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NCT Number: NCT05962216

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

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.

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Key information

Conditions

Psychosis Behavior Behavioral Symptoms Depression Mental Disorders Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Queen Mary Hospital

Hong Kong, 000000

Location status: Recruiting

Location contact

Albert KK Chung

CONTACT

[email protected]

2255 4486

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Brexpiprazole

Drug

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

Other names: Rexulti

Primary outcomes

  1. Change in Brief Psychiatric Rating Scale-24 in 6 months

    Time frame: 6 months

    Efficacy measures the change from baseline, to that at 3rd and 6th months

  2. Change in Clinical Global Impression in 6 months

    Time frame: 6 months

    Efficacy measures the change from baseline, to that at 3rd and 6th months

  3. Change in Beck Anxiety Inventory in 6 months

    Time frame: 6 months

    Efficacy measures the change from baseline, to that at 3rd and 6th months

  4. Change in Beck Depression Inventory in 6 months

    Time frame: 6 months

    Efficacy measures the change from baseline, to that at 3rd and 6th months

  5. Change in Digital Symbol Substitution Test in 6 months

    Time frame: 6 months

    Efficacy measures the change from baseline, to that at 3rd and 6th months

  6. Change in World Health Organization Disability Assessment Schedule 2.0 in 6 months

    Time frame: 6 months

    Efficacy measures the change from baseline, to that at 3rd and 6th months

Secondary outcomes

  1. Glasgow Antipsychotic Side-effects Scale in 6 months

    Time frame: 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.

  2. Simpson-Angus Scale in 6 months

    Time frame: 6 months

    Tolerability measures at baseline, at 3rd and 6th months. The cut-off score is 3.

  3. Barnes Akathisia Rating Scale in 6 months

    Time frame: 6 months

    Tolerability measures at baseline, at 3rd and 6th months. The cut-off score is 2.

Other outcomes

  1. QTc interval

    Time frame: 6 months

    Tolerability measures at baseline and 6th months

Study contacts

Contact information is provided by the study sponsor or research team.

Albert KK Chung, MBBS

CONTACT

[email protected]

2255 4486

Sponsors and collaborators

Lead sponsor

Dr. Albert Kar-Kin Chung

Other

Collaborators

  • Otsuka Pharmaceutical Co., Ltd.

Registry information

Official study title

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

Acronym: ReSD

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jul 27, 2023
Registry last updated
Jul 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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