Clinical trial NCT05169268: Real-life Assessment of Abilify Maintena + Rexult in Schizophrenia
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Schizophrenia and Related Disorders
Anxiety Depression
Keywords: Schizophrenia
Antipsychotics
Aripiprazole
Brexpiprazole
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2021-12-23
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects are diagnosed with schizophrenia and related disorders who are receiving Abilify Maintena and Brexpiprazole as treatment.

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change from baseline score of the Brief Psychiatric Rating Scale-24 at 3rd and 6th months
timeFrame: 6 months
measure: Change from baseline score of the Clinical Global Impression Scale at 3rd and 6th months
timeFrame: 6 months
measure: Change from baseline score of the Hamilton Anxiety Rating Scale at 3rd and 6th months
timeFrame: 6 months
measure: Change from basline score of the Hamilton Depression Rating Scale at 3rd and 6th months
timeFrame: 6 months
Secondary outcomes:
measure: Change from basline score of the Simpson Angus Score at 3rd and 6th months
timeFrame: 6 months
measure: Change from baseline score of the Barnes Akathisia Rating Scale at 3rd and 6th months
timeFrame: 6 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
Study officials:
affiliation: The University of Hong Kong
name: Albert KK Chung
role: PRINCIPAL_INVESTIGATOR
References: