Clinical trial NCT05962216: Real-life Assessment of Brexpiprazole (Rexulti) in Schizophrenia and in Depressive Disorders
Official title: Real-life Assessment of Brexpiprazole (Rexulti) in Schizophrenia and in Depressive Disorders: a Naturalistic Non-interventional Prospective Follow-up Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Psychosis
Depression
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Otsuka Pharmaceutical Co., Ltd.
First posted: 2023-07-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects suffering from psychosis or depressive disorders who are treated with the oral medication, brexpiprazole

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.

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.

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)

Primary outcomes:
measure: Change in Brief Psychiatric Rating Scale-24 in 6 months
timeFrame: 6 months
measure: Change in Clinical Global Impression in 6 months
timeFrame: 6 months
measure: Change in Beck Anxiety Inventory in 6 months
timeFrame: 6 months
measure: Change in Beck Depression Inventory in 6 months
timeFrame: 6 months
measure: Change in Digital Symbol Substitution Test in 6 months
timeFrame: 6 months
measure: Change in World Health Organization Disability Assessment Schedule 2.0 in 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Glasgow Antipsychotic Side-effects Scale in 6 months
timeFrame: 6 months
measure: Simpson-Angus Scale in 6 months
timeFrame: 6 months
measure: Barnes Akathisia Rating Scale in 6 months
timeFrame: 6 months
Other outcomes:
measure: QTc interval
timeFrame: 6 months
Locations:
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
Study officials:
References: