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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT03005769 |
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Date of registration:
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21/12/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Demographic and Clinical Predictors of Persistence in Patients Treated With Aripiprazole Once-monthly in Italy
DOMINO |
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Scientific title:
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Demographic and Clinical Predictors of Persistence in Patients Treated With Aripiprazole Once-monthly in the Italian Clinical Practice: a Retrospective Cohort, Observational Study |
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Date of first enrolment:
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December 2016 |
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Target sample size:
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262 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03005769 |
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Study type:
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Observational |
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Study design:
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Phase:
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N/A
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Countries of recruitment
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Italy
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Contacts
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Name:
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Medical Department |
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Address:
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Telephone:
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Email:
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Affiliation:
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Otsuka Europe |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Adult patients (age = 18 years at the time of aripiprazole once-monthly initiation)
2. Male or female
3. Diagnosis of schizophrenia according to Diagnostic and Statistical Manual of Mental
Disorders, Fifth edition (DSM-5), available at start of aripiprazole once-monthly
treatment, and confirmed by the current investigator
4. Aripiprazole once-monthly initiation (at least 1 injection) according to the clinical
practice, at least 6 months before the inclusion and on June 1st 2015 or at a later
date (index date)
5. Aripiprazole once-monthly was the main antipsychotic at the time of treatment
initiation
6. Willingness to participate in the study; subjects must give their written consent to
participate
Exclusion Criteria:
1. The patient has a psychiatric disorder other than schizophrenia as primary diagnosis
2. Participation in a clinical trial during the retrospective follow-up period.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Schizophrenia
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Primary Outcome(s)
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Persistence (number of days) with aripiprazole once-monthly treatment
[Time Frame: During the first 6 months after aripiprazole once-monthly initiation.]
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Secondary Outcome(s)
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Characterization of the psychotic spectrum of the participating subjects according to Structured Clinical Interview for the Psychotic Spectrum (SCI-PSY) questionnaire.
[Time Frame: Only one time: at the end of each patient's follow-up, at least 6 months after aripiprazole once-monthly initiation]
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Description of aripiprazole once-monthly discontinuations and temporary interruptions and their reasons.
[Time Frame: Through study completion, at least 6 months.]
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Description of health resource use related to schizophrenia (hospitalisations, outpatient visits, procedures, schizophrenia drugs)
[Time Frame: Through study completion, at least 6 months.]
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Characterization of the schizophrenia dimensions of the participating subjects according to the Lifetime Dimensions for Psychosis Scale (LDPS) questionnaire.
[Time Frame: Only one time: at the end of each patient's follow-up, at least 6 months after aripiprazole once-monthly initiation]
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Mean Clinical Global Impressions - Severity scale (CGI-S) changes
[Time Frame: Through study completion, at least 6 months.]
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Secondary ID(s)
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031-306-00108
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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