NCT04907279

Aripiprazole Once-Monthly in Hospitalized Patients (INITIATE)

A Canadian Non-interventional Study of Aripiprazole Once-Monthly (AOM) Administration in Hospitalized Patients With Schizophrenia, Schizoaffective Disorder and Bipolar I Disorder

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Otsuka Canada Pharmaceutical Inc. · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

To characterize the real-life clinical use of AOM in a hospitalized patient population with schizophrenia, schizoaffective disorder or BP1 requiring LAI therapy and evaluate its short-term effectiveness associated with its clinical use in the proposed patient population, including time to discharge, efficacy, safety, tolerability, and patients' satisfaction.

Detailed description

This is a non-interventional, Canadian, prospective multi-site study in schizophrenia, schizoaffective disorder and BP1 among in-patients treated with AOM at the discretion of the treating physician and followed for the duration of their hospital stay. With the objective of characterizing the real-life, in-patient clinical uses of AOM, this study will not impose any treatments outside of what is recommended by the attending physician. As such, only patients admitted into hospital and prescribed AOM as a part of their physician's treatment recommendation will be included in this study. Study assessments and administration of questionnaires will be limited to baseline measurements occurring within the first 72 hours of AOM administration and at the end of study participation. All patients will be treated with AOM at the dose that is as per the treating physician's judgment. The decision to treat the patient with AOM must be reached independently and in advance of recruitment in the study.

Conditions

• Schizophrenia
• Schizo Affective Disorder
• Bipolar I Disorder

Interventions

Type	Name	Description
DRUG	Aripiprazole Once-Monthly (AOM)	Dosage and frequency of AOM administration individualized for each study participant in accordance with investigators' clinical judgment.

Timeline

• Start date: 2021-11-01
• Primary completion: 2022-12-01
• Completion: 2023-06-01
• First posted: 2021-05-28
• Last updated: 2022-04-20

Locations

1 site across 1 country: Canada