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

The University of Hong Kong (HKU)

Status

Enrolling

Conditions

Anxiety Depression

Schizophrenia and Related Disorders

Treatments

Drug: Brexpiprazole

Drug: ARIPiprazole Injection [Abilify]

Study type

Observational

Funder types

Other

Identifiers

NCT05169268

UW-21-734

Details and patient eligibility

About

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.

Full 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.

Enrollment

10 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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)