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Completed

NCT Number: NCT05169268

Real-life Assessment of Abilify Maintena + Rexult in Schizophrenia

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Queen Mary Hospital

Hong Kong, 000000

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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 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

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)

Treatment and study plan

ARIPiprazole Injection [Abilify]

Drug

subject already receiving the combination of Abilify Maintena and Rexulti

Other names: Abilify Maintena

Brexpiprazole

Drug

subject already receiving the combination of Abilify Maintena and Rexulti

Other names: Rexulti

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

Secondary outcomes

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

    Time frame: 6 months

    for intolerability assessment on extra-pyramidal side effects of the subjects from 0 (not present) to 24 (most severe)

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

    Time frame: 6 months

    for intolerability assessment on akathisia of the subjects from 0 (not present) to 14 (severe)

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study 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

Acronym: MainRexult

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Dec 23, 2021
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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