SchizophreniaEULAST-IINCT05165316
European Long-acting Antipsychotics in Schizophrenia Trial-II
An observational study of Schizophrenia, run by Rene Kahn at 1 site in Israel.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia
- How many people
- 400 participants
- Where
- 1 siteIsrael
- Study dates
- 31 Dec 2021to Feb 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Conditions
- Schizophrenia
- Medical subject headings
- Schizophrenia
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 3 - 10 years (since the EULAST-I clinical trial baseline visit).
To provide insight into long-term sociodemographic outcome (living circumstances, education, marital status).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 3 - 10 years (since the EULAST-I clinical trial baseline visit).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2021
- Study start31 Dec 2021
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rene Kahn
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rene Kahn, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05165316
- Sponsor's protocol ID
- 00-000
- Acronym
- EULAST-II
- Status last verified
- Jan 2026
- First submitted
- 7 Dec 2021
- Last updated
- 23 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- European Long-acting Antipsychotics in Schizophrenia Trial-II
- ClinicalTrials.gov ID
- NCT05165316
- Acronym / sponsor ID
- EULAST-II / 00-000
- Conditions
- Schizophrenia
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Rene KahnUniversity, hospital or other
- Study start
- 31 Dec 2021 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 21 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
- Exclusion Criteria: No exclusion criteria are applicable in this study.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
10 secondary outcomes
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia, run by Rene Kahn at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.