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European Long-acting Antipsychotics in Schizophrenia Trial (EULAST)

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Aripiprazole
Aripiprazole depot
Paliperidone
Paliperidone palmitate
Sponsored by
UMC Utrecht
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring depot, oral, antipsychotics, paliperidone, aripiprazole

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Diagnosis of schizophrenia as defined by DSM-IV-R (Diagnostic and Statistical Manual) as determined by the M.I.N.I.plus
  2. Age 18 or older.
  3. 3. The first psychosis occurred at least 6 months and no more than 7 years ago.*
  4. If patients are using an antipsychotic drug, a medication switch is currently under consideration.
  5. Capable of providing written informed consent

    • Time of first psychosis is defined as the first contact with a health care professional in relation to psychotic symptoms.

Exclusion Criteria:

  1. Intolerance / hypersensitivity to both* of the drugs (including active substances, metabolites and excipients) in this study including oral paliperidone and aripiprazole and/or hypersensitivity to risperidone.
  2. Pregnancy or lactation.
  3. Patients who are currently using clozapine.
  4. Patients who do not fully comprehend the purpose or are not competent to make a rational decision whether or not to participate.
  5. Patients with a documented history of intolerance to both* of the study medications and/or a documented history of non-response to a treatment with both* study drugs of at least 6 weeks within the registered dose range.7. Patients who have been treated with an investigational drug within 30 days prior to screening.

8. Simultaneous participation in another intervention study (neither medication or psychosocial intervention).

* If intolerance/hypersensitivity or non-response in the past to one of the compounds is documented, the patient can still participate; however, randomization will take place by blocking that specific compound. That is, the patient will be randomized on either the oral or the depot arm of the other compound. This procedure of blocking one compound is also accepted for patients who have experienced too many side effects to one of the compounds in the past, as documented in the patient's medical record. The decision to block that specific compound for randomization in these cases is up to the discretion of the treating physician who will carefully balance this decision and clearly document it in the medical record.

Sites / Locations

  • Department of Biological Psychiatry, Innsbruck University Clinics
  • Psychosoziale Dienste
  • ZNA, department of Psychiatry, locatie Stuivenberg
  • Psychiatrisch Ziekenhuis Duffel
  • University Hospital of Neurology and Psychiatry 'St. Naum' 1
  • Psychiatrická klinika LF UK
  • Dr. Ustohal
  • Dr. Mohr
  • Center for Neuropsychiatric Research
  • Klinik und Poliklinik für Psychiatrie und Psychotherapie der Heinrich-Heine-Universität
  • Technische Universität München (TUM
  • Klinik für Psychiatrie, Psychotherapie und Psychosomatik der Martin-Luther-Universität
  • Department of Psychiatry and Psychotherapy
  • National and Kapodistrian University of Athens Medical School, Eginition Hospital
  • Dr. Csekey
  • Department of Psychiatry and Psychotherapy, Semmelweis University
  • Abravanel Mental Health Center
  • Be'er-Ness Mental Health Center
  • The Jerusalem Mental Health Center
  • Lev-Hasharon Medical Center for Mental Health
  • Geha Medical Health Center
  • The Chaim Sheba Medical Center
  • Department of Psychiatry, University of Naples SUN
  • Università degli Studi di Torino. Dipartimento di Neuroscienze
  • Servizio Psichiatrico Universitario di Diagnosi e Cura. Presidio Ospedaliero "San Salvatore" Università degli Studi dell'Aquila.
  • University Medical Center
  • Helse Bergen HF Haukeland University Hospital, Division of Psychiatry
  • Stavanger University Hospital
  • St Olavs Hospital avd Østmarka / INM NTNU
  • Instytut psychiatrii i neurologii
  • II Klinika Psychiatrii Uniwersytet Medyczny w Lublinie
  • Spitalul Clinic Judetean de Urgenta Arad - Clinica de Psihiatrie
  • Spitalul Clinic de Psihiatrie "Prof. Dr. Alexandru Obregia"
  • Spitalul Clinic de Psihiatrie "Prof. Dr. Alexandru Obregia
  • Spitalul de Psihiatrie si pentru Masuri de Siguranta, Sapoca, Buzau
  • Spitalul Clinic de Neuropsihiatrie Craiova
  • Sitalul Clinic Judetean Mures
  • Hospital Clínic de Barcelona. Unidad de Esquizofrenia
  • Hospital Universitario Marqués de Valdecilla, Servicio de Psiquiatría
  • Facultad de Medicina Center
  • Child and Adolescent Psychiatry Department. Hospital General Universitario Gregorio Marañón. Servicio Madrileño de Salud
  • West London Mental Health Trust. East Recovery Team
  • Greater Manchester West Mental Health NHS Foundation Trust
  • Edmund Ward, St Martins Hospital Littlebourne Road Canterbury
  • Imperial College, Centre for Mental Health, Faculty of Medicine,
  • Tees, Ask and Wearvalleys
  • Northumberland
  • Oxford Health NHS Foundation Trust
  • Surrey and Borders Partnership NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

aripiprazole oral

Aripiprazole depot

Paliperidone

Paliperidone palmitate

Arm Description

the recommended starting dose for aripiprazole is 10 or 15 mg/day with a maintenance dose of 15 mg/day administered on a once-a-day schedule without regard to meals.Aripiprazole is effective in a dose range of 10 to 30 mg/day.

