Schizophrenia MedDRA version: 20.0 Level: LLT Classification code 10039636 Term: Schizophrenia simple System Organ Class: 100000004873
Conditions
Sponsors
Otsuka Pharmaceutical Development & Commercialization, Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria for Rollover Subjects from Trial 331 10 234 1. Written informed consent/assent obtained from a legally acceptable representative (eg, guardian) or subject prior to the initiation of any protocol-required procedures. The subject must provide informed assent and must be able to understand that he or she can withdraw from the trial at any time. 2. Ability, in the opinion of the principal investigator, of the subject and the subject’s legally acceptable representative (eg, guardian) or caregiver(s) to understand the nature of the trial and follow protocol requirements, including the prescribed dosage regimens. 3. Male and female subjects 13 to 18 years of age, inclusive, at the time of informed consent/assent and at baseline. Subjects who turned 18 years old during Trial 331-10-234 are permitted in this trial. 4. Subjects who complete Trial 331-10-234 and who, in the opinion of the investigator, could potentially benefit from monotherapy treatment with oral brexpiprazole for schizophrenia. The baseline visit for Trial 331-10-236 coincides with the Week 6 visit of Trial 331-10-234. If the visit cannot be done within = 7 days of the Week 6 visit of Trial 331-10-234 then the subject may be able to enter Trial 331-10-236 as a de novo subject following approval by the medical monitor. 5. Outpatient status at the last visit of Trial 331-10-234. Hospitalization for psychosocial reasons (eg, homelessness or need for shelter that is unrelated to the subject’s underlying psychiatric condition) will be considered outpatient status for the purpose of enrollment in Trial 331-10-236. Subjects remaining in hospital at the Week 6 visit of Trial 331-10-234 (for other than psychosocial reasons) will be permitted to enroll in Trial 331-10-236 at the Week 6 visit of the double-blind trial if they are planned to be discharged from the hospital before the open-label treatment period Week 1 visit of Trial 331-10-236 and following by the medical monitor. Inclusion Criteria for De Novo Subjects 1. Written informed consent obtained from a legally acceptable representative (eg, guardian) prior to the initiation of any protocol-required procedures. The subject must provide informed assent and and must be able to understand that he or she can withdraw from the trial at any time. 2. Ability, in the opinion of the principal investigator, of the subject and the subject’s legally acceptable representative (eg, guardian) or caregiver(s) to understand the nature of the trial and follow protocol requirements. 3. Male and female subjects 13 to 17 years of age, inclusive, at the time of informed consent/assent and at the baseline (Day 1) visit of the open-label treatment period. Subjects who turned 18 years of age since participation in Trial 331-10-234, if applicable, are permitted to enroll in this trial. 4. Subjects with a current primary diagnosis of schizophrenia, as defined by DSM-5 criteria and a history of the illness (diagnosis or symptoms) for at least 6 months prior to screening (as per subject, family, or healthcare provider, or by previous medical records). For subjects who did not participate in Trial 331-10-234, the initial diagnosis of schizophrenia for this trial should(as defined by DSM-5 criteria) must be documented by an adequately trained clinician, and the diagnosis should then be confirmed utilizing the K SADS-PL performed by an adequately trained rater at the time of entry into Trial 331-10-236. (Subjects with a diagnosis of
Exclusion criteria
Exclusion criteria: Key exclusion criteria include the following: • Subjects with a DSM-5 diagnosis other than schizophrenia that has been the primary focus of treatment within 3 months of screening. • Subjects with a clinical presentation or history that is consistent with delirium, dementia, amnesia, or other cognitive disorders; subjects with psychotic symptoms that are better accounted for by another general medical condition(s) or direct effect of a substance (eg, medication, illicit drug use). • Any neurological disorder, with the exception of Tourette’s syndrome. • Subjects experiencing acute depressive symptoms within the past 30 days prior to screening that, according to the investigator’s judgment, require treatment with an antidepressant. • Subjects with schizophrenia who are considered treatment resistant to antipsychotic medication, including aripiprazole or brexpiprazole, at an adequate dose and duration as confirmed by medical history, investigator judgment, or subject report. Subjects with a history of relapse due to lack of medication compliance or drug abuse can be considered based on investigator judgment. • Subjects with a history of failure of clozapine treatment or response to clozapine treatment only.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of the trial is to characterize the long-term safety and tolerability of brexpiprazole in adolescents with schizophrenia.;Secondary Objective: Not applicable;Primary end point(s): The primary endpoints of this trial are the frequency and severity of AEs, serious treatment-emergent adverse events (TEAEs) (clinical and laboratory), and discontinuation from trial due to AEs.;Timepoint(s) of evaluation of this end point: Throughout the course of the trial. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary safety endpoints are as follows: • Mean change from baseline and incidence of clinically significant abnormalities in clinical laboratory tests and urinalysis results (including fasting blood lipids, glucose and insulin, serum prolactin, glycosylated hemoglobin [HbA1c] and creatine phosphokinase [CPK]), vital signs (supine and standing positions), weight, height, body mass index (BMI), waist circumference, and ECG parameters • Mean change from baseline on the AIMS, Simpson-Angus Scale (SAS), and Barnes Akathisia Rating Scale (BARS) • Analysis of potential suicide events recorded on the C SSRS • Comprehensive psychotropic side effects as assessed by UKU side effect rating scale • The frequency of symptom items for the clinician-administered NY-AACENT • Baseline and postbaseline Tanner Staging Scale data • Time to discontinuation due to AE The secondary efficacy endpoints are as follows: • Change in the PANSS Total Score and the Positive and Negative Subscale Scores • Change in the CGAS Score ;Timepoint(s) of evaluation of this end point: baseline and post baseline | — |
Countries
Bulgaria, Colombia, France, Hungary, Italy, Mexico, Poland, Romania, Russian Federation, Serbia, Spain, Ukraine, United States
Contacts
Public ContactLaurie Stallings
Otsuka Pharmaceutical Development & Commercialization, Inc
Outcome results
None listed