Acute SchizophreniaPhase 3NCT05325645
Trial of Brexpiprazole Once-weekly (QW) Formulation in Patients With Acute Schizophrenia
A Phase 3 study testing OPC-34712FUM/ Brexpiprazole fumarate in people with Acute Schizophrenia, run by Otsuka Pharmaceutical Co., Ltd. at 1 site in Japan.
Trial summary
Confirm the efficacy of the brexpiprazole QW formulation versus placebo for acute symptoms of schizophrenia Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Acute Schizophrenia
- What is being tested?
- OPC-34712FUM/ Brexpiprazole fumarate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 450 participants
- Where
- 1 siteJapan
- Study dates
- 21 Jul 2022to Oct 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- <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
Show all 23Show fewer
- 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
- Received 2 or more antipsychotics, each at doses equivalent to ≥ 600 mg/day of chlorpromazine
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Drug Information Center contact
About this study
Official title: A Multicenter, Placebo-controlled, Randomized, Double-blind, Parallel-group Comparison Trial to Investigate the Efficacy and Safety of Brexpiprazole Once-weekly (QW) Formulation in Patients With Acute Schizophrenia
Confirm the efficacy of the brexpiprazole QW formulation versus placebo for acute symptoms of schizophrenia
- Conditions
- Acute Schizophrenia
- Being tested
- OPC-34712FUM/ Brexpiprazole fumarate, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPC-34712FUM/ Brexpiprazole fumarateDrug
2 brexpiprazole QW tablets 24 mg (48 mg/dose) will be orally administered once weekly for 7weeks.(As an initial dose, one brexpiprazole QW tablet 24 mg and one placebo tablet will be orally administered (24 mg/dose))
PlaceboDrug
Two placebo tablets will be orally administered once weekly for 7weeks.
| Study group | Role | What they receive |
|---|---|---|
| Brexpiprazole QW 48mg | Experimental | Brexpiprazole QW 48mg, tablet, once weekly, for seven weeks(Initial dose Brexpiprazole QW 24mg) Receives: Drug: OPC-34712FUM/ Brexpiprazole fumarate |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score at last visit of the double-blind period
Measured: Baseline and Week 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2022
- Study start21 Jul 2022
- Primary completionSep 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute SchizophreniaStudies of the same condition, open and under way.
- More trials run by Otsuka Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Takeshi Tsunoda, Study director, Otsuka Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05325645
- Sponsor's protocol ID
- 331-102-00062
- Status last verified
- Sep 2026
- First submitted
- 6 Apr 2022
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal.
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Placebo-controlled, Randomized, Double-blind, Parallel-group Comparison Trial to Investigate the Efficacy and Safety of Brexpiprazole Once-weekly (QW) Formulation in Patients With Acute Schizophrenia
- ClinicalTrials.gov ID
- NCT05325645
- Acronym / sponsor ID
- 331-102-00062
- Conditions
- Acute Schizophrenia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Study start
- 21 Jul 2022 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 13 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Confirm the efficacy of the brexpiprazole QW formulation versus placebo for acute symptoms of schizophrenia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brexpiprazole QW 48mg | Experimental | Drug: OPC-34712FUM/ Brexpiprazole fumarateBrexpiprazole QW 48mg, tablet, once weekly, for seven weeks(Initial dose Brexpiprazole QW 24mg) |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (23 listed)
- <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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OPC-34712FUM/ Brexpiprazole fumarate2 brexpiprazole QW tablets 24 mg (48 mg/dose) will be orally administered once weekly for 7weeks.(As an initial dose, one brexpiprazole QW tablet 24 mg and one placebo tablet will be orally administered (24 mg/dose)) | Drug | Brexpiprazole QW 48mg |
| PlaceboTwo placebo tablets will be orally administered once weekly for 7weeks. | Drug | Placebo |
Primary outcome
Mean change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score at last visit of the double-blind period
Time frame: Baseline and Week 7
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: Yes. Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Drug Information Center contact
Takeshi Tsunoda study director
Otsuka Pharmaceutical Co., Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing OPC-34712FUM/ Brexpiprazole fumarate in people with Acute Schizophrenia, run by Otsuka Pharmaceutical Co., Ltd. at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Drug Information Center (+81-3-6361-7314), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score at last visit of the double-blind period (time frame: Baseline and Week 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.