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

Phase 1

• Conditions: Chronic schizophrenia; MedDRA version: 20.0Level: PTClassification code 10039626Term: SchizophreniaSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2020-006062-36-EE
• Lead Sponsor: ewron Pharmaceuticals S.p.A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-27
• Last Update Posted: 24 June 2024

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 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:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 160
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

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.
- 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