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

NCT05962216 | Recruiting FDA Drug

• 1 other identifier: ReSD-HK
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychosis; Depression

Outcome Measures

Primary Outcomes (6)

• 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

Secondary Outcomes (3)

• Glasgow Antipsychotic Side-effects Scale in 6 months

  6 months

• Simpson-Angus Scale in 6 months

  6 months

• Barnes Akathisia Rating Scale in 6 months

  6 months

Other Outcomes (1)

• QTc interval

  6 months

Interventions

Brexpiprazole DRUG

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

Also known as: Rexulti

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects suffering from psychosis or depressive disorders who are treated with the oral medication, brexpiprazole

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Dr. Albert Kar-Kin Chung: lead
• Otsuka Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Queen Mary Hospital

Hong Kong, 000000, Hong Kong

RECRUITING

MeSH Terms

Conditions

Psychotic Disorders; Depression

Interventions

brexpiprazole

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Central Study Contacts

Albert KK Chung, MBBS

CONTACT

2255 4486; Chungkka@hku.hk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: July 3, 2023
• First Posted: July 27, 2023
• Study Start: July 1, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Five year after the study period upon the last subject recruitments in the respective study sites.
• Access Criteria: For those named investigator who are engaged in the ReSD Asian Study with agreement signed.

Locations

HK (1)