F20
Conditions
Interventions
Group 1: Cross-sectional part: All patients (prevalent and incident users of LAIs ( (long acting injections)) complete four questionnaires at baseline visit: Birchwood Insight Scale, DAI-10 (drug atti
Sponsors
H. Lundbeck A/S
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • The patient is an in- or out-patient • The patient is aged of 18 years or older • The patient has a diagnosis of schizophrenia according to ICD-10 criteria • The patient is receiving a typical or atypical antipsychotic LAI (Only patients initiating an antipsychotic LAI at study entry will be proposed to participate in the longitudinal part of the study) • The patient has signed the informed consent
Exclusion criteria
Exclusion criteria: • The patient is pregnant or breastfeeding • The patient has acute serious or unstable medical condition (other than schizophrenia) that would compromise patient study participation according to physician’s judgment • The patient attempted to commit suicide in the past 30 days • The patient is not able to read or consent • 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 • The patient is currently participating to an interventional randomised clinical trial (or intend to participate during the course of this study) • The patient is, in the physician’s opinion, unlikely to comply with the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cross-sectional part: The primary objective is to characterize current real-life practice patterns for the use of LAIs by describing: - Provider and site characteristics of psychiatrists prescribing LAIs (once at start of study) - Socio-demographics and clinical characteristics of patients with schizophrenia receiving LAIs (at baseline visit). Longitudinal part: - To evaluate the subjective well-being in patients with schizophrenia, initiating a treatment with an antipsychotic LAI (months 3, 6, 12 and 18) | — |
Secondary
| Measure | Time frame |
|---|---|
| Cross-sectional part (baseline visit): - To identify subgroups of patients (clusters of antipsychotic LAIs users) characterized by specific sets of attributes - To describe and compare psychiatrists' opinion on antipsychotic LAIs and their prescriptions to patients with schizophrenia. Longitudinal part (baseline vist and follow up visits months 3, 6, 12 and 18): - To examine the association between the severity of disease, insight, patient’s attitude to treatment and adherence to medication, side-effects, subjective well-being and functioning and how this relationship change over time - To describe the time to all cause discontinuation of antipsychotic LAIs and other patterns of use of antipsychotics LAIs (eg dose, polypharmacy etc), as well as reasons for discontinuations - To describe hospitalisation patterns and healthcare utilization and compare healthcare utilization in 12 months before the initiation of antipsychotic LAIs with healthcare utilization in 12 months after the initiation of antipsychotic LAIs. | — |
Countries
Austria, France, Germany, Spain, Sweden, United Kingdom
Contacts
Public ContactFrancesca Cellauro
Outcome Europe Sàrl
Outcome results
None listed