Evenamide, a Glutamate Release Modulator, as Add-On to Standard of Care in Subjects With Documented Treatment-Resistant Schizophrenia
Purpose
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.
Condition
- Treatment-resistant Schizophrenia
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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.
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.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Evenamide 15 mg bid |
Evenamide capsules 15 mg bid for a total of 12 weeks of add-on treatment |
|
|
Placebo Comparator Placebo |
Matching placebo capsules bid for a total of 12 weeks of add-on treatment |
|
Recruiting Locations
UCLA DGSOM, UCLA Health, UCLA Semel Institute
Los Angeles, California 90095
Los Angeles, California 90095
Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine
Baltimore, Maryland 21224
Baltimore, Maryland 21224
Manhattan Psychiatric Center, The Nathan Kline Institute for Psychiatric Research
New York, New York 10035
New York, New York 10035
More Details
- Status
- Recruiting
- Sponsor
- Newron Pharmaceuticals SPA