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

Dr. Albert Kar-Kin Chung

Status: Enrolling

Conditions: Psychosis; Depression

Treatments: Drug: Brexpiprazole

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05962216

ReSD-HK

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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)