ReSD: Real-life Assessment of Brexpiprazole (Rexulti) in Schizophrenia and in Depressive Disorders
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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 Design
Outcome Measures
Primary Outcome Measures
- Change in Brief Psychiatric Rating Scale-24 in 6 months [6 months]
Efficacy measures the change from baseline, to that at 3rd and 6th months
- Change in Clinical Global Impression in 6 months [6 months]
Efficacy measures the change from baseline, to that at 3rd and 6th months
- Change in Beck Anxiety Inventory in 6 months [6 months]
Efficacy measures the change from baseline, to that at 3rd and 6th months
- Change in Beck Depression Inventory in 6 months [6 months]
Efficacy measures the change from baseline, to that at 3rd and 6th months
- Change in Digital Symbol Substitution Test in 6 months [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 [6 months]
Efficacy measures the change from baseline, to that at 3rd and 6th months
Secondary Outcome Measures
- Glasgow Antipsychotic Side-effects Scale in 6 months [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 [6 months]
Tolerability measures at baseline, at 3rd and 6th months. The cut-off score is 3.
- Barnes Akathisia Rating Scale in 6 months [6 months]
Tolerability measures at baseline, at 3rd and 6th months. The cut-off score is 2.
Other Outcome Measures
- QTc interval [6 months]
Tolerability measures at baseline and 6th months
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age: 18- 65 years old at the time of enrollment
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Able to read and communicate in English and/or Chinese
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Able to give informed consent
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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)
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is receiving brexpiprazole as treatment for less than 4 weeks at the time of recruitment
Exclusion Criteria:
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Age <18 years old
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Unable to read English or Chinese
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Unable to give informed consent
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Had been diagnosed to have Intellectual Disabilities (DSM-5) or Mental Retardation (ICD-10 F70-73)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Queen Mary Hospital | Hong Kong | Hong Kong | 000000 |
Sponsors and Collaborators
- Dr. Albert Kar-Kin Chung
- Otsuka Pharmaceutical Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ReSD-HK