Evenamide 15 mg bid: Evenamide capsules 15 mg bid for a total of 12 weeks of add-on treatment
Placebo: Matching placebo capsules bid for a total of 12 weeks of add-on treatment
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Change from baseline to endpoint (Week 12) on the total score of the Positive and Negative Syndrome Scale (PANSS). — From Baseline to Week 12 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).
Incidence of treatment-emergent adverse events (TEAEs), AEs leading to discontinuation (ADOs), and serious AEs (SAEs). — From Baseline to 30-day Safety Follow up (12 Weeks of treament + 30-day safety follow up) 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).
Trial sites (19)
Facility
City
Region
Status
UCLA DGSOM, UCLA Health, UCLA Semel Institute
Los Angeles
California
Suspended
University of Miami, Miller School of Medicine; Jackson Behavioral Health Hospital
Miami
Florida
Suspended
Grady Behavioral Health Center, -Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine
Atlanta
Georgia
Suspended
Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine
Baltimore
Maryland
Suspended
Manhattan Psychiatric Center, The Nathan Kline Institute for Psychiatric Research
New York
New York
Suspended
Fundación para el Estudio y Tratamiento de las Enfermedades Mentales
Buenos Aires
Buenos Aires F.D.
Active Not Recruiting
Help Hospital
Vijayawada
Andhra Pradesh
Recruiting
Gauhati Medical College and Hospital
Guwahati
Assam
Recruiting
Masina Hospital Trust
Mumbai
Maharashtra
Recruiting
All India Institute Of Medical Sciences
Nagpur
Maharashtra
Not Yet Recruiting
New Manak Healthcare Hospital
Navi Mumbai
Maharashtra
Recruiting
Ahana Hospitals LLP
Madurai
Tamil Nadu
Recruiting
All India Institute of Medical Sciences
Bībīnagar
Telangana
Not Yet Recruiting
Udyan Health Care
Lucknow
Uttar Pradesh
Recruiting
Seth Sukhlal Karnani Memorial Hospital
Kolkata
West Bengal
Not Yet Recruiting
Kuala Lumpur Hospital
Kuala Lumpur
Kuala Lumpur
Recruiting
Hospital Tuanku Fauziah
Kangar
Malaysia
Recruiting
Sentosa Hospital
Kuching
Malaysia
Recruiting
Sultan Abdul Halim Hospital
Sungai Petani
Malaysia
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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