A European Non-Interventional Study (NIS) in Patients with Schizophrenia Treated with Antipsychotic Long-Acting Injections (LAIs)

Conditions: F20
Schizophrenia

Registration Number: DRKS00005466

Lead Sponsor: H. Lundbeck A/S

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 654

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

• 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

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cross-sectional part: <br>The primary objective is to characterize current real-life practice patterns for the use of LAIs by describing:<br>- Provider and site characteristics of psychiatrists prescribing LAIs (once at start of study)<br>- Socio-demographics and clinical characteristics of patients with schizophrenia receiving LAIs (at baseline visit).<br>Longitudinal part:<br>- To evaluate the subjective well-being in patients with schizophrenia, initiating a treatment with an antipsychotic LAI (months 3, 6, 12 and 18)<br>

Secondary Outcome Measures