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Aripiprazole Once-Monthly in Hospitalized Patients (INITIATE) — INITIATE  

Schizophrenia Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04907279
Study type Observational
Source Otsuka Canada Pharmaceutical Inc.
Contact Francois Therrien, Pharm.D.
Phone 15143323065
Email francois.therrien@otsuka-ca.com
Status Recruiting
Phase
Start date November 1, 2021
Completion date June 2023
View Details
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