SchizophreniaPhase 3NCT05326347
A Long-term Administration Trial of Brexpiprazole Once-weekly (QW) Formulation in Patients With Schizophrenia
A Phase 3 study testing OPC-34712FUM/ Brexpiprazole fumarate in people with Schizophrenia, run by Otsuka Pharmaceutical Co., Ltd. at 1 site in Japan.
Trial summary
Confirm the tolerability and safety of long-term administration of the brexpiprazole QW formulation in patients with schizophrenia Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- OPC-34712FUM/ Brexpiprazole fumarate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 247 participants
- Where
- 1 siteJapan
- Study dates
- 31 May 2022to 30 Sep 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- New Subjects
- 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
- 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® at the time of informed consent
- Patients who are receiving treatment with antipsychotics (other than clozapine), who are considered to require maintenance therapy using antipsychotics, and for whom monotherapy with the brexpiprazole QW formulation and outpatient management are considered feasible. Hospitalization for washout from any previously used drugs specified as prohibited concomitant drugs or hospitalization for symptom management immediately after the start of IMP administration will be allowed at the discretion of the investigator. Hospitalization for social reasons (eg, homelessness or need for shelter that is unrelated to the patient's psychological condition) is permitted.
- Period 1:
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- Patients for whom switching to monotherapy with the brexpiprazole QW formulation using an add-on and taper-off method within 4 weeks is considered feasible
- Period 2:
- Patients who are able to begin monotherapy with the brexpiprazole QW formulation (at an initial dose of 48 mg/week) Rollover Subjects
- 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
- Patients who have completed the 6-week double-blind treatment period in Trial 331-102-00062
- Patients for whom monotherapy with the brexpiprazole QW formulation and outpatient management are considered feasible. Hospitalization for symptom management immediately after the start of IMP administration will be allowed at the discretion of the investigator. Hospitalization for social reasons (eg, homelessness or need for shelter that is unrelated to the patient's psychological condition) is permitted.
Who cannot join
- New Subjects
- Patients who are considered resistant/refractory to antipsychotic treatment Patients who are
- 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 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 Columbia-Suicide Severity Rating Scale (C-SSRS) suicidal ideation at screening (for the past 6 months) or at baseline (since the last assessment)
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- 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 Abnormal Involuntary Movement Scale (AIMS) at screening or at baseline
- Patients with a score of 5 (severe akathisia) in the Barnes Akathisia Rating Scale (BARS) global clinical assessment of akathisia at screening or at baseline
- 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 disorder
- 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 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 c+E97onsidered 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 judged by the investigator to be unsuitable for participation in the trial Rollover Subjects
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Uncontrolled, Open-label Trial to Investigate the Long-term Tolerability, Safety, and Efficacy of Brexpiprazole Once-weekly (QW) Formulation Administered Once Weekly for 52 Weeks in Patients With Schizophrenia
Confirm the tolerability and safety of long-term administration of the brexpiprazole QW formulation in patients with schizophrenia
- Conditions
- Schizophrenia
- Being tested
- OPC-34712FUM/ Brexpiprazole fumarate
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPC-34712FUM/ Brexpiprazole fumarateDrug
The treatment will begin with oral administration of 1 tablet of the brexpiprazole QW formulation.
| Study group | Role | What they receive |
|---|---|---|
| Rollover subjects | Experimental | For rollover subjects, treatment will begin with oral administration of 1 tablet of the brexpiprazole QW formulation at 24 mg. From Week 1 onward, 2 tablets of brexpiprazole QW formulation 24 mg (48 mg/week) will be orally administered for 51 weeks. Receives: Drug: OPC-34712FUM/ Brexpiprazole fumarate |
| New subjects | Experimental | In medication switching period, treatment will begin with oral administration of 1 tablet of the brexpiprazole QW formulation 24 mg, and the dose of the other antipsychotics will be gradually reduced, finally switching to monotherapy with 2 tablets of brexpiprazole QW formulation 24 mg (48 mg/week) by Week 4. In treatment period, 2 tablets of brexpiprazole QW formulation 24 mg (48 mg/week) will be orally administered for 52 weeks. Receives: Drug: OPC-34712FUM/ Brexpiprazole fumarate |
What is being measured
The primary outcome is the main question the study is designed to answer.
The frequency of Adverse Events
Measured: From baseline to week 52
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 start31 May 2022
- Primary completion26 Aug 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 247 participants (actual)
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
- NCT05326347
- Sponsor's protocol ID
- 331-102-00063
- Status last verified
- Sep 2026
- First submitted
- 6 Apr 2022
- Last updated
- 11 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 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Uncontrolled, Open-label Trial to Investigate the Long-term Tolerability, Safety, and Efficacy of Brexpiprazole Once-weekly (QW) Formulation Administered Once Weekly for 52 Weeks in Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT05326347
- Acronym / sponsor ID
- 331-102-00063
- Conditions
- Schizophrenia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 247 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 May 2022 (actual)
- Primary completion
- 26 Aug 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- 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 tolerability and safety of long-term administration of the brexpiprazole QW formulation in patients with schizophrenia
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rollover subjects | Experimental | Drug: OPC-34712FUM/ Brexpiprazole fumarateFor rollover subjects, treatment will begin with oral administration of 1 tablet of the brexpiprazole QW formulation at 24 mg. From Week 1 onward, 2 tablets of brexpiprazole QW formulation 24 mg (48 mg/week) will be orally administered for 51 weeks. |
| New subjects | Experimental | Drug: OPC-34712FUM/ Brexpiprazole fumarateIn medication switching period, treatment will begin with oral administration of 1 tablet of the brexpiprazole QW formulation 24 mg, and the dose of the other antipsychotics will be gradually reduced, finally switching to monotherapy with 2 tablets of brexpiprazole QW formulation 24 mg (48 mg/week) by Week 4. In treatment period, 2 tablets of brexpiprazole QW formulation 24 mg (48 mg/week) will be orally administered for 52 weeks. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- New Subjects
- 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
- 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® at the time of informed consent
- Patients who are receiving treatment with antipsychotics (other than clozapine), who are considered to require maintenance therapy using antipsychotics, and for whom monotherapy with the brexpiprazole QW formulation and outpatient management are considered feasible. Hospitalization for washout from any previously used drugs specified as prohibited concomitant drugs or hospitalization for symptom management immediately after the start of IMP administration will be allowed at the discretion of the investigator. Hospitalization for social reasons (eg, homelessness or need for shelter that is unrelated to the patient's psychological condition) is permitted.
Key exclusion criteria (17 listed)
- New Subjects
- Patients who are considered resistant/refractory to antipsychotic treatment Patients who are
- 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 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
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 fumarateThe treatment will begin with oral administration of 1 tablet of the brexpiprazole QW formulation. | Drug | New subjects, Rollover subjects |
Primary outcome
The frequency of Adverse Events
Time frame: From baseline to week 52
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 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. This study is not recruiting at the moment.
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 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 12 inclusion and 17 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: finished, as of the sponsor's last update on 11 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The frequency of Adverse Events (time frame: From baseline to week 52). 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 11 Sep 2026.