European Long-acting Antipsychotics in Schizophrenia Trial-II

• Conditions: Schizophrenia

• Registration Number: NCT05165316
• Lead Sponsor: Rene Kahn

Brief Summary

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.

Study Timeline

• Study First Submitted: 2021-12-07
• Study First Submitted QC: 2021-12-07
• Study First Posted: 2021-12-21
• Study Start: 2021-12-31
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-26
• Last Update Posted: 2024-06-28
• Primary Completion: 2025-08
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

1. Capable of providing written informed consent / have a legal representative to provide written informed consent. *

2. 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).	3 - 10 years (since the EULAST-I clinical trial baseline visit).

Secondary Outcome Measures

Name	Time	Method
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).	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.	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.	3 - 10 years (since the EULAST-I clinical trial baseline visit).
To provide insight into long-term social functioning as measured through the Personal and Social Performance (PSP) scale.	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.	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	3 - 10 years (since the EULAST-I clinical trial baseline visit).
To provide insight into long-term sociodemographic outcome (living circumstances, education, marital status).	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).	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.	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).	3 - 10 years (since the EULAST-I clinical trial baseline visit).

Trial Locations

Locations (1)

Tel Hashomer The Sheba Medical Center; 🇮🇱 Ramat Gan, Israel