Status:
UNKNOWN
Aripiprazole Once-Monthly in Hospitalized Patients (INITIATE)
Lead Sponsor:
Otsuka Canada Pharmaceutical Inc.
Collaborating Sponsors:
Lundbeck Canada Inc.
Conditions:
Schizophrenia
Schizo Affective Disorder
Eligibility:
All Genders
18-64 years
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 effectivene...
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 a...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
November 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2023
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04907279
Start Date
November 1 2021
End Date
June 1 2023
Last Update
April 20 2022
Active Locations (1)
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1
Ottawa Hospital, Civic Campus
Ottawa, Ontario, Canada, K1Y 4E9