -Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine
Atlanta, Georgia 30322
United States
Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine
Baltimore, Maryland 21224
United States
Manhattan Psychiatric Center, The Nathan Kline Institute for Psychiatric Research
New York, New York 10035
United States
Help Hospital
Vijayawada, Andhra Pradesh 520002
India
Gauhati Medical College and Hospital
Guwahati, Assam 781032
India
Masina Hospital Trust
Mumbai, Maharashtra 400027
India
New Manak Healthcare Hospital
Navi Mumbai, Maharashtra 400706
India
Ahana Hospitals LLP
Madurai, Tamil Nadu 625020
India
Udyan Health Care
Lucknow, Uttar Pradesh 226012
India
Seth Sukhlal Karnani Memorial Hospital
Kolkata, West Bengal 700025
India
Hospital Tuanku Fauziah
Kangar, 01000
Malaysia
Sentosa Hospital
Kuching, 93250
Malaysia
Sultan Abdul Halim Hospital
Sungai Petani, 08000
Malaysia