Safety and Efficacy of Brexpiprazole in the Treatment of Schizophrenia

NCT03874494 | Completed Phase 3

• 1 other identifier: 331-403-00027
• Study Type: interventional
• Target: 371
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Schizophrenia

Keywords

Schizophrenia; Brexpiprazole; Non-inferiority

Outcome Measures

Primary Outcomes (1)

• 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.

  6 weeks

Secondary Outcomes (6)

• Clinical Global Impression-Severity (CGI-S) score

  6 weeks

• The Personal and Social Performance Scale (PSP) global score

  6 weeks

• Positive and Negative Syndrome Scale (PANSS) positive scale score

  6 weeks

• Positive and Negative Syndrome Scale (PANSS) negative scale score

  6 weeks

• Clinical Global Impression-Improvement (CGI-I) score

  6 weeks

Study Arms (2)

Brexpiprazole

EXPERIMENTAL

2-4 mg/day, once daily for 6 weeks, oral administration

Drug: Brexpiprazole

Aripiprazole

ACTIVE COMPARATOR

10-20 mg/day, once daily for 6 weeks, oral administration

Drug: Aripiprazole

Interventions

Brexpiprazole DRUG

Brexpiprazole 2-4 mg/day

Also known as: Brexpiprazole Tablets

Brexpiprazole

Aripiprazole DRUG

Aripiprazole 10-20 mg/day

Also known as: Aripiprazole Tablets

Aripiprazole

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Otsuka Beijing Research Institute: lead

Study Sites (1)

No.15 Yanyin Road, Yanta District

Xi’an, Shanxi, 710061, China

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

brexpiprazole; Aripiprazole

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Hongyan Zhang, PhD

  Peking University Sixth Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2019
• First Posted: March 14, 2019
• Study Start: November 27, 2019
• Primary Completion: August 6, 2021
• Study Completion: September 6, 2021
• Last Updated: April 18, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)