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

NCT04641780 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2020-12-01

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Otsuka Pharmaceutical, Inc., Philippines

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-17
Primary Completion
2023-06-30
Completion
2024-03-31

Countries

  • Philippines

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04641780 on ClinicalTrials.gov