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Taking people in ArgentinaPhase 3

Tests evenamide added to usual medicines for treatment-resistant schizophrenia

Tests evenamide added to current antipsychotics in adults with treatment-resistant schizophrenia.

Key facts

Who runs it
Newron Pharmaceuticals SPA
Where
Buenos Aires, Córdoba, La Plata, and Rosario, ArgentinaSee the 7 sitesAlso in 4 other countries, 18 sites
Trial code
Registry title
Evenamide, a Glutamate Release Modulator, as Add-On to Standard of Care in Subjects With Documented Treatment-Resistant Schizophrenia
Status
Recruiting
Phase
Phase 3
People taking part
400 people, planned
Started
23 Jan 2026
Expected to end
31 Mar 2027
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Evenamide 15 mg bid
  • Placebo
Record updated
12 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with schizophrenia that has not responded to antipsychotic medicines. They keep taking their current antipsychotic and add evenamide or placebo for 12 weeks.

Age
18 years or older
Sex
All sexes can join.
Disease stage
Schizophrenia (DSM-5-TR) with shown resistance to antipsychotic treatment. Symptoms must be at least mild at the start, with a BPRS total score of 45 or more, a PANSS total score of 70 or more and a GAF score of 50 or less.
Earlier treatment
Must currently take at least the minimal recommended dose of one or more antipsychotics and take them as prescribed. People in hospital for a psychotic episode can join if the antipsychotic dose has been stable for 6 weeks before screening.

Main reasons for not taking part

  • Schizophreniform disorder, schizoaffective disorder, or another main psychiatric diagnosis such as bipolar disorder or major depression
  • Substance use disorder now or within the last 3 months
  • Known suicide risk or a suicide attempt in the past 2 years
  • History of neuroleptic malignant syndrome or priapism
  • Epilepsy or seizure disorder, or a seizure in the past year

The registry criteria, word for word

Show all 19 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • 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
  • History or current diagnosis of other psychiatric or behavioral disorders
  • 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
  • Known suicidal risk, or a suicide attempt within the past 2 years

Where in Argentina

Also in 4 other countries, 18 sites

  • Fundacion para el Estudio y Tratamiento de las Enfermedades MentalesBuenos Aires, ArgentinaContact: Newron PharmaceuticalsTaking people
  • Centro Especializado en Neurociencias - CENCórdoba, ArgentinaContact: Newron PharmaceuticalsTaking people
  • Centro Iternova-Consultorios en Salud MentalCórdoba, ArgentinaContact: Newron PharmaceuticalsNot yet recruiting
  • Global Psy Asociación CivilLa Plata, ArgentinaContact: Newron PharmaceuticalsNot yet recruiting
  • INSA Instituto de Neurociencias San AgustínLa Plata, ArgentinaContact: Newron PharmaceuticalsTaking people
  • CIAP-Centro de Invest y Asistencia en PsiquiatriaRosario, ArgentinaContact: Newron PharmaceuticalsTaking people
  • Fundacion Estudios ClinicosRosario, ArgentinaContact: Newron PharmaceuticalsNot yet recruiting

About the trial

What the trial wants to find out

This is a prospective, 12-week, randomized, double-blind, placebo-controlled study, designed to evaluate the efficacy, safety, and tolerability of a dose of evenamide of 15 mg bid, compared to placebo, as add-on treatment in patients with documented treatment-resistant schizophrenia (TRS) who have prospectively demonstrated inadequate response to their current stable therapeutic dose of an antipsychotic(s). Approximately 400 patients will be randomized equally (1:1) to each of the two treatment groups in this study.

The 2 groups in the trial

  • Evenamide 15 mg bidTreatment being tested

    Evenamide capsules 15 mg bid for a total of 12 weeks of add-on treatment

  • PlaceboPlacebo, for comparison

    Matching placebo capsules bid for a total of 12 weeks of add-on treatment

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Phase III, 12-week, Prospective, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center Study to Determine the Efficacy, Safety, and Tolerability of a Dose of 15 mg Bid of Evenamide as add-on in Patients With Documented Treatment-resistant Schizophrenia, Which is Not Adequately Controlled by a Stable Therapeutic Dose of the Patient's Current Antipsychotic Medication(s)
Plain-language title
Tests evenamide added to usual medicines for treatment-resistant schizophreniaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
12 November 2026