SchizophreniaPhase 3NCT03874494
Safety and Efficacy of Brexpiprazole in the Treatment of Schizophrenia
A Phase 3 study testing Brexpiprazole and Aripiprazole in people with Schizophrenia, run by Otsuka Beijing Research Institute at 1 site in China.
Trial summary
This study is a phase III, multicenter, randomized, double-blind, active-controlled, non-inferiority trial designed to assess the efficacy and safety of Brexpiprazole in the Treatment of Adults With Acute Schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Brexpiprazole and Aripiprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 371 participants
- Where
- 1 siteChina
- Study dates
- 27 Nov 2019to 6 Sep 2021
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provide written informed consent form by subjects and subject's legal guardian or legally acceptable representative.
- The subjects and subject's legal guardian or legally acceptable representative have the ability to understand the nature of the trial, agree to comply with the prescribed medication and dosage regimens, complete the scheduled visits, report the adverse events and concomitant medication to investigators, and to be reliably rated on psychiatrically scales.
- At the time of signing informed consent, 18 ≤ age of the subject ≤ 65.
- Subjects who are diagnosed with schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) and confirmed by Mini International Neuropsychiatric Interview (MINI).
- Subjects who are experiencing an acute exacerbation of psychotic symptoms and marked deterioration of usual function as demonstrated by meeting ALL of the following criteria at the screening and baseline visit:
- ● PANSS total score ≥ 70;
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- Score ≥ 4 on at least 2 of the following PANSS items :
- ( P2 Conceptual disorganization, P3 Hallucinatory behavior, P6 Suspiciousness / persecution, G9 Unusual thought content ) ● CGI-S score ≥ 4;
- Subjects willing to discontinue all prohibited psychotropic medications to meet protocol-required washouts prior to and during the trial period.
Who cannot join
- From ICF to 30 days after the last dose, females of childbearing potential and male subjects who are not willing or cannot practice contraceptive methods.
- Females who are pregnant or breastfeeding.
- Subjects who have been hospitalized for > 21 days for the current acute episode at the time of the Baseline visit, excluding hospitalization for psychosocial reasons.
- Subjects with improvement of ≥ 30% in total PANSS score between the screening and baseline assessment. Improvement in PANSS score= (score at screening-score at baseline)/ (score at screening-30)*100%.
- Subjects with schizophrenia who are considered resistant/refractory to antipsychotic treatment by history of failure to respond to 2 adequate different antipsychotic medications with a minimum of 6 weeks at clinically efficacious tolerated doses. Subjects who have a systemic treatment of clozapine.
- Subjects with a current DSM-IV-TR Axis I diagnosis (including but not limited to): schizoaffective disorder, MDD, bipolar disorder, post-traumatic stress disorder, anxiety disorders, delirium, dementia, amnestic or other cognitive disorders.
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- Subjects with a current DSM-IV-TR Axis II diagnosis: borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial personality disorders.
- Subjects who present a serious risk of suicide:
- ● Subjects who answer "Yes" on the C-SSRS Suicidal Ideation Item 4 or 5 and meeting the criteria for this C-SSRS Item 4 or 5 occurred within the last 6 months; OR
- ● Subjects who answer "Yes" on any of the 5 C-SSRS Suicidal Behavior Items and meeting the criteria for any of these 5 C-SSRS Suicidal Behavior Items occurred within the last 2 years; OR
- ● Subjects who, in the opinion of the investigator, present a serious risk of suicide
- Subjects with clinically diagnosed tardive dyskinesia, as determined by a score of ≥ 3 in Item 8 of the AIMS at the Screening visit.
- Subjects with a score of 5 in the BARS global clinical assessment of akathisia at Screening or Baseline.
- Subjects who have met DSM-IV-TR criteria for substance abuse or dependence within the 180 days prior to Screening Visit; including alcohol and benzodiazepines, but excluding caffeine and nicotine.
