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

Sponsor

The University of Hong Kong (Other)

Overall Status

Recruiting

CT.gov ID

NCT05169268

Collaborator

(none)

Enrollment

Location

40.8

Anticipated Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia and Related Disorders Anxiety Depression	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 Design

Study Type:

Observational

Anticipated Enrollment :

10 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

Feb 1, 2022

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Jun 28, 2025

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Change from baseline score of the Brief Psychiatric Rating Scale-24 at 3rd and 6th months [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 [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 [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 [6 months]
measuring depressive symptoms of the subjects with a score ranges from 0 (normal) to 62 (very severe)

Secondary Outcome Measures

Change from basline score of the Simpson Angus Score at 3rd and 6th months [6 months]
for intolerability assessment on extra-pyramidal side effects of the subjects from 0 (not present) to 24 (most severe)
Change from baseline score of the Barnes Akathisia Rating Scale at 3rd and 6th months [6 months]
for intolerability assessment on akathisia of the subjects from 0 (not present) to 14 (severe)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

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)