SchizophreniaINITIATENCT04907279
Aripiprazole Once-Monthly in Hospitalized Patients (INITIATE)
An observational study of Schizophrenia and Schizo Affective Disorder, run by Otsuka Canada Pharmaceutical Inc. at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Schizophrenia, Schizo Affective Disorder, Bipolar I Disorder
- What is being tested?
- Aripiprazole Once-Monthly (AOM)
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2021to Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Ottawa Hospital, Civic Campus
Ottawa, Ontario, K1Y 4E9
Ottawa Hospital C Campus
About this study
Official title: A Canadian Non-interventional Study of Aripiprazole Once-Monthly (AOM) Administration in Hospitalized Patients With Schizophrenia, Schizoaffective Disorder and Bipolar I Disorder
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.
Read the 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 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.
- Conditions
- Schizophrenia, Schizo Affective Disorder, Bipolar I Disorder
- Being tested
- Aripiprazole Once-Monthly (AOM)
- Keywords
- Aripiprazole, Long-Acting Injectable, Schizophrenia, Schizoaffective Disorder, Bipolar I Disorder
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aripiprazole Once-Monthly (AOM)Drug
Dosage and frequency of AOM administration individualized for each study participant in accordance with investigators' clinical judgment.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through study completion, an average of 3 weeks
Secondary outcomes (5)
Duration of hospital stay
Number of days between initiation of AOM and termination of hospital stay
Measured: Through study completion, an average of 3 weeks
Clinical Global Impression-Improvement (CGI-I) score
Mean change in clinical symptom severity from baseline
Measured: Through study completion, an average of 3 weeks
Global Impression-Severity of Illness (CGI-S) score
Mean global severity of clinical symptoms
Measured: Through study completion, an average of 3 weeks
Personal and Social Performance (PSP) score
Mean psycho-social functioning score
Measured: Through study completion, an average of 3 weeks
Medication Satisfaction Questionnaire (MSQ) score
Mean score/level of satisfaction with current treatment administered
Measured: Through study completion, an average of 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2021
- Study start1 Nov 2021
- Primary completionDec 2022 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Otsuka Canada Pharmaceutical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Lundbeck Canada Inc.
- Responsible party
- Sponsor
- Investigators
- Francois Therrien, Pharm.D., Study director, Otsuka Canada Pharmaceutical Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04907279
- Sponsor's protocol ID
- 031-203-00468
- Acronym
- INITIATE
- Status last verified
- Apr 2022
- First submitted
- 21 May 2021
- Last updated
- 20 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Canadian Non-interventional Study of Aripiprazole Once-Monthly (AOM) Administration in Hospitalized Patients With Schizophrenia, Schizoaffective Disorder and Bipolar I Disorder
- ClinicalTrials.gov ID
- NCT04907279
- Acronym / sponsor ID
- INITIATE / 031-203-00468
- Conditions
- Schizophrenia, Schizo Affective Disorder, Bipolar I Disorder
- Keywords
- Aripiprazole, Long-Acting Injectable, Schizophrenia, Schizoaffective Disorder, Bipolar I Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Otsuka Canada Pharmaceutical Inc.Industry (pharma, biotech, devices)
- Collaborators
- Lundbeck Canada Inc.
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 28 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (7 listed)
- 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);
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aripiprazole Once-Monthly (AOM)Dosage and frequency of AOM administration individualized for each study participant in accordance with investigators' clinical judgment. | Drug | – |
Primary outcome
Average dose of Aripiprazole Once Monthly (AOM)
Time frame: Through study completion, an average of 3 weeks
The average total dose of AOM administered (number of mg and frequency of administration) during the hospitalization period will be evaluated
5 secondary outcomes
Duration of hospital stay
Time frame: Through study completion, an average of 3 weeks
Clinical Global Impression-Improvement (CGI-I) score
Time frame: Through study completion, an average of 3 weeks
Global Impression-Severity of Illness (CGI-S) score
Time frame: Through study completion, an average of 3 weeks
Personal and Social Performance (PSP) score
Time frame: Through study completion, an average of 3 weeks
Medication Satisfaction Questionnaire (MSQ) score
Time frame: Through study completion, an average of 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francois Therrien, Pharm.D. study director
Otsuka Canada Pharmaceutical Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia and Schizo Affective Disorder, run by Otsuka Canada Pharmaceutical Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Francois Therrien, Pharm.D. (15143323065, francois.therrien@otsuka-ca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average dose of Aripiprazole Once Monthly (AOM) (time frame: Through study completion, an average of 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2022.