Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Lundbeck Canada Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aripiprazole Once-Monthly (AOM) | Drug | Dosage and frequency of AOM administration individualized for each study participant in accordance with investigators' clinical judgment. |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Francois Therrien, Pharm.D. | Contact | 15143323065 | francois.therrien@otsuka-ca.com |
| Name | Affiliation | Role |
|---|---|---|
| Francois Therrien, Pharm.D. | Otsuka Canada Pharmaceutical Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ottawa Hospital, Civic Campus | Recruiting | Ottawa | Ontario | K1Y 4E9 | Canada |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
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 |