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Recruiting NCT05962216

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

— Observational Psychosis Depression

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Brexpiprazole.
Who it may be relevant to
Registry conditions: Psychosis, Depression. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Drug Brexpiprazole
    Brexpiprazole as treatment for psychosis and schizophrenia, and/or as augmentation treatment for depressive disorders

Primary outcome measures

  • Change in Brief Psychiatric Rating Scale-24 in 6 months [Time frame: 6 months]
  • Change in Clinical Global Impression in 6 months [Time frame: 6 months]
  • Change in Beck Anxiety Inventory in 6 months [Time frame: 6 months]
  • Change in Beck Depression Inventory in 6 months [Time frame: 6 months]
  • Change in Digital Symbol Substitution Test in 6 months [Time frame: 6 months]
  • Change in World Health Organization Disability Assessment Schedule 2.0 in 6 months [Time frame: 6 months]
Secondary outcome measures (3)
  • Glasgow Antipsychotic Side-effects Scale in 6 months [Time frame: 6 months]
  • Simpson-Angus Scale in 6 months [Time frame: 6 months]
  • Barnes Akathisia Rating Scale in 6 months [Time frame: 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

Hong Kong · 1 center
  • Queen Mary Hospital — Hong Kong

Identifiers

NCT: NCT05962216 · ReSD-HK

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