Real-life Assessment of Abilify Maintena + Rexult in Schizophrenia

NCT05169268 | Completed FDA Drug

• 1 other identifier: UW-21-734
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Schizophrenia and Related Disorders; Anxiety Depression

Keywords

Schizophrenia; Antipsychotics; Aripiprazole; Brexpiprazole

Outcome Measures

Primary Outcomes (4)

• 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)

  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)

  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)

  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)

  6 months

Secondary Outcomes (2)

• Change from basline score of the Simpson Angus Score at 3rd and 6th months

  6 months

• Change from baseline score of the Barnes Akathisia Rating Scale at 3rd and 6th months

  6 months

Study Arms (1)

MainRexult Group

Subjects with schizophrenia and related disorders receiving Abilify Maintena (aripiprazole 1 monthly depot) together with Rexulti (Brexpiprazole)

Drug: ARIPiprazole Injection [Abilify]; Drug: Brexpiprazole

Interventions

Brexpiprazole DRUG

subject already receiving the combination of Abilify Maintena and Rexulti

Also known as: Rexulti

MainRexult Group

ARIPiprazole Injection [Abilify] DRUG

subject already receiving the combination of Abilify Maintena and Rexulti

Also known as: Abilify Maintena

MainRexult Group

Eligibility Criteria

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

Study Population

Subjects are diagnosed with schizophrenia and related disorders who are receiving Abilify Maintena and Brexpiprazole as treatment.

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 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

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

• The University of Hong Kong: lead

Study Sites (1)

Queen Mary Hospital

Hong Kong, 000000, Hong Kong

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Aripiprazole; brexpiprazole

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Albert KK Chung

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2021
• First Posted: December 23, 2021
• Study Start: February 1, 2022
• Primary Completion: January 31, 2026
• Study Completion: January 31, 2026
• Last Updated: April 27, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)