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"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
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical, Inc., Philippines

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.

Condition or disease Intervention/treatment
Schizophrenia Major Depressive Disorder Drug: Brexpiprazole

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).

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).

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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)



Information from the National Library of Medicine

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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
Study Population
A total of 300 patients in the Philippines diagnosed with Schizophrenia and Major Depressive Disorder
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Fatima Perey, RPh 09998869874 fperey@otsuka.com.ph

Locations
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Philippines
Otsuka (Philippines) Pharmaceutical Inc. Recruiting
Makati City, Metro Manila, Philippines, 1231
Contact: Fatima Perey, RPh    09998859874      
Sponsors and Collaborators
Otsuka Pharmaceutical, Inc., Philippines
  Study Documents (Full-Text)

Documents provided by Otsuka Pharmaceutical, Inc., Philippines:
Study Protocol  [PDF] November 12, 2020

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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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