Aripiprazole Once-Monthly in Hospitalized Patients (INITIATE)

NCT04907279 | Unknown

• 1 other identifier: 031-203-00468
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Schizophrenia; Schizo Affective Disorder; Bipolar I Disorder

Keywords

Aripiprazole; Long-Acting Injectable; Schizophrenia; Schizoaffective Disorder; Bipolar I Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Duration of hospital stay

  Through study completion, an average of 3 weeks

• Clinical Global Impression-Improvement (CGI-I) score

  Through study completion, an average of 3 weeks

• Global Impression-Severity of Illness (CGI-S) score

  Through study completion, an average of 3 weeks

• Personal and Social Performance (PSP) score

  Through study completion, an average of 3 weeks

• Medication Satisfaction Questionnaire (MSQ) score

  Through study completion, an average of 3 weeks

Interventions

Aripiprazole Once-Monthly (AOM) DRUG

Dosage and frequency of AOM administration individualized for each study participant in accordance with investigators' clinical judgment.

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• The patient is between the age of majority (18 or 19 depending on the province) and 64 years of age inclusively;
• The patient is currently hospitalized for the treatment of schizophrenia, schizoaffective disorder or BP1;
• The patient is diagnosed with schizophrenia, schizoaffective disorder, or BP1 as defined by DSM-5 criteria;
• 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;
• 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);
• 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
• 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.

You may not qualify if:

• As per clinical judgement of the treating physician, the patient is diagnosed with treatment-resistant schizophrenia;
• The patient does not comprehend or refuses to sign the informed consent;
• The patient is unlikely to comply with study procedures according to the clinical judgment of the investigator;
• The patient has any contraindications to the use of AOM as specified in the Canadian Product Monograph;
• 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;
• The patient has previously been enrolled in this study.

Sponsors & Collaborators

• Otsuka Canada Pharmaceutical Inc.: lead
• Lundbeck Canada Inc.: collaborator

Study Sites (1)

Ottawa Hospital, Civic Campus

Ottawa, Ontario, K1Y 4E9, Canada

RECRUITING

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Francois Therrien, Pharm.D.

  Otsuka Canada Pharmaceutical Inc.

  STUDY DIRECTOR

Central Study Contacts

Francois Therrien, Pharm.D.

CONTACT

15143323065; francois.therrien@otsuka-ca.com

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2021
• First Posted: May 28, 2021
• Study Start: November 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: June 1, 2023
• Last Updated: April 20, 2022

Record last verified: 2022-04

Locations

CA (1)