Evenamide, a Glutamate Release Modulator, as Add-On to Standard of Care in Subjects With Documented Treatment-Resistant Schizophrenia
- Conditions
- Treatment-resistant Schizophrenia
- Interventions
- Drug: Evenamide 15 mg bidDrug: Placebo
- Registration Number
- NCT07184619
- Lead Sponsor
- Newron Pharmaceuticals SPA
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 400
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Evenamide 15 mg bid Evenamide 15 mg bid Evenamide capsules 15 mg bid for a total of 12 weeks of add-on treatment Placebo Placebo Matching placebo capsules bid for a total of 12 weeks of add-on treatment
- Primary Outcome Measures
Name Time Method 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).
- Secondary Outcome Measures
Name Time Method Change from baseline to endpoint (Week 12) on the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form scale (Q-LES-Q-SF). From Baseline to Week 12 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).
Proportion of patients rated as 'improved' on the CGI-C at endpoint (Week 12). 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'.
Change from baseline to endpoint (Week 12) on the Clinical Global Impression - Severity of illness (CGI-S) score. From Baseline to Week 12 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.
Change from baseline to endpoint (Week 12) on the Personal and Social Performance (PSP) scale. From Baseline to Week 12 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.
Change from baseline to endpoint (Week 12) on the Positive Symptoms sub-scale score of the PANSS. From Baseline to Week 12 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).
Trial Locations
- Locations (5)
UCLA DGSOM, UCLA Health, UCLA Semel Institute
🇺🇸Los Angeles, California, United States
University of Miami, Miller School of Medicine; Jackson Behavioral Health Hospital
🇺🇸Miami, Florida, United States
Grady Behavioral Health Center, -Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine
🇺🇸Atlanta, Georgia, United States
Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine
🇺🇸Baltimore, Maryland, United States
Manhattan Psychiatric Center, The Nathan Kline Institute for Psychiatric Research
🇺🇸New York, New York, United States
UCLA DGSOM, UCLA Health, UCLA Semel Institute🇺🇸Los Angeles, California, United StatesSite contactContact310-478-3711GDeVera@mednet.ucla.edu