Evenamide, a Glutamate Release Modulator, as Add-On to Standard of Care in Subjects With Documented Treatment-Resistant Schizophrenia
Condition(s) studied
Investigational drug(s) / intervention(s)
Evenamide 15 mg bid: Evenamide capsules 15 mg bid for a total of 12 weeks of add-on treatment
Placebo: Matching placebo capsules bid for a total of 12 weeks of add-on treatment
Study 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
Primary outcome measure(s)
- Change from baseline to endpoint (Week 12) on the total score of the Positive and Negative Syndrome Scale (PANSS). — From Baseline to Week 12
Efficacy measured by the mean change from baseline to endpoint of Positive and Negative Syndrome Scale \[PANSS\] total score: a 30-item scale that was designed to assess various symptoms of schizophrenia each rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). - Incidence of treatment-emergent adverse events (TEAEs), AEs leading to discontinuation (ADOs), and serious AEs (SAEs). — From Baseline to 30-day Safety Follow up (12 Weeks of treament + 30-day safety follow up)
Safety and tolerability of a dose of evenamide of 15 mg bid, compared to placebo. The assessment of safety and tolerability will be based primarily on the incidence of treatment-emergent adverse events (TEAEs), AEs leading to discontinuation (ADOs), and serious AEs (SAEs).
Trial sites (19)
| Facility | City | Region | Status |
|---|---|---|---|
| UCLA DGSOM, UCLA Health, UCLA Semel Institute | Los Angeles | California | Suspended |
| University of Miami, Miller School of Medicine; Jackson Behavioral Health Hospital | Miami | Florida | Suspended |
| Grady Behavioral Health Center, -Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine | Atlanta | Georgia | Suspended |
| Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine | Baltimore | Maryland | Suspended |
| Manhattan Psychiatric Center, The Nathan Kline Institute for Psychiatric Research | New York | New York | Suspended |
| Fundación para el Estudio y Tratamiento de las Enfermedades Mentales | Buenos Aires | Buenos Aires F.D. | Active Not Recruiting |
| Help Hospital | Vijayawada | Andhra Pradesh | Recruiting |
| Gauhati Medical College and Hospital | Guwahati | Assam | Recruiting |
| Masina Hospital Trust | Mumbai | Maharashtra | Recruiting |
| All India Institute Of Medical Sciences | Nagpur | Maharashtra | Not Yet Recruiting |
| New Manak Healthcare Hospital | Navi Mumbai | Maharashtra | Recruiting |
| Ahana Hospitals LLP | Madurai | Tamil Nadu | Recruiting |
| All India Institute of Medical Sciences | Bībīnagar | Telangana | Not Yet Recruiting |
| Udyan Health Care | Lucknow | Uttar Pradesh | Recruiting |
| Seth Sukhlal Karnani Memorial Hospital | Kolkata | West Bengal | Not Yet Recruiting |
| Kuala Lumpur Hospital | Kuala Lumpur | Kuala Lumpur | Recruiting |
| Hospital Tuanku Fauziah | Kangar | Malaysia | Recruiting |
| Sentosa Hospital | Kuching | Malaysia | Recruiting |
| Sultan Abdul Halim Hospital | Sungai Petani | Malaysia | Recruiting |
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07184619 on ClinicalTrials.gov ↗ ← All trials in the USA