Queen Mary Hospital
Hong Kong, 000000
NCT Number: NCT05169268
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.
Looking for future studies?
Notify Me18 year–65 year
All sexes
Observational
Hong Kong, 000000
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.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
subject already receiving the combination of Abilify Maintena and Rexulti
Other names: Abilify Maintena
subject already receiving the combination of Abilify Maintena and Rexulti
Other names: Rexulti
Time frame: 6 months
Measuring efficacy on positive and negative psychotic symptoms with a total score ranges from 24 (normal) to 168 (severe ill)
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)
Time frame: 6 months
measuring anxiety symptoms of the subjects with a score ranges from 0 (not ill) to 56 (severe)
Time frame: 6 months
measuring depressive symptoms of the subjects with a score ranges from 0 (normal) to 62 (very severe)
Time frame: 6 months
for intolerability assessment on extra-pyramidal side effects of the subjects from 0 (not present) to 24 (most severe)
Time frame: 6 months
for intolerability assessment on akathisia of the subjects from 0 (not present) to 14 (severe)
The University of Hong Kong
Other
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
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.
Published trials that share one or more normalized conditions with this study.
NCT07378150
Mental Disorders, Schizophrenia
Kütahya, Turkey (Türkiye)
View Trial DetailsNCT06175559
Behavior, Gamification
Shanghai, Shanghai Municipality, China
View Trial DetailsNCT06426134
Bipolar and Related Disorders, Depressive Episode
Amsterdam, North Holland, Netherlands
View Trial DetailsNCT03485417
Disease, Mental Disorders
Hong Kong
View Trial Details