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| Name | Class |
|---|---|
| Otsuka Pharmaceutical Co., Ltd. | INDUSTRY |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brexpiprazole | Drug | Brexpiprazole as treatment for psychosis and schizophrenia, and/or as augmentation treatment for depressive disorders |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| QTc interval | Tolerability measures at baseline and 6th months | 6 months |
Inclusion Criteria:
Exclusion Criteria:
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Subjects suffering from psychosis or depressive disorders who are treated with the oral medication, brexpiprazole
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Albert KK Chung, MBBS | Contact | 2255 4486 | Chungkka@hku.hk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Mary Hospital | Recruiting | Hong Kong | 000000 | Hong Kong |
To be shared within the ReSD Asian Study Group
Five year after the study period upon the last subject recruitments in the respective study sites.
For those named investigator who are engaged in the ReSD Asian Study with agreement signed.
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| ID | Term |
|---|---|
| D011618 | Psychotic Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| C000591922 | brexpiprazole |
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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 |