- Subjects with uncontrolled thyroid disease and/or abnormal free thyroxine (FT4) examination results at Screening, unless it has been confirmed by the investigator that the condition has been stabilized by medication > 90 days before screening
- Subjects with type I diabetes or uncontrolled type II diabetes. Subjects with type II diabetes may be eligible for the trial if their condition is stable as determined by satisfying ALL of the following criteria:
- HbA1c < 7.0%, AND
- Glucose must be ≤ 125 mg/dL or ≤ 6.94 mmol/L (fasting) or < 200 mg/dL or < 11.1 mmol/L (non-fasting) at Screening. If the non-fasting glucose is ≥ 200 mg/dL or ≥ 11.1 mmol/L, subjects must be retested in a fasted state and the retest value must be ≤ 125 mg/dL or ≤ 6.94 mmol/L, AND
- Subjects have maintained a stable regimen of oral anti-diabetic medication(s) for at least 28 days prior to screening or diabetes has been well-controlled by diet for at least 28 days prior to screening, AND
- Subjects have not had any hospitalizations within the 12 months prior to screening due to diabetes or complications related to diabetes, AND
- Subjects whose diabetes is not newly diagnosed during screening for the trial.
- Subjects with uncontrolled hypertension (diastolic blood pressure > 95 mmHg in any position) or symptomatic hypotension, or orthostatic hypotension which is defined as a decrease of ≥ 30 mmHg in systolic blood pressure and/or a decrease of ≥ 20 mmHg in diastolic blood pressure after at least 3 minutes standing compared to the previous supine blood pressure, OR development of symptoms.
- Subjects with a history of ischemic heart disease or history of myocardial infarction, congestive heart failure (whether controlled or uncontrolled), angioplasty, stenting, or coronary artery bypass surgery.
- Subjects who have a history or severe organic disease of vital organs (including but not limited to hepatic, renal, respiratory, cardiovascular, endocrine, neurologic, hematologic, or immunologic disease).
- Subjects with epilepsy or a history of seizures, except for a single seizure episode, for instance childhood febrile seizure and post traumatic or alcohol withdrawal.
- The following laboratory test and ECG results are exclusionary:
- 1) Platelets ≤ 75,000/mm3 (≤ 75 x 109 /L) 2) Hemoglobin ≤ 9 g/dL (90 g/L) 3) Neutrophils ≤ 1,000/mm3 (1 x 109 /L) 4) AST or ALT > 2 × ULN 5) CPK > 3 × ULN 6) Creatinine ≥ 2 mg/dL (176.8 µmol/L) 7) HbA1c ≥ 7.0% 8) QTc ≥ 450 msec (for males) or ≥ 470 msec (for females) in ECG 19. Subjects who received ECT within 60 days of screening. 20. Subjects with a history of neuroleptic malignant syndrome (NMS). 21. Subjects with a history of true allergic response (ie, not intolerance) to more than one class of medications.
- 22. Subjects who participated in a clinical trial within the last 90 days or who participated in two or more clinical trials within the past year.
- 23. Any subject who, in the opinion of the investigator, should not participate in the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase III, Multicenter, Randomized, Double-blind, Active-Controlled Study (Aripiprazole Tablets) to Evaluate the Efficacy and Safety of Brexpiprazole in the Treatment of Adults With Acute Schizophrenia
This study is a phase III, multicenter, randomized, double-blind, active-controlled, non-inferiority trial designed to assess the efficacy and safety of Brexpiprazole in the Treatment of Adults With Acute Schizophrenia. A total of approximately 370 subjects will be included in the study, and randomized to Brexpiprazole (2~4 mg/d) or Aripiprazole (10~20 mg/d) in a 1:1 ratio.
Read the detailed description
Screening Phase: It will begin when informed consent form (ICF) is signed and be a maximum of 14 days, to evaluate the inclusion/exclusion criteria, collect information such as demographic data, medical history, wash out previous antipsychotic agents and other prohibited concomitant medications.
Double-blind Treatment Phase: It lasts 6 weeks; the purpose is to compare the efficacy and safety of Brexpiprazole with Aripiprazole in the treatment of adults with acute schizophrenia.
Follow-up Phase: All subjects will be followed up for safety reasons via telephone contact or clinic visit 30 (+ 2) days after the last dose of investigational medicinal product, collecting safety information (adverse events and concomitant medication).
