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New treatment option for Treatment-resistant Schizophrenia
Official title Evenamide, a Glutamate Release Modulator, as Add-On to Standard of Care in Subjects With Documented Treatment-Resistant Schizophrenia
ClinicalTrials.gov ID: NCT07184619
What this study is testing
What is Evenamide 15 mg bid?
Evenamide 15 mg bid is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for treatment-resistant schizophrenia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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).
You likely can't join if
- Current DSM-5-TR diagnosis of schizophreniform disorder, schizoaffective disorder, or other primary psychiatric diagnosis, such as bipolar 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...
- 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.
See the full eligibility 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
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Miami, Florida, United States
- Atlanta, Georgia, United States
- Baltimore, Maryland, United States
- New York, New York, United States
- Vijayawada, Andhra Pradesh, India
- Mumbai, Maharashtra, India
- Madurai, Tamil Nadu, India
- Lucknow, Uttar Pradesh, India
- Kolkata, West Bengal, India
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Miami, Florida, United States; Atlanta, Georgia, United States; Baltimore, Maryland, United States; New York, New York, United States; Vijayawada, Andhra Pradesh, India and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.