European Long-acting Antipsychotics in Schizophrenia Trial-II

Schizophrenia Clinical Trial

— EULAST-II  

Official title:

European Long-acting Antipsychotics in Schizophrenia Trial-II

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05165316
• Other study ID #: 00-000
• Status: Not yet recruiting
• Start date: December 2021
• Est. completion date: August 2025

Study information

• Verified date: December 2021
• Source: UMC Utrecht
• Contact: Lyliana Nasib, MSc
• Phone: 0633719126
• Email: lnasib[@]umcutrecht.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 we aim 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: August 2025
• Est. primary completion date: August 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Schizophrenia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rene Kahn

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).
Secondary	To provide insight into long-term sociodemographic outcome (living circumstances, education, marital status).		3 - 10 years (since the EULAST-I clinical trial baseline visit).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).