NCT05169268

Real-life Assessment of Abilify Maintena + Rexult in Schizophrenia

Real-life Assessment of Aripiprazole Long-acting Injection (Abilify Maintena) Combined With Brexpiprazole (Rexulti) in Schizophrenia: a Naturalistic Non-interventional Prospective Follow-up Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 10 (estimated)
• Sponsor: The University of Hong Kong · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: —

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.

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.

Conditions

• Schizophrenia and Related Disorders
• Anxiety Depression

Interventions

Type	Name	Description
DRUG	ARIPiprazole Injection [Abilify]	subject already receiving the combination of Abilify Maintena and Rexulti
DRUG	Brexpiprazole	subject already receiving the combination of Abilify Maintena and Rexulti

Timeline

• Start date: 2022-02-01
• Primary completion: 2025-10-30
• Completion: 2026-01-31
• First posted: 2021-12-23
• Last updated: 2025-07-09

Locations

1 site across 1 country: Hong Kong

Regulatory

• FDA-regulated drug study