Real-life Assessment of Brexpiprazole (Rexulti) in Schizophrenia and in Depressive Disorders (ReSD)

Real-life Assessment of Brexpiprazole (Rexulti) in Schizophrenia and in Depressive Disorders: a Naturalistic Non-interventional Prospective Follow-up Study

Not only being the mainstay of treatment for schizophrenia spectrum psychotic disorders, antipsychotics, especially the second-generation antipsychotics (SGAs) have also been recommended as augmenting agents for treating depression. Dopaminergic agents, including both dopamine D2/D3 antagonists and dopamine partial D2 agonists, have been effective for treating psychosis and schizophrenia. Amongst all SGAs, those with partial D2 agonistic property are generally acknowledged to have better side-effect profiles with lower incidence of extrapyramidal side-effects, prolactin increase, weight gain, QTc prolongation, and metabolic syndrome, as well as more efficacious in alleviating depressive symptoms. Up-to-date, three SGAs, namely aripiprazole, brexpiprazole and cariprazine, are known to possess such partial D2 agonism. ReSD-HK study is part of the ReSD Asian Study aiming to carefully evaluate a cohort of patients prescribed with brexpiprazole on its efficacy and tolerability as treatment for schizophrenia and/or depression in a real-life clinical setting.

Study Overview

• Status: Recruiting
• Conditions: Depression; Psychosis
• Intervention / Treatment: Drug: Brexpiprazole

Detailed Description

This is a 6-month, non-interventional, prospective naturalist study that adult patients (18-65 years old) receiving brexpiprazole for treatment of psychosis and/or as adjunctive treatment for major depressive disorder are eligible to participate. Minimal exclusion criteria are employed to fit the usual real-life setting.

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Albert KK Chung, MBBS; Phone Number: 2255 4486; Email: Chungkka@hku.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong, 000000
    • Recruiting
    • Queen Mary Hospital
    • Contact: Albert KK Chung; Phone Number: 2255 4486; Email: chungkka@hku.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Subjects suffering from psychosis or depressive disorders who are treated with the oral medication, brexpiprazole

Description

Inclusion Criteria:

• Age: 18- 65 years old at the time of enrollment
• Able to read and communicate in English and/or Chinese
• Able to give informed consent
• Has been diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5), or International Statistical Classification of Diseases and Related Health Problems 10th revision (ICD-10) to have either Psychotic Disorders (F10-F19.5, F20-23, F25, F32-F33)
• is receiving brexpiprazole as treatment for less than 4 weeks at the time of recruitment

Exclusion Criteria:

• Age <18 years old
• Unable to read English or Chinese
• Unable to give informed consent
• Had been diagnosed to have Intellectual Disabilities (DSM-5) or Mental Retardation (ICD-10 F70-73)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Brief Psychiatric Rating Scale-24 in 6 months	Efficacy measures the change from baseline, to that at 3rd and 6th months	6 months
Change in Clinical Global Impression in 6 months	Efficacy measures the change from baseline, to that at 3rd and 6th months	6 months
Change in Beck Anxiety Inventory in 6 months	Efficacy measures the change from baseline, to that at 3rd and 6th months	6 months
Change in Beck Depression Inventory in 6 months	Efficacy measures the change from baseline, to that at 3rd and 6th months	6 months
Change in Digital Symbol Substitution Test in 6 months	Efficacy measures the change from baseline, to that at 3rd and 6th months	6 months
Change in World Health Organization Disability Assessment Schedule 2.0 in 6 months	Efficacy measures the change from baseline, to that at 3rd and 6th months	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glasgow Antipsychotic Side-effects Scale in 6 months	Tolerability measures at baseline, at 3rd and 6th months. Higher score means greater side-effects with the minimum score of 0 and the maximum score of 63.	6 months
Simpson-Angus Scale in 6 months	Tolerability measures at baseline, at 3rd and 6th months. The cut-off score is 3.	6 months
Barnes Akathisia Rating Scale in 6 months	Tolerability measures at baseline, at 3rd and 6th months. The cut-off score is 2.	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
QTc interval	Tolerability measures at baseline and 6th months	6 months

Collaborators and Investigators

• Sponsor: Dr. Albert Kar-Kin Chung
• Collaborators: Otsuka Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: July 3, 2023
• First Submitted That Met QC Criteria: July 18, 2023
• First Posted (Actual): July 27, 2023

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 18, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Depressive Disorder; Schizophrenia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Serotonin Agents; Dopamine Agonists; Dopamine Agents; Brexpiprazole
• Other Study ID Numbers: ReSD-HK

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: To be shared within the ReSD Asian Study Group
• IPD Sharing Time Frame: Five year after the study period upon the last subject recruitments in the respective study sites.
• IPD Sharing Access Criteria: For those named investigator who are engaged in the ReSD Asian Study with agreement signed.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes