Schizophrenia and Related DisordersMainRexultNCT05169268
Real-life Assessment of Abilify Maintena + Rexult in Schizophrenia
An observational study of Schizophrenia and Related Disorders and Anxiety Depression, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
MainRexult study aims to carefully evaluate a cohort of patients with schizophrenia and related disorder prescribed with the combination therapy with Abilify Maintena and Rexulti on its efficacy and tolerability in a real-life clinical setting. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia and Related Disorders, Anxiety Depression
- What is being tested?
- ARIPiprazole Injection [Abilify] and Brexpiprazole
- Type of treatment
- Injection or infusion
- How many people
- 6 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Feb 2022to 31 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 are diagnosed with schizophrenia and related disorders who are receiving Abilify Maintena and Brexpiprazole as treatment.
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 to have Schizophrenia (DSM-5 or ICD-10 F20 [except F20.81], Schizotypal (Personality) Disorder (DSM-5 or ICD-10 F21), or Schizoaffective Disorder (DSM-5 or ICD-10 F25), (Persistent) Delusional Disorder (DSM-5 or ICD-10 F22), Schizophreniform Disorder (DSM-5 or ICD-10 F20.81), Brief Psychotic Disorder (DSM-5) or Acute and Transient Psychotic Disorder (ICD-10 F23)
- Is receiving the combination with Abilify Maintena and brexpiprazole as treatment ≤8 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.
About this study
Official title: Real-life Assessment of Aripiprazole Long-acting Injection (Abilify Maintena) Combined With Brexpiprazole (Rexulti) in Schizophrenia: a Naturalistic Non-interventional Prospective Follow-up Study
MainRexult study aims to carefully evaluate a cohort of patients with schizophrenia and related disorder prescribed with the combination therapy with Abilify Maintena and Rexulti on its efficacy and tolerability in a real-life clinical setting.
Read the detailed description
Currently, there is no recommendation on next-step treatment strategy if the patients remain suffering from residual symptoms, have incomplete remission, or have acute exacerbation of schizophrenia whilst receiving aripiprazole long acting injection at its recommended (maximum) dose, except to switch to other second generation antipsychotics (SGA) or to clozapine if they are in their treatment-resistant course. Such practice may incur risks of full relapse and/or unnecessary side effects to the patients, in particularly to those already showed insufficient treatment response, intolerability to side effects, or non-adherence to other antipsychotics before. On the contrary, adding another SGAs to this special cohort appears to be rational. Especially, brexpiprazole might be an ideal choice for its serotonin-dopamine activity modulator property to achieve better symptom control, and at the same time retaining the benefits from the lower incidence of side effects than other SGAs.
Cases reports on combination therapy with aripiprazole (oral or LAI) with brexpiprazole had demonstrated initial favorable outcomes, albeit lacking empirical evidence from randomized controlled trial or longer term follow-up study. Therefore, the current MainRexult study aims to carefully evaluate a cohort of patients with schizophrenia and related disorders prescribed with the combination therapy with Abilify Maintena and Rexulti on its efficacy and tolerability in an non-interventional, naturalistic real-life clinical setting.
- Being tested
- ARIPiprazole Injection [Abilify], Brexpiprazole
- Keywords
- Schizophrenia, Antipsychotics, Aripiprazole, Brexpiprazole
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARIPiprazole Injection [Abilify]Drug
Also called Abilify Maintena
subject already receiving the combination of Abilify Maintena and Rexulti
BrexpiprazoleDrug
Also called Rexulti
subject already receiving the combination of Abilify Maintena and Rexulti
| Study group | Role | What they receive |
|---|---|---|
| MainRexult Group | Subjects with schizophrenia and related disorders receiving Abilify Maintena (aripiprazole 1 monthly depot) together with Rexulti (Brexpiprazole) Receives: Drug: ARIPiprazole Injection [Abilify]; Drug: Brexpiprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline score of the Brief Psychiatric Rating Scale-24 at 3rd and 6th months
Measuring efficacy on positive and negative psychotic symptoms with a total score ranges from 24 (normal) to 168 (severe ill)
Measured: 6 months
Change from baseline score of the Clinical Global Impression Scale at 3rd and 6th months
measuring efficacy on overall clinical improvement and severity of subjects with a score ranges from 0 (normal) to 18 (severely ill)
Measured: 6 months
Change from baseline score of the Hamilton Anxiety Rating Scale at 3rd and 6th months
measuring anxiety symptoms of the subjects with a score ranges from 0 (not ill) to 56 (severe)
Measured: 6 months
Change from basline score of the Hamilton Depression Rating Scale at 3rd and 6th months
measuring depressive symptoms of the subjects with a score ranges from 0 (normal) to 62 (very severe)
Measured: 6 months
Secondary outcomes (2)
Change from basline score of the Simpson Angus Score at 3rd and 6th months
for intolerability assessment on extra-pyramidal side effects of the subjects from 0 (not present) to 24 (most severe)
Measured: 6 months
Change from baseline score of the Barnes Akathisia Rating Scale at 3rd and 6th months
for intolerability assessment on akathisia of the subjects from 0 (not present) to 14 (severe)
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 posted23 Dec 2021
- Study start1 Feb 2022
- Primary completion31 Jan 2026
- Study completion31 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia and Related DisordersStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- 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
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Albert KK Chung, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05169268
- Sponsor's protocol ID
- UW-21-734
- Acronym
- MainRexult
- Status last verified
- Jul 2025
- First submitted
- 26 Nov 2021
- Last updated
- 27 Apr 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-life Assessment of Aripiprazole Long-acting Injection (Abilify Maintena) Combined With Brexpiprazole (Rexulti) in Schizophrenia: a Naturalistic Non-interventional Prospective Follow-up Study
- ClinicalTrials.gov ID
- NCT05169268
- Acronym / sponsor ID
- MainRexult / UW-21-734
- Keywords
- Schizophrenia, Antipsychotics, Aripiprazole, Brexpiprazole
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- 31 Jan 2026 (actual)
- First posted
- 23 Dec 2021 (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.
