Can a Once-a-Week antipsychotic tablet calm acute schizophrenia?
NCT ID NCT05325645
First seen Sep 16, 2026 · Last updated Sep 17, 2026 · Updated 1 time
Summary
Researchers are testing a once-weekly tablet of brexpiprazole against placebo in adults hospitalized for an acute episode of schizophrenia. The trial enrolls about 450 people aged 18 to 74 who need hospital care for a relapse. Over seven weeks, participants receive either the active tablet or a placebo, and researchers measure changes in symptom scores to see if the weekly formulation helps.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- brexpiprazole, an antipsychotic drug given as a once-weekly tablet
- What this could lead to
- If it works, a once-weekly tablet could offer a simpler dosing option for people managing acute schizophrenia symptoms.
- What could go wrong
- The trial may show the weekly tablet works no better than placebo, or it may cause side effects that limit its use. Results in hospitalized adults may not apply to everyone with schizophrenia.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 450 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2022
- Expected to finish
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Oct 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 74 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients at least 18 years of age and below the age of 75 at the time of informed consent * Patients with a diagnosis of schizophrenia based on DSM-5® (295.90) (multiple episodes, currently in acute episode) and confirmed by the Mini International Neuropsychiatric Interview (M.I.N.I.) at the time of informed consent * Patients who are hospitalized, or judged to require hospitalization, for acute relapse of schizophrenia at the time of informed consent * Patients whose current episode developed within 2 months prior to screening * Patients who were treated with antipsychotics at appropriate doses for appropriate durations for the most recent acute episode and who are considered to have responded to the antipsychotics (excluding clozapine) * Patients who experienced a recurrence or exacerbation of symptoms during an antipsychotic-free period * Patients who have been fully informed of and understand the objectives, procedures, risks, and expected medicinal benefits of the trial and are able to provide written informed consent prior to initiation of any trial-related procedures Exclusion Criteria: \<Regarding indication\> * Patients presenting a first episode of schizophrenia based on the clinical judgment of the investigator * Patients who are considered resistant/refractory to antipsychotic treatment Patients who are "unresponsive to medication with 2 or more antipsychotics at effective doses for a sufficiently long duration (6 weeks)" will be deemed resistant/refractory to antipsychotic treatment. * Patients who have a history of treatment with clozapine for schizophrenia * Patients experiencing acute depressive symptoms within 30 days prior to informed consent that, in the judgment of the investigator, require treatment with an antidepressant * Patients who fall under any of the following criteria regarding suicidal ideation and suicidal behavior * Patients who answered "yes" to Question 4 "Active Suicidal Ideation with Some Intent to Act, without Specific Plan" or Question 5 "Active Suicidal Ideation with Specific Plan and Intent" regarding C-SSRS suicidal ideation at screening (for the past 6 months) or at baseline (since the last assessment) * Patients who exhibited suicidal behavior on C-SSRS at screening (for the past 2 years) or at baseline (since the last assessment) * Patients who present a serious risk of suicide based on the judgment of the investigator * Patients presenting tardive dyskinesia at the time of informed consent, as determined by a score of 3 (moderate) or 4 (severe) for Item 8 (severity of abnormal movements) of the AIMS at screening or at baseline * Patients with a score of 5 (severe akathisia) in the BARS global clinical assessment of akathisia at screening or at baseline * Patients who meet either of the following criteria between 30 days before screening and the start of screening\* * Not including the start date of screening 1. Received 2 or more antipsychotics, each at doses equivalent to ≥ 600 mg/day of chlorpromazine 2. Received a mean daily dose equivalent to \> 800 mg/day\*\*,\*\*\* of chlorpromazine '\*\*If multiple antipsychotics are taken in the same day, this is to be the combined equivalent dose. \*\*\*This does not include administration of antipsychotic medication at doses equivalent to less than 100 mg/day of chlorpromazine, which are not expected to have any antipsychotic effect. Chlorpromazine equivalent doses are based on Equivalent Conversion Table for Antipsychotics, as specified separately. * Patients with a diagnosis of a concurrent mental disorder besides schizophrenia (schizoaffective disorder, major depressive disorder, bipolar I disorder, bipolar II disorder, general anxiety disorder, obsessive-compulsive disorder, post-traumatic stress disorder, dementia or mild neurocognitive disorder, personality disorder, etc) based on DSM-5®. However, this exclusion does not apply to the following: • Caffeine- or tobacco-related disorders * Patients who have met the DSM-5® diagnostic criteria for substance-related or addictive disorder, including alcohol and benzodiazepines but excluding caffeine and tobacco, within 180 days before commencement of investigational medicinal product (IMP) administration * Patients who have a clinically significant neurological, hepatic, renal, metabolic, hematological, immunological, cardiovascular, pulmonary, or gastrointestinal disorder. Medical conditions that are minor or well-controlled may be considered acceptable if the condition does not interfere with safety and efficacy assessments. * Patients with known hypersensitivity or intolerance to brexpiprazole or patients with confirmed resistance to brexpiprazole therapy. Patients who have received brexpiprazole to treat the current episode. * Patients judged by the investigator to be unsuitable for participation in the trial.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Hayakawa Clinic
RECRUITINGKure-shi, Japan