Safety and Efficacy of Brexpiprazole in the Treatment of Schizophrenia (NCT03874494) | Clinical Trial Compass
CompletedPhase 3
Safety and Efficacy of Brexpiprazole in the Treatment of Schizophrenia
China371 participantsStarted 2019-11-27
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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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 ≤ 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:
✓. 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.
What they're measuring
1
Positive and Negative Syndrome Scale (PANSS) total score
✕. 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: