A Phase 3 interventional study of Evenamide 15 mg bid and Placebo in Treatment-resistant Schizophrenia, sponsored by Newron Pharmaceuticals SPA. Recruiting at 19 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Newron Pharmaceuticals SPA · Phase 3, Interventional, and Treatment
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.
53 studies on the registry are indexed under Schizophrenia, Treatment-Resistant; 22 are open to participants now.
This study's planned enrollment of 400 is above the median of 60 across 46 interventional studies indexed under Schizophrenia, Treatment-Resistant.
Browse Schizophrenia, Treatment-Resistant studies →Newron Pharmaceuticals SPA is the lead sponsor of 22 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Evenamide capsules 15 mg bid for a total of 12 weeks of add-on treatment
Drug: Evenamide 15 mg bid
Matching placebo capsules bid for a total of 12 weeks of add-on treatment
Drug: Placebo
Evenamide capsules 15 mg bid for a total of 12 weeks of add-on treatment
Matching placebo capsules bid for a total of 12 weeks of add-on treatment
Change from baseline to endpoint (Week 12) on the total score of the Positive and Negative Syndrome Scale (PANSS).
Efficacy measured by the mean change from baseline to endpoint of Positive and Negative Syndrome Scale \[PANSS\] total score: a 30-item scale that was designed to assess various symptoms of schizophrenia each rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology).
Time frame: From Baseline to Week 12
Incidence of treatment-emergent adverse events (TEAEs), AEs leading to discontinuation (ADOs), and serious AEs (SAEs).
Safety and tolerability of a dose of evenamide of 15 mg bid, compared to placebo. The assessment of safety and tolerability will be based primarily on the incidence of treatment-emergent adverse events (TEAEs), AEs leading to discontinuation (ADOs), and serious AEs (SAEs).
Time frame: From Baseline to 30-day Safety Follow up (12 Weeks of treament + 30-day safety follow up)
Change from baseline to endpoint (Week 12) on the Clinical Global Impression - Severity of illness (CGI-S) score.
Efficacy measured by the mean change from baseline to endpoint on the Clinical Global Impression Severity of Illness (CGI-S) scale: a 7-point scale ranging from 1 (no symptoms) to 7 (very severe) to assess the severity of a subject's condition.
Time frame: From Baseline to Week 12
Proportion of patients rated as 'improved' on the CGI-C at endpoint (Week 12).
Efficacy measured by Clinical Global Impression of Change \[CGI-C\]: a 7-point scale, ranging from 1 (very much improved) to 7 (very much worse), with a score of 4 indicating "no change". Patients with ratings of 1,2 or 3 are considered as 'improved'.
Time frame: Week 12
Change from baseline to endpoint (Week 12) on the Positive Symptoms sub-scale score of the PANSS.
Efficacy measured by the mean change from baseline to endpoint on the Positive subscale score of the PANSS: a 7-item subscale designed to assess positive symptoms of schizophrenia each rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology).
Time frame: From Baseline to Week 12
Change from baseline to endpoint (Week 12) on the Personal and Social Performance (PSP) scale.
Efficacy measured by the mean change from baseline to endpoint on the PSP scale: a 100-point single-item rating scale subdivided into 10 equal intervals that designed to assess the routine social functioning of patients with psychiatric disorders.
Time frame: From Baseline to Week 12
Change from baseline to endpoint (Week 12) on the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form scale (Q-LES-Q-SF).
Efficacy measured by the mean change from baseline to endpoint on the total score of the Quality of Life Enjoyment and Satisfaction Questionnaire: a 16-item scale, each rated from 1 (very poor) to 5 (very good).
Time frame: From Baseline to Week 12
Change from baseline to endpoint (Week 12) on the Negative Symptoms sub-scale score of the PANSS.
Efficacy measured by the mean change from baseline to endpoint on the Positive subscale score of the PANSS: this is a 7-item subscale that was designed to assess negative symptoms of schizophrenia each rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology).
Time frame: From Baseline to Week 12.
Change from baseline to endpoint (Week 12) on the Calgary Depression Scale for Schizophrenia (CDSS).
Efficacy measured by the mean change from baseline to endpoint on the CDSS: a 9-item, observer-rated, semi-structured, goal-directed interview, validated for diagnosing depression in patients with schizophrenia. Each item is scored between "Absent" (0) to "Severe" (3), based on operational criteria.
Time frame: From Baseline to Week 12
Change from baseline to endpoint (Week 12) on the Global Assessment of Functioning (GAF) scale.
Efficacy measured by the mean change from baseline to endpoint on the GAF scale ranging from 0 (inadequate information) to 100 (superior functioning), and is divided into 10-point ranges of functioning.
Time frame: From Baseline to Week 12.
Change from baseline to endpoint (Week 12) on the Medication Satisfaction Questionnaire (MSQ).
Efficacy measured by the mean change from baseline to endpoint on the Medication Satisfaction Questionnaire (MSQ) which is a single-item, 7-point scale for patients with schizophrenia to rate their satisfaction with their antipsychotic medication ranging from "extremely dissatisfied" (1) to "extremely satisfied" (7).
Time frame: From Baseline to Week 12
Change from baseline to endpoint (Week 12) on the Cognitive Test Battery.
Efficacy measured by the mean change from baseline on the scores of the Cognitive Test Battery. This includes: the Digit Symbol Substitution test, Trail Making Test (Parts A and B), d2 Test of Attention, and verbal fluency measures.
Time frame: From Baseline to Week 12
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Plan to share: Undecided
Started Jan 2026 (actual). Primary completion is estimated for Mar 2027, 14 months after the start.
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Studies of the drug tested here: Evenamide
Schizophrenia, Treatment-Resistant →