Evenamide, a Glutamate Release Modulator, as Add-On to Standard of Care in Subjects With Documented Treatment-Resistant Schizophrenia
Recruiting now · Phase 3 · Has a placebo group
Conditions studied: Treatment-resistant Schizophrenia
In brief
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.
Key facts
- Study ID
- NCT07184619
- Run by
- Newron Pharmaceuticals SPA
- People needed
- 400
- Starts
- 2026-01-23
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2026-07-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Sultan Abdul Halim Hospital — Sungai Petani, Malaysia (enrolling)
- Masina Hospital Trust — Mumbai, Maharashtra, India (enrolling)
- New Manak Healthcare Hospital — Navi Mumbai, Maharashtra, India (enrolling)
- Ahana Hospitals LLP — Madurai, Tamil Nadu, India (enrolling)
- Udyan Health Care — Lucknow, Uttar Pradesh, India (enrolling)
- Hospital Tuanku Fauziah — Kangar, Malaysia (enrolling)
- Sentosa Hospital — Kuching, Malaysia (enrolling)
- Help Hospital — Vijayawada, Andhra Pradesh, India (enrolling)
- Gauhati Medical College and Hospital — Guwahati, Assam, India (enrolling)
- University of Miami, Miller School of Medicine; Jackson Behavioral Health Hospital — Miami, Florida, United States
- Grady Behavioral Health Center, -Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine — Atlanta, Georgia, United States
- Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine — Baltimore, Maryland, United States
- Manhattan Psychiatric Center, The Nathan Kline Institute for Psychiatric Research — New York, New York, United States
- Seth Sukhlal Karnani Memorial Hospital — Kolkata, West Bengal, India
- UCLA DGSOM, UCLA Health, UCLA Semel Institute — Los Angeles, California, United States
Full record on ClinicalTrials.gov
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