Phase 3 Study of Evenamide 15 mg Twice Daily as Add-On Treatment for Adults With Treatment-Resistant Schizophrenia

What this Trial Is About

Researchers are evaluating the effects of evenamide as an additional treatment for patients with treatment-resistant schizophrenia who have not responded well to their current stable antipsychotic medications. This Phase III trial aims to compare the safety, tolerability, and effectiveness of adding evenamide at a dose of 15 mg twice daily versus a placebo over a 12-week period. The study plans to enroll about 400 participants, randomly assigning them equally into two groups. Participants will receive either evenamide capsules or matching placebo capsules twice daily as an add-on to their existing antipsychotic treatment for 12 weeks. The study is designed as a randomized, double-blind, placebo-controlled trial to ensure unbiased assessment of outcomes. After the treatment period, there is a 30-day safety follow-up to monitor adverse events. During the study, participants will undergo evaluations including the Positive and Negative Syndrome Scale PANSS to assess symptom changes, and monitoring for treatment-emergent adverse events. Additional assessments include severity of illness, global improvement ratings, social performance, and quality of life questionnaires conducted from baseline through week 12. Safety is closely monitored throughout the treatment and follow-up periods. The total participation lasts for approximately 12 weeks plus the 30-day safety follow-up.

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