Aripiprazole Once-Monthly in Hospitalized Patients (INITIATE)
NCT04907279 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 200
Last updated 2022-04-20
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
Interventions
- DRUG
-
Aripiprazole Once-Monthly (AOM)
Dosage and frequency of AOM administration individualized for each study participant in accordance with investigators' clinical judgment.
Sponsors & Collaborators
-
Lundbeck Canada Inc.
collaborator INDUSTRY -
Otsuka Canada Pharmaceutical Inc.
lead INDUSTRY
Principal Investigators
-
Francois Therrien, Pharm.D. · Otsuka Canada Pharmaceutical Inc.
Eligibility
- Min Age
- 18 Years
- Max Age
- 64 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-11-01
- Primary Completion
- 2022-12-31
- Completion
- 2023-06-30
Countries
- Canada
Study Locations
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