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
Overview
- Phase
- Phase 3
- Intervention
- Brexpiprazole
- Conditions
- Schizophrenia
- Sponsor
- Otsuka Beijing Research Institute
- Enrollment
- 371
- Locations
- 1
- Primary Endpoint
- Positive and Negative Syndrome Scale (PANSS) total score
- Status
- Completed
- Last Updated
- last year
Overview
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.
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 ≤
- •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.
Exclusion Criteria
- •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
Arms & Interventions
Brexpiprazole
2-4 mg/day, once daily for 6 weeks, oral administration
Intervention: Brexpiprazole
Aripiprazole
10-20 mg/day, once daily for 6 weeks, oral administration
Intervention: Aripiprazole
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Clinical Global Impression-Severity (CGI-S) score(6 weeks)
- Positive and Negative Syndrome Scale (PANSS) negative scale score(6 weeks)
- Response rate(6 weeks)
- Positive and Negative Syndrome Scale (PANSS) positive scale score(6 weeks)
- The Personal and Social Performance Scale (PSP) global score(6 weeks)
- Clinical Global Impression-Improvement (CGI-I) score(6 weeks)