Recruiting

Aripiprazole

Sponsor:

Otsuka Canada Pharmaceutical Inc.

Code:

NCT04907279

Conditions

Schizophrenia

Schizo Affective Disorder

Bipolar I Disorder

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Not accepted

Interventions

Aripiprazole Once-Monthly (AOM)

Study Details

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

Study ID

NCT04907279

Start date

Nov 1, 2021

Status verified date

Apr, 2022

Completion date

Jun, 2023

Anticipated

Primary completion date

Dec, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Not accepted

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 Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Interventions

Aripiprazole Once-Monthly (AOM)

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

Primary outcome measure

  • Average dose of Aripiprazole Once Monthly (AOM) [ Time Frame: Through study completion, an average of 3 weeks ]

Central Contacts and Locations

Central contacts

Locations

Ottawa Hospital, Civic Campus

Recruiting

Ottawa, Ontario, Canada, K1Y 4E9

More Information

Sponsor

Otsuka Canada Pharmaceutical Inc.

Last update posted

Apr 20, 2022

Last verified

Apr, 2022

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Otsuka Canada Pharmaceutical Inc. on 2022-04-20.