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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
400
Evenamide capsules 15 mg bid for a total of 12 weeks of add-on treatment
Matching placebo capsules bid for a total of 12 weeks of add-on treatment
UCLA DGSOM, UCLA Health, UCLA Semel Institute
Los Angeles, California, United States
RECRUITINGUniversity of Miami, Miller School of Medicine; Jackson Behavioral Health Hospital
Miami, Florida, United States
NOT_YET_RECRUITINGGrady Behavioral Health Center, -Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine
Atlanta, Georgia, United States
NOT_YET_RECRUITINGDepartment of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine
Baltimore, Maryland, United States
NOT_YET_RECRUITINGManhattan Psychiatric Center, The Nathan Kline Institute for Psychiatric Research
New York, New York, United States
NOT_YET_RECRUITINGChange from baseline to endpoint (Week 12) on the total score of the Positive and Negative Syndrome Scale (PANSS).
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).
Time frame: From Baseline to Week 12
Incidence of treatment-emergent adverse events (TEAEs), AEs leading to discontinuation (ADOs), and serious AEs (SAEs).
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).
Time frame: From Baseline to 30-day Safety Follow up (12 Weeks of treament + 30-day safety follow up)
Change from baseline to endpoint (Week 12) on the Clinical Global Impression - Severity of illness (CGI-S) score.
Efficacy measured by the mean change from baseline to endpoint on the Clinical Global Impression Severity of Illness (CGI-S) scale: a 7-point scale ranging from 1 (no symptoms) to 7 (very severe) to assess the severity of a subject's condition.
Time frame: From Baseline to Week 12
Proportion of patients rated as 'improved' on the CGI-C at endpoint (Week 12).
Efficacy measured by Clinical Global Impression of Change \[CGI-C\]: a 7-point scale, ranging from 1 (very much improved) to 7 (very much worse), with a score of 4 indicating "no change". Patients with ratings of 1,2 or 3 are considered as 'improved'.
Time frame: Week 12
Change from baseline to endpoint (Week 12) on the Positive Symptoms sub-scale score of the PANSS.
Efficacy measured by the mean change from baseline to endpoint on the Positive subscale score of the PANSS: a 7-item subscale designed to assess positive symptoms of schizophrenia each rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology).
Time frame: From Baseline to Week 12
Change from baseline to endpoint (Week 12) on the Personal and Social Performance (PSP) scale.
Efficacy measured by the mean change from baseline to endpoint on the PSP scale: a 100-point single-item rating scale subdivided into 10 equal intervals that designed to assess the routine social functioning of patients with psychiatric disorders.
Time frame: From Baseline to Week 12
Change from baseline to endpoint (Week 12) on the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form scale (Q-LES-Q-SF).
Efficacy measured by the mean change from baseline to endpoint on the total score of the Quality of Life Enjoyment and Satisfaction Questionnaire: a 16-item scale, each rated from 1 (very poor) to 5 (very good).
Time frame: From Baseline to Week 12
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