PsychosisReSDNCT05962216
Real-life Assessment of Brexpiprazole (Rexulti) in Schizophrenia and in Depressive Disorders
An observational study of Psychosis and Depression, run by Dr. Albert Kar-Kin Chung at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Psychosis, Depression
- What is being tested?
- Brexpiprazole
- How many people
- 40 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jul 2023to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
Study population: Subjects suffering from psychosis or depressive disorders who are treated with the oral medication, brexpiprazole
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Queen Mary Hospital
Hong Kong, 000000
Albert KK Chung, 2255 4486, chungkka@hku.hk
About this study
Official title: Real-life Assessment of Brexpiprazole (Rexulti) in Schizophrenia and in Depressive Disorders: a Naturalistic Non-interventional Prospective Follow-up Study
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.
Read the 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.
- Conditions
- Psychosis, Depression
- Being tested
- Brexpiprazole
- Medical subject headings
- Psychotic Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrexpiprazoleDrug
Also called Rexulti
Brexpiprazole as treatment for psychosis and schizophrenia, and/or as augmentation treatment for depressive disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Brief Psychiatric Rating Scale-24 in 6 months
Efficacy measures the change from baseline, to that at 3rd and 6th months
Measured: 6 months
Change in Clinical Global Impression in 6 months
Efficacy measures the change from baseline, to that at 3rd and 6th months
Measured: 6 months
Change in Beck Anxiety Inventory in 6 months
Efficacy measures the change from baseline, to that at 3rd and 6th months
Measured: 6 months
Change in Beck Depression Inventory in 6 months
Efficacy measures the change from baseline, to that at 3rd and 6th months
Measured: 6 months
Change in Digital Symbol Substitution Test in 6 months
Efficacy measures the change from baseline, to that at 3rd and 6th months
Measured: 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
Measured: 6 months
Secondary outcomes (3)
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.
Measured: 6 months
Simpson-Angus Scale in 6 months
Tolerability measures at baseline, at 3rd and 6th months. The cut-off score is 3.
Measured: 6 months
Barnes Akathisia Rating Scale in 6 months
Tolerability measures at baseline, at 3rd and 6th months. The cut-off score is 2.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start1 Jul 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsychosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Albert Kar-Kin Chung
- Sponsor type
- University, hospital or other
- Collaborators
- Otsuka Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor-investigator, Dr. Albert Kar-Kin Chung, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05962216
- Sponsor's protocol ID
- ReSD-HK
- Acronym
- ReSD
- Status last verified
- Jul 2025
- First submitted
- 3 Jul 2023
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: To be shared within the ReSD Asian Study Group
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-life Assessment of Brexpiprazole (Rexulti) in Schizophrenia and in Depressive Disorders: a Naturalistic Non-interventional Prospective Follow-up Study
- ClinicalTrials.gov ID
- NCT05962216
- Acronym / sponsor ID
- ReSD / ReSD-HK
- Conditions
- Psychosis, Depression
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Dr. Albert Kar-Kin ChungUniversity, hospital or other
- Collaborators
- Otsuka Pharmaceutical Co., Ltd.
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Subjects suffering from psychosis or depressive disorders who are treated with the oral medication, brexpiprazole
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BrexpiprazoleAlso: RexultiBrexpiprazole as treatment for psychosis and schizophrenia, and/or as augmentation treatment for depressive disorders | Drug | – |
Primary outcome
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
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
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
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
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
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
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
- Individual participant dataSharing planned: Yes. To be shared within the ReSD Asian Study Group
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychosis and Depression, run by Dr. Albert Kar-Kin Chung at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Albert KK Chung, MBBS (2255 4486, Chungkka@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Brief Psychiatric Rating Scale-24 in 6 months (time frame: 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.