"Brexpiprazole (Rexulti™) Safety and Efficacy Among Filipino Patients (RAISE) - A Post Marketing Surveillance Program"
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Safety assessment of patients with Schizophrenia and Major Depressive Disorder
Study Overview
Brief Summary
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.
Detailed Description
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).
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •A total of 300 subjects will be included in the trial
- •Adults (18 years old and above)
- •Male and Female
Exclusion Criteria
- Not provided
Arms & Interventions
Rexulti Tablets
Target is 300 patients in the Philippines diagnosed with Schizophrenia and Major Depressive Disorder
Intervention: Brexpiprazole (Drug)
Outcomes
Primary Outcomes
Safety assessment of patients with Schizophrenia and Major Depressive Disorder
Time Frame: 8 weeks treatment duration
Safety of Brexpiprazole (Rexulti™) Film-coated Tablet will be evaluated based on the reported AE's per assessment.
Secondary Outcomes
- Efficacy assessment of patients with Schizophrenia and Major Depressive Disorder using Clinical Global Impression (CGI) Scale(8 weeks treatment duration)