A Phase II/III, randomized, 4-week, placebo-controlled study, designed to determine the safety, tolerability, and efficacyof evenamide (NW-3509) in patients with chronic schizophrenia.
- Conditions
- Chronic schizophreniaMedDRA version: 20.0Level: PTClassification code 10039626Term: SchizophreniaSystem Organ Class: 10037175 - Psychiatric disordersTherapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2020-006062-36-CZ
- Lead Sponsor
- ewron Pharmaceuticals S.p.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 196
- 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 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 doseequivalent).
- 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:
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
- 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.
- 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.
In making the assessment of suicidal risk, the Investigator should take into account the ratings on the C-SSRS (based
on the past 1 month), with A ‘YES’ response on the Suicidal Ideation Item 4 or Item 5, or a ‘YES’ response on any of the
five C-SSRS Suicidal Behavior items being exclusionary.
- 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