- Conditions
- Schizophrenia
- Being tested
- Brexpiprazole, Aripiprazole
- Keywords
- Schizophrenia, Brexpiprazole, Non-inferiority
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrexpiprazoleDrug
Also called Brexpiprazole Tablets
Brexpiprazole 2-4 mg/day
AripiprazoleDrug
Also called Aripiprazole Tablets
Aripiprazole 10-20 mg/day
| Study group | Role | What they receive |
|---|---|---|
| Brexpiprazole | Experimental | 2-4 mg/day, once daily for 6 weeks, oral administration Receives: Drug: Brexpiprazole |
| Aripiprazole | Active comparator | 10-20 mg/day, once daily for 6 weeks, oral administration Receives: Drug: Aripiprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive and Negative Syndrome Scale (PANSS) total score
The Positive and Negative Syndrome Scale (PANSS) measures psychotic symptoms in patients with schizophrenia. PANSS includes 30 items (7 items for positive symptoms, 7 items for negative symptoms, and 16 items for general psychopathology symptoms), and each item ranges from 1 to 7. The PANSS total score is a sum of scores from all items, ranging from 30 to 210, where a higher score represents severer psychotic symptoms in patients with schizophrenia.
Measured: 6 weeks
Secondary outcomes (6)
Clinical Global Impression-Severity (CGI-S) score
The Clinical Global Impression-Severity (CGI-S) score ranges from 1 to 7. A higher score represents a severer clinical impression on the patient's severity based on investigator/clinician's judgment.
Measured: 6 weeks
The Personal and Social Performance Scale (PSP) global score
The Personal and Social Performance Scale (PSP) contains four domains: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. A higher domain score represents worse functional performance in each domain. The final global score is defined according to a summary instruction table converting four domain scores into a single, overall rating from 1 to 100, where a higher score represents better personal and social function.
Measured: 6 weeks
Positive and Negative Syndrome Scale (PANSS) positive scale score
The Positive and Negative Syndrome Scale (PANSS) positive scale includes 7 items, assessing positive symptoms in schizophrenia such as delusion, hallucinatory or excitement, and each item ranges from 1 to 7. The positive scale score is a sum of scores from the 7 items, ranging from 7 to 49, where a higher score represents severer schizophrenia positive symptoms.
Measured: 6 weeks
Positive and Negative Syndrome Scale (PANSS) negative scale score
The Positive and Negative Syndrome Scale (PANSS) negative scale includes 7 items, assessing negative symptoms in schizophrenia such as blunted affect or emotional withdrawal, and each item ranges from 1 to 7. The negative scale score is a sum of scores from the 7 items, ranging from 7 to 49, where a higher score represents severer schizophrenia negative symptoms.
Measured: 6 weeks
Clinical Global Impression-Improvement (CGI-I) score
The Clinical Global Impression-Improvement (CGI-I) score ranges from 1 to 7. A higher score represents a poorer clinical impression on the patient's improvement based on investigator/clinician's judgment.
Measured: 6 weeks
Response rate
defined as reduction of ≥ 30% from baseline in PANSS Total Score OR CGI-I score of 1 [very much improved] or 2 [much improved]) at Week 6
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2019
- Study start27 Nov 2019
- Primary completion6 Aug 2021
- Study completion6 Sep 2021
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.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 371 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otsuka Beijing Research Institute
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hongyan Zhang, PhD, Principal investigator, Peking University Sixth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03874494
- Sponsor's protocol ID
- 331-403-00027
- Status last verified
- Apr 2025
- First submitted
- 12 Mar 2019
- Last updated
- 18 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multicenter, Randomized, Double-blind, Active-Controlled Study (Aripiprazole Tablets) to Evaluate the Efficacy and Safety of Brexpiprazole in the Treatment of Adults With Acute Schizophrenia
- ClinicalTrials.gov ID
- NCT03874494
- Acronym / sponsor ID
- 331-403-00027
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Brexpiprazole, Non-inferiority
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 371 participants (actual)
- Lead sponsor
- Otsuka Beijing Research InstituteIndustry (pharma, biotech, devices)
- Study start
- 27 Nov 2019 (actual)
- Primary completion
- 6 Aug 2021 (actual)
- Study completion
- 6 Sep 2021 (actual)
- First posted
- 14 Mar 2019 (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.
This study is a phase III, multicenter, randomized, double-blind, active-controlled, non-inferiority trial designed to assess the efficacy and safety of Brexpiprazole in the Treatment of Adults With Acute Schizophrenia. A total of approximately 370 subjects will be included in the study, and randomized to Brexpiprazole (2~4 mg/d) or Aripiprazole (10~20 mg/d) in a 1:1 ratio.
