European Long-acting Antipsychotics in Schizophrenia Trial-II
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Schizophrenia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Israel
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
Schizophrenia is a chronic psychiatric illness with a heterogeneous disease course, varying from periods of symptomatic remission to relapse. Relative to the wealth of scientific data on the course of schizophrenia during the two years following the first psychotic episode, the outcome of schizophrenia patients over the first decade of their illness has been studied to a lesser degree. In this follow-up cohort study the aim is to investigate the long-term outcome of schizophrenia patients who participated in the previously conducted EULAST-I clinical trial, in the first decade after being diagnosed.
Detailed description
At this point, given the heterogeneity of published studies, it remains unclear if depot medication can reduce relapse rates and improve clinical outcome when offered to all patients in need of continuation treatment with antipsychotics. Before anyone can conclude whether or not all schizophrenia patients could benefit from a switch to depot formulations, several questions remain to be answered. Is depot medication associated with better continuation rates and outcome? How are depot medications tolerated as compared to oral medication? In order to clarify these important issues this study aims to perform a large multi-center trial in which schizophrenia patients in need of continuous treatment who are randomized 1:1:1:1 to two different depot preparations or to two different oral medications; patients will be followed up for a total of 19 months.
The primary objective of this trial is to compare all cause discontinuation rates in patients with schizophrenia randomized to oral antipsychotic medications (i.e., aripiprazole or paliperidone) versus depot antipsychotic medications (i.e., paliperidone palmitate or aripiprazole depot) over an 18 month follow-up period.
Primary outcome measures
- To assess which baseline EULAST-I clinical trial baseline characteristics predict healthcare utilization (defined as number of days hospitalized) over a period of 3 - 10 years (since the EULAST-I clinical trial baseline visit). [Time frame: 3 - 10 years (since the EULAST-I clinical trial baseline visit).]
Secondary outcome measures (10)
- To provide insight into long-term social functioning as measured through the Personal and Social Performance (PSP) scale. [Time frame: 3 - 10 years (since the EULAST-I clinical trial baseline visit).]
- To provide insight into long-term sociodemographic outcome (living circumstances, education, marital status). [Time frame: 3 - 10 years (since the EULAST-I clinical trial baseline visit).]
- To provide insight in changes in neuropsychiatric diagnoses as measured through the Mini-International Neuropsychiatric Interview 7.0.2 (M.I.N.I. 7.0.2) since the EULAST-I clinical trial screening visit. [Time frame: 3 - 10 years (since the EULAST-I clinical trial baseline visit).]
- To provide insight in long-term outcome in quality of life as measured through the Euroqol quality of life scale (EQ-5D-5L). [Time frame: 3 - 10 years (since the EULAST-I clinical trial baseline visit).]
- To provide insight in long-term outcome in alcohol and drug use as well as smoking as measured through the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST). [Time frame: 3 - 10 years (since the EULAST-I clinical trial baseline visit).]
- To provide insight in long-term outcome of tardive dyskinesia as measured through the Abnormal and Involuntary Movement Scale (AIMS). [Time frame: 3 - 10 years (since the EULAST-I clinical trial baseline visit).]
- To provide insight in long-term outcome of extrapyramidal symptoms as measured through the St. Hans rating scale. [Time frame: 3 - 10 years (since the EULAST-I clinical trial baseline visit).]
- To provide insight in the use of antipsychotic medication and other medication since the previous EULAST-I clinical trial. [Time frame: 3 - 10 years (since the EULAST-I clinical trial baseline visit).]
- To provide insight into the reasons for hospitalizations since the baseline visit of the previous EULAST-I clinical trial. [Time frame: 3 - 10 years (since the EULAST-I clinical trial baseline visit).]
- To provide insight into the incidence of suicide attempts since the baseline visit of the previous EULAST-I clinical trial [Time frame: 3 - 10 years (since the EULAST-I clinical trial baseline visit).]
Eligibility criteria
Inclusion criteria
- Capable of providing written informed consent / have a legal representative to provide written informed consent. \*
- Having been randomized to one of the four treatment arms (aripiprazole oral, aripiprazole depot, paliperidone oral, paliperidone depot) in the 2014-002765-30 EULAST-I clinical trial or having participated in the EULAST-I naturalistic cohort study.
- Unless prohibited by local law (e.g. due to incarceration).
Exclusion Criteria: No exclusion criteria are applicable in this study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Israel · 1 center
- Tel Hashomer The Sheba Medical Center — Ramat Gan
Identifiers
NCT: NCT05165316 · 00-000