Evenamide added to standard antipsychotic treatment for treatment-resistant schizophrenia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this phase 3, double-blind, placebo-controlled trial, about 400 adults with documented treatment-resistant schizophrenia who remain symptomatic on stable antipsychotic therapy are randomized 1:1 to receive evenamide 15 mg twice daily or placebo for 12 weeks as an add-on. The study measures symptom change, safety, and tolerability using standardized scales and clinician ratings. Key enrollment requirements include DSM-5-TR schizophrenia, prior inadequate response per the TRRIP definition, and minimum baseline thresholds on PANSS and BPRS. Participants must remain on their prescribed antipsychotic regimen and provide informed consent.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

* 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).
* Currently receiving "standard of care" therapy of a minimal recommended therapeutic dose of one or more antipsychotic(s).
* Has a Clinical Global Impression - Severity of disease (CGI-S) rating of "mildly ill" to "among the most extremly ill" at baseline.
* Has a BPRS total score ≥ 45 at screening and baseline.
* Has a PANSS total score ≥ 70 at baseline.
* Has a Global Assessment of Functioning (GAF) scale total score ≤ 50.
* Adherence to prescribed antipsychotic treatment.
* Patient has provided written informed consent prior to participating in the study.

Key Exclusion Criteria:

* 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.
* Known suicidal risk, or a suicide attempt within the past 2 years.
* History of neuroleptic malignant syndrome or priapism.
* Disease/medical condition of any type that may impact the patient's safety or interfere with any of the study evaluations.
* History or current diagnosis of epilepsy or seizure disorder, or occurrence of a seizure within the past year, or repeated drug-induced seizures.

Where it's running

• Help Hospital
  Vijayawada, Andhra Pradesh, India Recruiting
• Gauhati Medical College and Hospital
  Guwahati, Assam, India Recruiting
• Masina Hospital Trust
  Mumbai, Maharashtra, India Recruiting
• New Manak Healthcare Hospital
  Navi Mumbai, Maharashtra, India Recruiting
• Ahana Hospitals LLP
  Madurai, Tamil Nadu, India Recruiting
• Udyan Health Care
  Lucknow, Uttar Pradesh, India Recruiting

Study contacts

• Study coordinator: Newron Pharmaceuticals
• Email: info@newron.com
• Phone: +39 02 610 3461

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.