study to determine the safety, tolerability, and efficacy of evenamide in patients with chronic schizophrenia

Conditions: Schizophrenia

Summary: this 4-week study will evaluate the safety, tolerability and preliminary evidence of efficacy of evenamide (7.5,and 15 mg and placebo, bid) treatment in outpatients with chronic schizophrenia.

this is a prospective, 4-week, randomized, double-blind, placebo-controlled, study designed to evaluate the safety, tolerability, eeg effects, and preliminary efficacy of two fixed oral doses of evenamide of 7.5 mg and 15 mg bid (15 and 30 mg/day) in outpatients with chronic schizophrenia who are receiving treatment at constant doses of one of the following atypical antipsychotics: aripiprazole, clozapine, quetiapine, olanzapine, paliperidone or risperidone. approximately 120 patients will be randomized in a 1:1:1 ratio to receive either evenamide 7.5 or 15 mg, or placebo, given bid.

Eligibility criteria:
inclusion criteria: demographics * age - 18 years, or older * sex - male, or non-childbearing potential female unless practicing adequate contraception psychiatric * has a current diagnosis of schizophrenia in accordance with dsm-5. * has been treated with antipsychotics for at least 2 years. * has a total score on the panss \< 80. * has a clinical global impression - severity of disease (cgi-s) rating of mildly, moderately or moderately severely ill (score of 3, 4 or 5). * needs antipsychotic treatment and is currently receiving a stable dose (minimally for 4 weeks prior to screening) of aripiprazole, clozapine, quetiapine, olanzapine, paliperidone, or risperidone (at least 2 mg risperidone dose-equivalent) * current symptoms have been stably present for at least one month procedural * patient resides at home or in a residential care facility * if taking clozapine, patient agrees to blood monitoring exclusion criteria: psychiatric * severity of current episode of psychosis requires that the patient be hospitalized. patients who are chronically hospitalized or in psychiatric day-care, whose hospitalization is for logistic reasons and not due to the severity of their illness, will be eligible for the study. * severity of psychosis is rated severe or higher (cgi-s of 6 or greater). * known suicidal risk. a "yes" response on the c-ssrs suicidal ideation item 4 or item 5, or a "yes" response on any of the five c-ssrs suicidal behavior items, at screening, or a suicide attempt within the past 6 months, excludes the patient from the study. * patients with a diagnosis of treatment resistance * history of neuroleptic malignant syndrome, priapism. * current moderate or severe tardive dyskinesia. medical status * abnormal epileptiform phenomena (3 per second spike and slow wave discharges) observed on screening eeg. history or current diagnosis of epilepsy or seizure disorder (other than febrile seizures in childhood) * insulin-dependent diabetes mellitus * history or current diagnosis of any neurodegenerative illnesses * loss of 500 ml or more of blood during the 3-month period before study enrollment, e.g. as a donor cardiovascular * a current diagnosis of severe or unstable cardiovascular disease * any clinically significant ecg abnormality * abnormal vital signs laboratory abnormalities * clinically significant abnormalities in routine laboratory examinations * history and/or presence of hepatitis b and/or c * positive results from the hiv serology. * positive results of the drug and alcohol tests * clinically significant or unstable hypothyroidism or hyperthyroidism concomitant therapy * treatment with ssris that are moderate/potent inhibitors of cyp2d6 (e.g. fluoxetine) * treatment with drugs capable of inducing/inhibiting hepatic enzyme metabolism * current treatment with sodium channel blockers * exposure to any investigational drug within 5 weeks or 5 half-lives (whichever is longer) prior to screening * a known exaggerated pharmacological sensitivity or hypersensitivity to drugs similar to evenamide (e.g. lamotrigine, carbamazepine, oxcarbazepine, topiramate, etc.), or any components of the evenamide or matching placebo capsules * treatment with a drug or treatment known to cause major organ system toxicity, e.g. tamoxifen, within 4 weeks, or received radiation therapy or a drug with cytotoxic potential, e.g. chemotherapy, during the past year * electroconvulsive therapy (ect) or treatment with a transcranial magnetic stimulation (tms) device within 6 months prior to screening