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Demographic and Clinical Predictors of Persistence in Patients Treated With Aripiprazole Once-monthly in Italy (DOMINO)

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Otsuka

Status

Completed

Conditions

Schizophrenia

Study type

Observational

Funder types

Industry

Identifiers

NCT03005769
031-306-00108

Details and patient eligibility

About

This is an observational, retrospective, non-interventional study that will include schizophrenic patients who were initiated with aripiprazole once-monthly as per normal clinical practice at least 6 months before the data collection starts (inclusion visit), and is designed to evaluate demographic and clinical predictors of persistence with this treatment.

Data from each patient will be collected after informed consent is signed (inclusion visit), and will include retrospective information from the start of aripiprazole once-monthly treatment initiation (index date) until the follow-up/inclusion visit (minimum of 6 months after the index date). Data will be retrospectively collected from all visits occurring as per clinical practice (usually once monthly).

Enrollment

262 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial contacts and locations

20

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Data sourced from clinicaltrials.gov

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