A Phase II/III, randomized, 4-week, placebo-controlled, multiple-dose study, designed to determine the safety, tolerability, and efficacy of two doses of evenamide (NW-3509) in patients with chronic schizophrenia.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 260

Inclusion Criteria

- Has a current diagnosis of schizophrenia in accordance with DSM-5. Other Axis-I disorders may be present only as lifetime diagnoses if they are not relevant to the current episode of schizophrenia. [see Exclusion criteria]
- Has been treated with antipsychotics for at least 2 years.
- Has a total score on the PANSS >70 and =85.
- Has a score of 4 (moderate) or more on at least 2 of the following 4 core symptoms of psychosis: conceptual disorganization, hallucinatory behavior, suspiciousness and unusual thought content; and a total score of at least 20 on the combined total of the 4 core items and the following 3 additional positive symptoms items: grandiosity, hostility, and excitement (based on the PANSS descriptions).
- Has a Clinical Global Impression – Severity of disease (CGI-S) rating of moderately, moderately severely, or severely ill (score of 4, 5 or 6).
- 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.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 98
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 98

Exclusion Criteria

- DSM-5 diagnosis of schizophreniform disorder (295.40), schizoaffective disorder (295.70), or other primary psychiatric diagnosis, such as bipolar disorder or major depressive disorder. (Comorbid depression will be assessed at screening and baseline using the Calgary Depression Scale for Schizophrenia [CDSS]. A score of 7 or higher will be exclusionary.)
- History (within three months of study entry) or current diagnosis of Substance Use Disorder as defined by the DSM-5 criteria, with a severity of ‘moderate’ or ‘severe’, or patient is currently abusing drugs or alcohol or has done so in the past year. A history of nicotine or caffeine dependence is acceptable
- 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.
- Has a score of 6 (severe) or higher on 2 or more of the following 4 core symptoms of psychosis: conceptual disorganization, hallucinatory behavior, suspiciousness and unusual thought content (derived from the PANSS).
- Severity of psychosis is rated severe or higher (CGI-S of 7).
- Known suicidal risk. Patients who have exhibited suicidal behaviour within the past 6 months, as indicated by an actual attempt, interrupted attempt, aborted attempt, or preparatory acts will be excluded from participating in the trial.
- Treatment resistant” defined significant persistent symptoms of schizophrenia after adequate doses of two standard antipsychotic medications (from two different chemical classes, including at least one atypical antipsychotic) following 6 weeks of treatment with each at adequate doses. Treatment resistant patients on clozapine for at least 6 months will be permitted if they have shown minimal improvement in the Investigator’s judgement.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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