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).

This is a 12-week double-blind, placebo-controlled inpatient and outpatient study to evaluate the efficacy, safety, and tolerability of evenamide 15 mg compared to placebo as add on treatment in patients with documented treatment resistant schizophrenia (TRS), who have demonstrated inadequate response to their current antipsychotic. There are 8 subject visits (Screening, Baseline/Day 1, Week 2, Week 4, Week 8, Week 12,7-day safety follow-up, and 30-day safety follow-up and extended post treatment) for the study.

Study Length

Disorder/Condition

Study Description (brief)

This is a 12-week double-blind, placebo-controlled inpatient and outpatient study to evaluate the efficacy, safety, and tolerability of evenamide 15 mg compared to placebo as add on treatment in patients with documented treatment resistant schizophrenia (TRS), who have demonstrated inadequate response to their current antipsychotic. There are 8 subject visits (Screening, Baseline/Day 1, Week 2, Week 4, Week 8, Week 12,7-day safety follow-up, and 30-day safety follow-up and extended post treatment) for the study.

Study Contact

Mersad Redzepagic at Mersad.Redzepagic@nki.rfmh.org, or Benedicto Parker at Benedicto.Parker@nki.rfmh.org and 212-866-2690.

Study Location