Detailed description
Screening Phase: It will begin when informed consent form (ICF) is signed and be a maximum of 14 days, to evaluate the inclusion/exclusion criteria, collect information such as demographic data, medical history, wash out previous antipsychotic agents and other prohibited concomitant medications.
Double-blind Treatment Phase: It lasts 6 weeks; the purpose is to compare the efficacy and safety of Brexpiprazole with Aripiprazole in the treatment of adults with acute schizophrenia.
Follow-up Phase: All subjects will be followed up for safety reasons via telephone contact or clinic visit 30 (+ 2) days after the last dose of investigational medicinal product, collecting safety information (adverse events and concomitant medication).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brexpiprazole | Experimental | Drug: Brexpiprazole2-4 mg/day, once daily for 6 weeks, oral administration |
| Aripiprazole | Active comparator | Drug: Aripiprazole10-20 mg/day, once daily for 6 weeks, oral administration |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Provide written informed consent form by subjects and subject's legal guardian or legally acceptable representative.
- The subjects and subject's legal guardian or legally acceptable representative have the ability to understand the nature of the trial, agree to comply with the prescribed medication and dosage regimens, complete the scheduled visits, report the adverse events and concomitant medication to investigators, and to be reliably rated on psychiatrically scales.
- At the time of signing informed consent, 18 ≤ age of the subject ≤ 65.
- Subjects who are diagnosed with schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) and confirmed by Mini International Neuropsychiatric Interview (MINI).
- Subjects who are experiencing an acute exacerbation of psychotic symptoms and marked deterioration of usual function as demonstrated by meeting ALL of the following criteria at the screening and baseline visit:
Key exclusion criteria (29 listed)
- From ICF to 30 days after the last dose, females of childbearing potential and male subjects who are not willing or cannot practice contraceptive methods.
- Females who are pregnant or breastfeeding.
- Subjects who have been hospitalized for > 21 days for the current acute episode at the time of the Baseline visit, excluding hospitalization for psychosocial reasons.
- Subjects with improvement of ≥ 30% in total PANSS score between the screening and baseline assessment. Improvement in PANSS score= (score at screening-score at baseline)/ (score at screening-30)*100%.
- Subjects with schizophrenia who are considered resistant/refractory to antipsychotic treatment by history of failure to respond to 2 adequate different antipsychotic medications with a minimum of 6 weeks at clinically efficacious tolerated doses. Subjects who have a systemic treatment of clozapine.
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 |
|---|---|---|
| BrexpiprazoleAlso: Brexpiprazole TabletsBrexpiprazole 2-4 mg/day | Drug | Brexpiprazole |
| AripiprazoleAlso: Aripiprazole TabletsAripiprazole 10-20 mg/day | Drug | Aripiprazole |
Primary outcome
Positive and Negative Syndrome Scale (PANSS) total score
Time frame: 6 weeks
The Positive and Negative Syndrome Scale (PANSS) measures psychotic symptoms in patients with schizophrenia. PANSS includes 30 items (7 items for positive symptoms, 7 items for negative symptoms, and 16 items for general psychopathology symptoms), and each item ranges from 1 to 7. The PANSS total score is a sum of scores from all items, ranging from 30 to 210, where a higher score represents severer psychotic symptoms in patients with schizophrenia.
6 secondary outcomes
Clinical Global Impression-Severity (CGI-S) score
Time frame: 6 weeks
The Personal and Social Performance Scale (PSP) global score
Time frame: 6 weeks
Positive and Negative Syndrome Scale (PANSS) positive scale score
Time frame: 6 weeks
Positive and Negative Syndrome Scale (PANSS) negative scale score
Time frame: 6 weeks
Clinical Global Impression-Improvement (CGI-I) score
Time frame: 6 weeks
Response rate
Time frame: 6 weeks
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 18 Apr 2025.
- Individual participant dataSharing planned: No
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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.
Hongyan Zhang, PhD principal investigator
Peking University Sixth Hospital
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 Brexpiprazole and Aripiprazole in people with Schizophrenia, run by Otsuka Beijing Research Institute at 1 site in China.
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 9 inclusion and 29 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 18 Apr 2025. 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 China. 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?
Positive and Negative Syndrome Scale (PANSS) total score (time frame: 6 weeks). 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 18 Apr 2025.