Evenamide, a Glutamate Release Modulator, as Add-On to Standard of Care in Subjects With Documented Treatment-Resistant Schizophrenia
A Phase III, 12-week, Prospective, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center Study to Determine the Efficacy, Safety, and Tolerability of a Dose of 15 mg Bid of Evenamide as add-on in Patients With Documented Treatment-resistant Schizophrenia, Which is Not Adequately Controlled by a Stable Therapeutic Dose of the Patient's Current Antipsychotic Medication(s)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This 12-week study tests evenamide, taken as 15 mg twice a day, added to usual treatment for schizophrenia. It is for adults whose symptoms have not improved enough with antipsychotic medicines. The study compares evenamide with a placebo (a pill with no study drug) to see how well it works and how safe it is.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be 18 or older.
- Have schizophrenia that has not improved enough with antipsychotic medicines, based on the study’s rules.
- Take one or more antipsychotic medicines at the minimum recommended treatment dose or higher, and take them as prescribed.
- Have a study rating of illness from “mildly ill” to “among the most extremely ill” at the start.
- Meet symptom score limits: BPRS of at least 45 at screening and the start, and PANSS of at least 70 at the start.
- Have a GAF score of 50 or less, which measures how well you manage daily life.
- If female, have negative pregnancy tests at screening and the start, not breastfeed, and agree to birth control unless unable to become pregnant.
- Give written consent before joining the study.
Who can't join
- Have another main mental health diagnosis, such as schizoaffective disorder, schizophreniform disorder, bipolar disorder, or major depression.
- Have a substance use disorder now or within the past 3 months.
- Need hospital care for severe psychosis, which can affect your sense of reality. You may still qualify if your antipsychotic dose has been stable for 6 weeks before screening.
- Have other mental health or behavior disorders now or in the past.
- Have a known suicide risk or have attempted suicide in the past 2 years.
- Have had neuroleptic malignant syndrome (a severe reaction to antipsychotic drugs) or priapism (a long-lasting erection).
- Have a health condition that could make the study unsafe for you or affect study tests.
- Have epilepsy or a seizure disorder now or in the past, a seizure in the past year, or repeated seizures caused by drugs.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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.
Study sites (5)
CA
- UCLA DGSOM, UCLA Health, UCLA Semel Institute · Los Angeles, CA 90095More trials in Los Angeles
FL
- University of Miami, Miller School of Medicine; Jackson Behavioral Health Hospital · Miami, FL 33136More trials in Miami
GA
- Grady Behavioral Health Center, -Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine · Atlanta, GA 30322More trials in Atlanta
MD
- Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine · Baltimore, MD 21224More trials in Baltimore
NY
- Manhattan Psychiatric Center, The Nathan Kline Institute for Psychiatric Research · New York, NY 10035More trials in New York