Phase 3 Schizophrenia Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who are at least 18 years old and under 65 years old at the time of signing the consent form
• People who have been diagnosed with schizophrenia (specifically, multiple episodes and currently in an acute episode) based on a recognised diagnostic standard, confirmed by a structured interview at the time of consent
• People who are currently in hospital, or whose doctor has determined they need to be hospitalised, due to an acute relapse of schizophrenia
• People whose current episode began within 2 months before the screening visit
• People who were previously treated with antipsychotic medications (not including clozapine) at appropriate doses and were found to respond to that treatment
• People whose symptoms returned or worsened during a period when they were not taking antipsychotic medication
• People who have been fully informed about the trial and are able to provide written consent before any trial procedures begin

Who may not be able to join:

• People experiencing their very first episode of schizophrenia, as determined by the treating doctor
• People whose schizophrenia has not responded to two or more antipsychotic medications taken at effective doses for at least 6 weeks each (considered treatment-resistant)
• People who have previously been treated with clozapine for schizophrenia
• People experiencing significant depressive symptoms in the 30 days before consent that, in the doctor's opinion, require antidepressant treatment
• People who, in the 6 months before screening or since their last assessment, have reported serious thoughts of suicide with some intention or a specific plan, based on a standard assessment tool
• People who have shown suicidal behaviour in the 2 years before screening or since their last assessment, based on a standard assessment tool, or who the doctor considers to be at serious risk of suicide
• People with moderate or severe involuntary movements (tardive dyskinesia), as measured by a standard rating scale at screening or at the start of the trial
• People with severe restlessness (akathisia), as measured by a standard rating scale at screening or at the start of the trial
• People who, in the 30 days before screening, were taking two or more antipsychotic medications each at high doses, or were taking antipsychotics at a combined daily dose above a specified high threshold (confirm with trial site for exact dose details)
• People who have a diagnosis of another mental health condition alongside schizophrenia — such as schizoaffective disorder, major depression, bipolar disorder, anxiety disorder, OCD, PTSD, dementia, or personality disorder — though caffeine- or tobacco-related conditions are not excluded on this basis
• People who have met the diagnostic criteria for a substance use or addictive disorder (including alcohol or benzodiazepines, but not caffeine or tobacco) within the 180 days before the trial medication is due to start
• People with a significant medical condition affecting the nervous system, liver, kidneys, metabolism, blood, immune system, heart, lungs, or digestive system (minor or well-controlled conditions may be assessed individually by the trial site)
• People with a known allergy or intolerance to the study drug brexpiprazole, a confirmed lack of response to brexpiprazole, or who have already received brexpiprazole during their current episode
• People the treating doctor considers unsuitable for the trial for any other reason

Important: Always verify eligibility with the trial site directly before applying.