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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Schizophrenia; Schizo Affective Disorder; Bipolar I Disorder
• Intervention / Treatment: Drug: Aripiprazole Once-Monthly (AOM)

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.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Francois Therrien, Pharm.D.; Phone Number: 15143323065; Email: francois.therrien@otsuka-ca.com

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1Y 4E9
      • Recruiting
      • Ottawa Hospital, Civic Campus
      • Contact: Ottawa Hospital C Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with a primary diagnosis of schizophrenia, schizoaffective disorder or bipolar I disorder requiring hospitalization and for whom, according to the clinical judgment of the treating clinician, Aripiprazole Once-Monthly is indicated.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Ecologic or Community
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of hospital stay	Number of days between initiation of AOM and termination of hospital stay	Through study completion, an average of 3 weeks
Clinical Global Impression-Improvement (CGI-I) score	Mean change in clinical symptom severity from baseline	Through study completion, an average of 3 weeks
Global Impression-Severity of Illness (CGI-S) score	Mean global severity of clinical symptoms	Through study completion, an average of 3 weeks
Personal and Social Performance (PSP) score	Mean psycho-social functioning score	Through study completion, an average of 3 weeks
Medication Satisfaction Questionnaire (MSQ) score	Mean score/level of satisfaction with current treatment administered	Through study completion, an average of 3 weeks

Collaborators and Investigators

• Sponsor: Otsuka Canada Pharmaceutical Inc.
• Collaborators: Lundbeck Canada Inc.
• Investigators: Study Director: Francois Therrien, Pharm.D., Otsuka Canada Pharmaceutical Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: May 21, 2021
• First Submitted That Met QC Criteria: May 25, 2021
• First Posted (Actual): May 28, 2021

Study Record Updates

• Last Update Posted (Actual): April 20, 2022
• Last Update Submitted That Met QC Criteria: April 19, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Schizophrenia; Schizoaffective Disorder; Aripiprazole; Bipolar I Disorder; Long-Acting Injectable
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Disease; Psychotic Disorders; Mood Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Antidepressive Agents; Dopamine Agonists; Dopamine Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Aripiprazole
• Other Study ID Numbers: 031-203-00468

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No