European Long-acting Antipsychotics in Schizophrenia Trial-II

NCT05165316 | Enrolling By Invitation

• 1 other identifier: 00-000
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• 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 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 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 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).

• 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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of patients with schizophrenia who participated in the previously conducted EULAST-I clinical trial. All patients who were randomized (to either aripiprazole oral, aripiprazole depot, paliperidone oral, paliperidone depot) or who participated in the naturalistic follow-up part of the EULAST-I clinical trial will be invited to participate in the current long-term follow-up cohort study (EULAST-II); this includes patients who dropped-out after randomization, patients who met All Cause Discontinuation (ACD) criteria and patients who completed the previous EULAST-I clinical trial. Patients will be over 18 years of age. The current long-term follow-up visit will take place at least three years after each patient's last visit as conducted within the EULAST-I clinical trial or the naturalistic follow-up study.

You may qualify if:

• 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).

Sponsors & Collaborators

• Rene Kahn: lead

Study Sites (1)

Tel Hashomer The Sheba Medical Center

Ramat Gan, Israel

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Psychiatry Department

Study Record Dates

• First Submitted: December 7, 2021
• First Posted: December 21, 2021
• Study Start: December 31, 2021
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)