Real-life Assessment of Abilify Maintena + Rexult in Schizophrenia (MainRexult)

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.

Study Overview

• Status: Recruiting
• Conditions: Anxiety Depression; Schizophrenia and Related Disorders
• Intervention / Treatment: Drug: ARIPiprazole Injection [Abilify]; Drug: Brexpiprazole

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 Type: Observational
• Enrollment (Estimated): 10

Contacts and Locations

• Study Contact: Name: Albert KK Chung, MBBS; Phone Number: 2255 4486; Email: Chungkka@hku.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong, 000000
    • Recruiting
    • Queen Mary Hospital
    • Contact: Albert KK Chung; Phone Number: 2255 3067; Email: chungkka@hku.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
MainRexult Group; Subjects with schizophrenia and related disorders receiving Abilify Maintena (aripiprazole 1 monthly depot) together with Rexulti (Brexpiprazole)	Drug: ARIPiprazole Injection [Abilify]; subject already receiving the combination of Abilify Maintena and Rexulti; Other Names: Abilify Maintena; Drug: Brexpiprazole; subject already receiving the combination of Abilify Maintena and Rexulti; Other Names: Rexulti

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	6 months

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Investigators: Principal Investigator: Albert KK Chung, The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): June 28, 2025

Study Registration Dates

• First Submitted: November 26, 2021
• First Submitted That Met QC Criteria: December 21, 2021
• First Posted (Actual): December 23, 2021

Study Record Updates

• Last Update Posted (Actual): July 5, 2023
• Last Update Submitted That Met QC Criteria: July 2, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Schizophrenia; Aripiprazole; Antipsychotics; Brexpiprazole
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Antidepressive Agents; Dopamine Agonists; Dopamine Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Aripiprazole; Brexpiprazole
• Other Study ID Numbers: UW-21-734

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No