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 |
|
More Details
- Status
- Recruiting
- Sponsor
- Newron Pharmaceuticals SPA