"Brexpiprazole (Rexulti™) Safety and Efficacy Among Filipino Patients (RAISE) - A Post Marketing Surveillance Program" (RAISE)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04641780 |
|
Recruitment Status :
Recruiting
First Posted : November 24, 2020
Last Update Posted : December 1, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment |
|---|---|
| Schizophrenia Major Depressive Disorder | Drug: Brexpiprazole |
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).
| Study Type : | Observational |
| Estimated Enrollment : | 300 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | "Brexpiprazole (Rexulti™) Safety and Efficacy Among Filipino Patients (RAISE) - A Post Marketing Surveillance Program" |
| Actual Study Start Date : | August 17, 2019 |
| Estimated Primary Completion Date : | June 2023 |
| Estimated Study Completion Date : | March 2024 |
| Group/Cohort | Intervention/treatment |
|---|---|
|
Rexulti Tablets
Target is 300 patients in the Philippines diagnosed with Schizophrenia and Major Depressive Disorder
|
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. Other Name: Rexulti |
- 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.
- Efficacy assessment of patients with Schizophrenia and Major Depressive Disorder using Clinical Global Impression (CGI) Scale [ Time Frame: 8 weeks treatment duration ]
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)
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04641780
| Contact: Fatima Perey, RPh | 09998869874 | fperey@otsuka.com.ph |
| Philippines | |
| Otsuka (Philippines) Pharmaceutical Inc. | Recruiting |
| Makati City, Metro Manila, Philippines, 1231 | |
| Contact: Fatima Perey, RPh 09998859874 | |
Documents provided by Otsuka Pharmaceutical, Inc., Philippines:
| Responsible Party: | Otsuka Pharmaceutical, Inc., Philippines |
| ClinicalTrials.gov Identifier: | NCT04641780 |
| Other Study ID Numbers: |
331-414-00243 |
| First Posted: | November 24, 2020 Key Record Dates |
| Last Update Posted: | December 1, 2020 |
| Last Verified: | November 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
|
Schizophrenia Depressive Disorder Depressive Disorder, Major Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders Mood Disorders Brexpiprazole |
Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Dopamine Agonists Dopamine Agents |