Real-life Assessment of Abilify Maintena + Rexult in Schizophrenia

Anxiety Depression Clinical Trial

— MainRexult  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05169268
• Other study ID #: UW-21-734
• Status: Recruiting
• Start date: February 1, 2022
• Est. completion date: June 28, 2025

Study information

• Verified date: July 2023
• Source: The University of Hong Kong
• Contact: Albert KK Chung, MBBS
• Phone: 2255 4486
• Email: chungkka[@]hku.hk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: June 28, 2025
• Est. primary completion date: December 31, 2024
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Anxiety Depression
• Schizophrenia
• Schizophrenia and Related Disorders

Intervention

Drug:
• ARIPiprazole Injection [Abilify]
subject already receiving the combination of Abilify Maintena and Rexulti
• Brexpiprazole
subject already receiving the combination of Abilify Maintena and Rexulti

Locations

Country	Name	City	State
Hong Kong	Queen Mary Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline score of the Brief Psychiatric Rating Scale-24 at 3rd and 6th months	Measuring efficacy on positive and negative psychotic symptoms with a total score ranges from 24 (normal) to 168 (severe ill)	6 months
Primary	Change from baseline score of the Clinical Global Impression Scale at 3rd and 6th months	measuring efficacy on overall clinical improvement and severity of subjects with a score ranges from 0 (normal) to 18 (severely ill)	6 months
Primary	Change from baseline score of the Hamilton Anxiety Rating Scale at 3rd and 6th months	measuring anxiety symptoms of the subjects with a score ranges from 0 (not ill) to 56 (severe)	6 months
Primary	Change from basline score of the Hamilton Depression Rating Scale at 3rd and 6th months	measuring depressive symptoms of the subjects with a score ranges from 0 (normal) to 62 (very severe)	6 months
Secondary	Change from basline score of the Simpson Angus Score at 3rd and 6th months	for intolerability assessment on extra-pyramidal side effects of the subjects from 0 (not present) to 24 (most severe)	6 months
Secondary	Change from baseline score of the Barnes Akathisia Rating Scale at 3rd and 6th months	for intolerability assessment on akathisia of the subjects from 0 (not present) to 14 (severe)	6 months