Clinical trial

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

Name
ReSD-HK
Description
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.
Trial arms
Trial start
2023-07-01
Estimated PCD
2025-12-31
Trial end
2025-12-31
Status
Recruiting
Treatment
Brexpiprazole
Brexpiprazole as treatment for psychosis and schizophrenia, and/or as augmentation treatment for depressive disorders
Other names:
Rexulti
Size
40
Primary endpoint
Change in Brief Psychiatric Rating Scale-24 in 6 months
6 months
Change in Clinical Global Impression in 6 months
6 months
Change in Beck Anxiety Inventory in 6 months
6 months
Change in Beck Depression Inventory in 6 months
6 months
Change in Digital Symbol Substitution Test in 6 months
6 months
Change in World Health Organization Disability Assessment Schedule 2.0 in 6 months
6 months
Eligibility criteria
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)
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}
Updated at
2023-07-27

1 organization

1 product

2 indications

Indication
Psychosis