Aripiprazole Once-Monthly in Hospitalized Patients (INITIATE)

Schizophrenia Clinical Trial

— INITIATE  

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 Details — Status: Recruiting

Administrative data

• NCT number: NCT04907279
• Other study ID #: 031-203-00468
• Status: Recruiting
• Start date: November 1, 2021
• Est. completion date: June 2023

Study information

• Verified date: April 2022
• Source: Otsuka Canada Pharmaceutical Inc.
• Contact: Francois Therrien, Pharm.D.
• Phone: 15143323065
• Email: francois.therrien[@]otsuka-ca.com
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

1. The patient is between the age of majority (18 or 19 depending on the province) and 64 years of age inclusively;

2. The patient is currently hospitalized for the treatment of schizophrenia, schizoaffective disorder or BP1;

3. The patient is diagnosed with schizophrenia, schizoaffective disorder, or BP1 as defined by DSM-5 criteria;

4. The treating physician reached the decision to treat the patient with AOM prior to and independently of soliciting the patient to participate in the study;

5. The patient initiated treatment with AOM prior to enrolment and in accordance with routine clinical practice, including the assessment of potential risks associated with the medication (e.g. suicidality);

6. The patient or legal guardian (if applicable and when allowable by law) signed an informed consent indicating the understanding of the study and allowing the use of their anonymous data for the purposes of the study; and

7. The patient and caregiver(s) (if applicable) is/are fluent in English or French, in order to be able to complete the patient-administered questionnaires.

Exclusion Criteria:

1. As per clinical judgement of the treating physician, the patient is diagnosed with treatment-resistant schizophrenia;

2. The patient does not comprehend or refuses to sign the informed consent;

3. The patient is unlikely to comply with study procedures according to the clinical judgment of the investigator;

4. The patient has any contraindications to the use of AOM as specified in the Canadian Product Monograph;

5. The patient is a member of the study personnel or of their immediate families or is a subordinate (or immediate family member of a subordinate) to any of the study personnel;

6. The patient has previously been enrolled in this study.

Related Conditions & MeSH terms

• Bipolar I Disorder
• Disease
• Mood Disorders
• Psychotic Disorders
• Schizo Affective Disorder
• Schizophrenia

Intervention

Drug:
• Aripiprazole Once-Monthly (AOM)
Dosage and frequency of AOM administration individualized for each study participant in accordance with investigators' clinical judgment.

Locations

Country	Name	City	State
Canada	Ottawa Hospital, Civic Campus	Ottawa	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Otsuka Canada Pharmaceutical Inc.	Lundbeck Canada Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average dose of Aripiprazole Once Monthly (AOM)	The average total dose of AOM administered (number of mg and frequency of administration) during the hospitalization period will be evaluated	Through study completion, an average of 3 weeks
Secondary	Duration of hospital stay	Number of days between initiation of AOM and termination of hospital stay	Through study completion, an average of 3 weeks
Secondary	Clinical Global Impression-Improvement (CGI-I) score	Mean change in clinical symptom severity from baseline	Through study completion, an average of 3 weeks
Secondary	Global Impression-Severity of Illness (CGI-S) score	Mean global severity of clinical symptoms	Through study completion, an average of 3 weeks
Secondary	Personal and Social Performance (PSP) score	Mean psycho-social functioning score	Through study completion, an average of 3 weeks
Secondary	Medication Satisfaction Questionnaire (MSQ) score	Mean score/level of satisfaction with current treatment administered	Through study completion, an average of 3 weeks