"Brexpiprazole (Rexulti™) Safety and Efficacy Among Filipino Patients (RAISE) - A Post Marketing Surveillance Program"
NCT ID: NCT04641780
Last Updated: 2020-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
300 participants
OBSERVATIONAL
2019-08-17
2024-03-31
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Rexulti Tablets
Target is 300 patients in the Philippines diagnosed with Schizophrenia and Major Depressive Disorder
Brexpiprazole
For the treatment of schizophrenia, the recommended starting dosage for Rexulti™ is 1 mg once daily on Days 1 to 4, taken orally with or without food. The recommended target Rexulti™ 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 for Rexulti™ 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.
Interventions
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Brexpiprazole
For the treatment of schizophrenia, the recommended starting dosage for Rexulti™ is 1 mg once daily on Days 1 to 4, taken orally with or without food. The recommended target Rexulti™ 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 for Rexulti™ 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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Adults (18 years old and above)
* Male and Female
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Otsuka Pharmaceutical, Inc., Philippines
INDUSTRY
Responsible Party
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Locations
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Otsuka (Philippines) Pharmaceutical Inc.
Makati City, National Capital Region, Philippines
Countries
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Central Contacts
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Facility Contacts
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Fatima Perey, RPh
Role: primary
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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331-414-00243
Identifier Type: -
Identifier Source: org_study_id