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

Depression Clinical Trial

— ReSD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05962216
• Other study ID #: ReSD-HK
• Status: Recruiting
• Start date: July 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: July 2023
• Source: The University of Hong Kong
• Contact: Albert KK Chung, MBBS
• Phone: 2255 4486
• Email: Chungkka[@]hku.hk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Psychosis
• Schizophrenia

Intervention

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

Locations

Country	Name	City	State
Hong Kong	Queen Mary Hospital	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
Dr. Albert Kar-Kin Chung	Otsuka Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	QTc interval	Tolerability measures at baseline and 6th months	6 months
Primary	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
Primary	Change in Clinical Global Impression in 6 months	Efficacy measures the change from baseline, to that at 3rd and 6th months	6 months
Primary	Change in Beck Anxiety Inventory in 6 months	Efficacy measures the change from baseline, to that at 3rd and 6th months	6 months
Primary	Change in Beck Depression Inventory in 6 months	Efficacy measures the change from baseline, to that at 3rd and 6th months	6 months
Primary	Change in Digital Symbol Substitution Test in 6 months	Efficacy measures the change from baseline, to that at 3rd and 6th months	6 months
Primary	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	Glasgow Antipsychotic Side-effects Scale in 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.	6 months
Secondary	Simpson-Angus Scale in 6 months	Tolerability measures at baseline, at 3rd and 6th months. The cut-off score is 3.	6 months
Secondary	Barnes Akathisia Rating Scale in 6 months	Tolerability measures at baseline, at 3rd and 6th months. The cut-off score is 2.	6 months