"Brexpiprazole (Rexulti™) Safety and Efficacy Among Filipino Patients (RAISE) - A Post Marketing Surveillance Program"
"Brexpiprazole (Rexulti™) Safety and Efficacy Among Filipino Patients (RAISE) - A Post Marketing Surveillance Program"
The objective of this post marketing surveillance is to further gather local data on the
 safety and efficacy of Brexpiprazole (RexultiTM) Film-coated Tablet in the treatment of
 schizophrenia and adjunctive therapy of Major Depressive Disorder.
DESIGN OF THE PMS:

 This is a post marketing surveillance of 8 weeks duration, on 300 male or female patients
 diagnosed to have schizophrenia and MDD in the Philippines.

 PROCEDURES:

 Based on his clinical decision, the attending physician will enroll patients with
 schizophrenia and MDD to the program. The attending physician will explain to the patient or
 his legal guardian the purpose of the PMS and will obtain the patient or legal guardian's
 consent that Brexpiprazole (Rexulti) Film-coated Tablet will be administered.

 Data on the safety aspects of Brexpiprazole (Rexulti) Film-coated Tablet will be collected in
 terms of adverse events. Efficacy will be measured using the Clinical Global Impression (CGI)
 Scale (Severity and Improvement).

 Assessments will be done upon initiation, (Baseline visit), 4 weeks later (Visit 2), until
 completion of the study week 8 (Study Completion). Demographic information and vital signs
 will be collected.

 DOSAGE AND ADMINISTRATION:

 For the treatment of schizophrenia, the recommended starting dosage for Brexpiprazole
 (Rexulti™) is 1 mg once daily on Days 1 to 4, taken orally with or without food. The
 recommended target dosage is 2 mg to 4 mg once daily. Titrate to 2 mg once daily on Day 5
 through Day 7, then to 4 mg on Day 8 based on the patient's clinical response and
 tolerability. The maximum recommended daily dosage is 4 mg.

 The recommended starting dosage as adjunctive therapy for MDD is 0.5 mg or 1 mg once daily,
 taken orally with or without food. Titrate to 1 mg once daily, then up to the target dosage
 of 2 mg once daily. Dosage increases should occur at weekly intervals based on the patient's
 clinical response and tolerability. The maximum recommended daily dosage is 3 mg. It must be
 periodically reassess to determine the continued need and appropriate dosage for treatment.

 For patients with moderate to severe hepatic impairment (Child-Pugh score ≥7), the maximum
 recommended dosage is 2 mg once daily for patients with MDD, and 3 mg once daily for patients
 with schizophrenia.

 For patients with moderate, severe or end-stage renal impairment (creatinine clearance
 CLcr<60 mL/minute), the maximum recommended dosage is 2 mg once daily for patients with MDD
 and 3 mg once daily for patients with schizophrenia.

 STATISTICAL ANALYSIS:

 Analysis of data will be limited to descriptive statistics only. Safety will be evaluated
 based on the reported AEs per assessment. Efficacy will be evaluated using the Clinical
 Global Impression-Severity (CGI-S) and Clinical Global Impression-Improvement (CGI-I) Scales
 to monitor severity and improvement from mean baseline score (before initial dose) up to the
 last assessment (Week 8 - Study Completion).
Inclusion Criteria:

 -  A total of 300 subjects will be included in the trial

 -  Adults (18 years old and above)

 -  Male and Female

 Exclusion Criteria:

 -  N/A