RecruitingPhase 3

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

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