Real-life Assessment of Brexpiprazole (Rexulti) in Schizophrenia and in Depressive Disorders
ID: NCT05962216
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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.
Read Full Scientific Objectives & Methods
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.
Brexpiprazole as treatment for psychosis and schizophrenia, and/or as augmentation treatment for depressive disorders
- 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
- 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)
Primary Outcome Measures
- Change in Brief Psychiatric Rating Scale-24 in 6 months — Time Frame: 6 months
Efficacy measures the change from baseline, to that at 3rd and 6th months
- Change in Clinical Global Impression in 6 months — Time Frame: 6 months
Efficacy measures the change from baseline, to that at 3rd and 6th months
- Change in Beck Anxiety Inventory in 6 months — Time Frame: 6 months
Efficacy measures the change from baseline, to that at 3rd and 6th months
- Change in Beck Depression Inventory in 6 months — Time Frame: 6 months
Efficacy measures the change from baseline, to that at 3rd and 6th months
- Change in Digital Symbol Substitution Test in 6 months — Time Frame: 6 months
Efficacy measures the change from baseline, to that at 3rd and 6th months
- Change in World Health Organization Disability Assessment Schedule 2.0 in 6 months — Time Frame: 6 months
Efficacy measures the change from baseline, to that at 3rd and 6th months
View Secondary Outcome Measures (3)
- Glasgow Antipsychotic Side-effects Scale in 6 months — Time Frame: 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.
- Simpson-Angus Scale in 6 months — Time Frame: 6 months
Tolerability measures at baseline, at 3rd and 6th months. The cut-off score is 3.
- Barnes Akathisia Rating Scale in 6 months — Time Frame: 6 months
Tolerability measures at baseline, at 3rd and 6th months. The cut-off score is 2.
This trial is recruiting at 1 study facilities worldwide. Click below to see if there is a clinic or hospital in your area:
Show All 1 Facilities & Contact Sites
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View Official Medical/Scientific Title
Real-life Assessment of Brexpiprazole (Rexulti) in Schizophrenia and in Depressive Disorders: a Naturalistic Non-interventional Prospective Follow-up Study