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.
Age - 18 years, or older.
If female, the subject has a negative pregnancy test at the screening visit and at baseline, is not lactating, and agrees to use adequate contraception, unless not of childbearing potential.
Meets current DSM-5-TR criteria for schizophrenia.
Has shown treatment-resistance to antipsychotics as per TRRIP working group definition (Howes et al., 2017).
Current DSM-5-TR diagnosis of schizophreniform disorder, schizoaffective disorder, or other primary psychiatric diagnosis, such as bipolar disorder or major depressive disorder
History (within three months of study entry) or current diagnosis of "Substance Use Disorder" as defined by the DSM-5-TR criteria.
Severity of current episode of psychosis requires that the patient be hospitalized to stabilize the severity of his/her psychotic symptoms. However, these patients may qualify for the study provided their antipsychotic dose has been stable for 6 weeks prior to screening.
History or current diagnosis of other psychiatric or behavioral disorders.
Parallel
Evenamide 15 mg bid
DrugEvenamide capsules 15 mg bid for a total of 12 weeks of add-on treatment
Placebo
DrugMatching placebo capsules bid for a total of 12 weeks of add-on treatment
Change 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).
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).
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.
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'.
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).
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.
Change from baseline to endpoint (Week 12) on the Negative 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: this is a 7-item subscale that was designed to assess negative symptoms of schizophrenia each rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology).
Change from baseline to endpoint (Week 12) on the Calgary Depression Scale for Schizophrenia (CDSS).
Efficacy measured by the mean change from baseline to endpoint on the CDSS: a 9-item, observer-rated, semi-structured, goal-directed interview, validated for diagnosing depression in patients with schizophrenia. Each item is scored between "Absent" (0) to "Severe" (3), based on operational criteria.
Change from baseline to endpoint (Week 12) on the Global Assessment of Functioning (GAF) scale.
Efficacy measured by the mean change from baseline to endpoint on the GAF scale ranging from 0 (inadequate information) to 100 (superior functioning), and is divided into 10-point ranges of functioning.
Change from baseline to endpoint (Week 12) on the Medication Satisfaction Questionnaire (MSQ).
Efficacy measured by the mean change from baseline to endpoint on the Medication Satisfaction Questionnaire (MSQ) which is a single-item, 7-point scale for patients with schizophrenia to rate their satisfaction with their antipsychotic medication ranging from "extremely dissatisfied" (1) to "extremely satisfied" (7).
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