Tests evenamide added to usual medicines for treatment-resistant schizophrenia
Tests evenamide added to current antipsychotics in adults with treatment-resistant schizophrenia.
Plain-language title generated from the registry record
Registry title: Evenamide, a Glutamate Release Modulator, as Add-On to Standard of Care in Subjects With Documented Treatment-Resistant Schizophrenia
Key facts
- Where
- Bībīnagar, Guwahati, Kolkata, Lucknow, Madurai, Mumbai, Nagpur, Navi Mumbai, and Vijayawada, IndiaSee the 9 sites
- Phase
- Phase 3
AI summary: who the study is looking for
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
Read by machine on 11 November 2026.
Where in India
- All India Institute of Medical SciencesBībīnagar, IndiaNot yet recruiting
- Gauhati Medical college and HospitalGuwahati, IndiaTaking people
- Seth Sukhlal Karnani Memorial HospitalKolkata, IndiaNot yet recruiting
- Udyan Health CareLucknow, IndiaTaking people
- Ahana Hospitals LLPMadurai, IndiaTaking people
- Masina Hospital TrustMumbai, IndiaTaking people
- All India Institute of Medical SciencesNagpur, IndiaNot yet recruiting
- New Manak Healthcare HospitalNavi Mumbai, IndiaTaking people
- Help HospitalVijayawada, IndiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Newron Pharmaceuticals SPA
- Trial code
- NCT07184619
- Record updated
- 10 September 2026
- Original description
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.Read full original descriptionShow less
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)
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.
Inclusion: 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.
Exclusion: 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.