"Brexpiprazole (Rexulti™) Safety and Efficacy Among Filipino Patients (RAISE) - A Post Marketing Surveillance Program"

Schizophrenia Clinical Trial

— RAISE  

Official title:

"Brexpiprazole (Rexulti™) Safety and Efficacy Among Filipino Patients (RAISE) - A Post Marketing Surveillance Program"

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04641780
• Other study ID #: 331-414-00243
• Status: Recruiting
• Start date: August 17, 2019
• Est. completion date: March 2024

Study information

• Verified date: November 2020
• Source: Otsuka Pharmaceutical, Inc., Philippines
• Contact: Fatima Perey, RPh
• Phone: 09998869874
• Email: fperey[@]otsuka.com.ph
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: March 2024
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder
• Schizophrenia

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Philippines	Otsuka (Philippines) Pharmaceutical Inc.	Makati City	Metro Manila

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical, Inc., Philippines

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety assessment of patients with Schizophrenia and Major Depressive Disorder	Safety of Brexpiprazole (Rexulti™) Film-coated Tablet will be evaluated based on the reported AE's per assessment.	8 weeks treatment duration
Secondary	Efficacy assessment of patients with Schizophrenia and Major Depressive Disorder using Clinical Global Impression (CGI) Scale	Efficacy of Brexpiprazole (Rexulti™) Film-coated Tablet will be evaluated using the Clinical Global Impression (CGI) Scale: CGI - Severity; Numbers and proportions of responders (defined as patients with CGI severity (CGI-S) score of 1 (normal, not at all ill), 2 (borderline mentally ill), 3 (mildly ill), 4 (moderately ill), 5 (markedly ill), 6 (severely ill), 7 (among the most extremely ill patients) CGI - Improvement; Numbers and proportions of responders (defined as patients with CGI improvement (CGI-I) score of 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse), 7 (very much worse)	8 weeks treatment duration