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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Psychosis, Depression

Intervention / Treatment
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* Drug: Brexpiprazole


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Brexpiprazole|Brexpiprazole as treatment for psychosis and schizophrenia, and/or as augmentation treatment for depressive disorders|

What is the study measuring?
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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 |