MainRexult study aims to carefully evaluate a cohort of patients with schizophrenia and related disorder prescribed with the combination therapy with Abilify Maintena and Rexulti on its efficacy and tolerability in a real-life clinical setting.
Detailed description
Currently, there is no recommendation on next-step treatment strategy if the patients remain suffering from residual symptoms, have incomplete remission, or have acute exacerbation of schizophrenia whilst receiving aripiprazole long acting injection at its recommended (maximum) dose, except to switch to other second generation antipsychotics (SGA) or to clozapine if they are in their treatment-resistant course. Such practice may incur risks of full relapse and/or unnecessary side effects to the patients, in particularly to those already showed insufficient treatment response, intolerability to side effects, or non-adherence to other antipsychotics before. On the contrary, adding another SGAs to this special cohort appears to be rational. Especially, brexpiprazole might be an ideal choice for its serotonin-dopamine activity modulator property to achieve better symptom control, and at the same time retaining the benefits from the lower incidence of side effects than other SGAs.
Cases reports on combination therapy with aripiprazole (oral or LAI) with brexpiprazole had demonstrated initial favorable outcomes, albeit lacking empirical evidence from randomized controlled trial or longer term follow-up study. Therefore, the current MainRexult study aims to carefully evaluate a cohort of patients with schizophrenia and related disorders prescribed with the combination therapy with Abilify Maintena and Rexulti on its efficacy and tolerability in an non-interventional, naturalistic real-life clinical setting.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MainRexult Group | – | Drug: ARIPiprazole Injection [Abilify], Drug: BrexpiprazoleSubjects with schizophrenia and related disorders receiving Abilify Maintena (aripiprazole 1 monthly depot) together with Rexulti (Brexpiprazole) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Subjects are diagnosed with schizophrenia and related disorders who are receiving Abilify Maintena and Brexpiprazole as treatment.
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 to have Schizophrenia (DSM-5 or ICD-10 F20 [except F20.81], Schizotypal (Personality) Disorder (DSM-5 or ICD-10 F21), or Schizoaffective Disorder (DSM-5 or ICD-10 F25), (Persistent) Delusional Disorder (DSM-5 or ICD-10 F22), Schizophreniform Disorder (DSM-5 or ICD-10 F20.81), Brief Psychotic Disorder (DSM-5) or Acute and Transient Psychotic Disorder (ICD-10 F23)
- Is receiving the combination with Abilify Maintena and brexpiprazole as treatment ≤8 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 |
|---|---|---|
| ARIPiprazole Injection [Abilify]Also: Abilify Maintenasubject already receiving the combination of Abilify Maintena and Rexulti | Drug | MainRexult Group |
| BrexpiprazoleAlso: Rexultisubject already receiving the combination of Abilify Maintena and Rexulti | Drug | MainRexult Group |
Primary outcome
Change from baseline score of the Brief Psychiatric Rating Scale-24 at 3rd and 6th months
Time frame: 6 months
Measuring efficacy on positive and negative psychotic symptoms with a total score ranges from 24 (normal) to 168 (severe ill)
Change from baseline score of the Clinical Global Impression Scale at 3rd and 6th months
Time frame: 6 months
measuring efficacy on overall clinical improvement and severity of subjects with a score ranges from 0 (normal) to 18 (severely ill)
Change from baseline score of the Hamilton Anxiety Rating Scale at 3rd and 6th months
Time frame: 6 months
measuring anxiety symptoms of the subjects with a score ranges from 0 (not ill) to 56 (severe)
Change from basline score of the Hamilton Depression Rating Scale at 3rd and 6th months
Time frame: 6 months
measuring depressive symptoms of the subjects with a score ranges from 0 (normal) to 62 (very severe)
2 secondary outcomes
Change from basline score of the Simpson Angus Score at 3rd and 6th months
Time frame: 6 months
Change from baseline score of the Barnes Akathisia Rating Scale at 3rd and 6th months
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Albert KK Chung principal investigator
The University of Hong Kong
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 Schizophrenia and Related Disorders and Anxiety Depression, run by The University of Hong Kong 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: finished, as of the sponsor's last update on 27 Apr 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline score of the Brief Psychiatric Rating Scale-24 at 3rd and 6th months (time frame: 6 months). The study lists 4 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 27 Apr 2026.