The recommended starting and maintenance dose of aripiprazole depot is 400 mg. Titration of the dose of this medicinal product is not required. It should be administered once monthly as a single injection (no sooner than 26 days after the previous injection). After the first injection, treatment with 10 mg to 20 mg oral aripiprazole should be continued for 14 consecutive days to maintain therapeutic aripiprazole concentrations during initiation of therapy. If there are adverse reactions with the 400 mg dosage, reduction of the dose to 300 mg once monthly should be considered.

The recommended dose of paliperidone for the treatment of schizophrenia is 6 mg once daily, administered in the morning. Initial dose titration is not required. Some patients may benefit from lower or higher doses within the recommended range of 3 mg to 12 mg once daily. Dosage adjustment, if indicated, should occur only after clinical reassessment. When dose increases are indicated, increments of 3 mg/day are recommended and generally should occur at intervals of more than 5 days.

The first two administrations of paliperidone palmitate (150 mg at visit 3 and 100 mg one week later) need to be administered deep into the deltoid muscle in order to attain therapeutic concentrations rapidly. No oral supplementation with paliperidone is needed. Following the second dose, monthly maintenance doses can be administered in either the deltoid or gluteal muscle. The recommended monthly maintenance dose is 75 mg, although some patients may benefit from lower doses within the recommended range of 25 to 150 mg based on individual patient tolerability and/or efficacy.

Outcomes

Primary Outcome Measures

All cause discontinuation rates
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). Discontinuation consist of (multiple options are possible): the allocated treatment is stopped or used at doses outside the allowed range. medication is switched or augmented with another antipsychotic after visit 4 for more than 1 month continuously or for more than 3 months cumulative over the 18 months of the trial. a patient misses a monthly visit and does not show up after reminding him patient withdraws consent for the study. clinician decision to withdraw the patient.

Secondary Outcome Measures

Subjective Wellbeing under Neuroleptics
Change from baseline in Subjective Wellbeing under Neuroleptics
EuroQoL quality of life scale
Change from baseline in EuroQoL quality of life scale
Side effects assessment
Change from baseline in SMARTS (Systematic Monitoring of Adverse events Related to TreatmentS) and the Abnormal and Involuntary Movement Scale.
Assessment of cognitive functioning
Compare the combined oral medication group with the combined depot treatment arms regarding cognitive functioning
Assessment of Positive and Negative Symptom Scale
Compare the combined oral medication group with the combined depot treatment arms regarding changes in different dimensions of psychopathology of schizophrenia
Assessment of Personal and Social Performance Scale
Compare the combined oral medication group with the combined depot
Change from baseline of Personal and Social Performance Scale
Compare the combined oral medication group with the combined depot

Full Information

First Posted
May 21, 2014
Last Updated
August 31, 2020
Sponsor
UMC Utrecht
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1. Study Identification

Unique Protocol Identification Number
NCT02146547
Brief Title
European Long-acting Antipsychotics in Schizophrenia Trial
Acronym
EULAST
Official Title
European Long-acting Antipsychotics in Schizophrenia Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
February 2015 (Actual)
Primary Completion Date
August 26, 2020 (Actual)
Study Completion Date
August 26, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
UMC Utrecht

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Schizophrenia is a chronic psychiatric illness with periods of remission and relapse. Patients vary in the frequency and severity of relapse, time until relapse and time in remission. Discontinuation of antipsychotic medication is by far the most important reason for relapse. A possible method to optimize medication adherence is to treat patients with long-term, depot medication rather than oral medication. However, despite its apparent "common sense" this approach has neither been universally accepted by practicing psychiatrists nor unequivocally demonstrated in clinical trials. Therefore, in this study we aim to investigate possible advantages of depot medication over oral antipsychotics in an independently designed and conducted, randomized, pragmatic trial.
Detailed Description
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 we 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 we aim 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. In this pragmatic, randomized, open label, multicenter, multinational comparative trial, schizophrenic patients aged 18 years or older, having experienced the first psychosis between 6 months and 7 years ago,with an indication (patient or physician initiated) to receive medication or to switch to another antipsychotic drug, will enter the study. The study duration will be one month for the medication switch and then a follow-up of 18 months. Patients having refused to take part in the study will be asked to give consent and participate in a naturalistic follow-up, during which they will be followed with the Clinical Global Impression list (CGI) as closely related to the study schedule as possible, unless they also refuse this.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
depot, oral, antipsychotics, paliperidone, aripiprazole

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
536 (Actual)

8. Arms, Groups, and Interventions

Arm Title
aripiprazole oral
Arm Type
Active Comparator
Arm Description
the recommended starting dose for aripiprazole is 10 or 15 mg/day with a maintenance dose of 15 mg/day administered on a once-a-day schedule without regard to meals.Aripiprazole is effective in a dose range of 10 to 30 mg/day.
Arm Title
Aripiprazole depot
Arm Type
Active Comparator
Arm Description
The recommended starting and maintenance dose of aripiprazole depot is 400 mg. Titration of the dose of this medicinal product is not required. It should be administered once monthly as a single injection (no sooner than 26 days after the previous injection). After the first injection, treatment with 10 mg to 20 mg oral aripiprazole should be continued for 14 consecutive days to maintain therapeutic aripiprazole concentrations during initiation of therapy. If there are adverse reactions with the 400 mg dosage, reduction of the dose to 300 mg once monthly should be considered.
Arm Title
Paliperidone
Arm Type
Active Comparator
Arm Description
The recommended dose of paliperidone for the treatment of schizophrenia is 6 mg once daily, administered in the morning. Initial dose titration is not required. Some patients may benefit from lower or higher doses within the recommended range of 3 mg to 12 mg once daily. Dosage adjustment, if indicated, should occur only after clinical reassessment. When dose increases are indicated, increments of 3 mg/day are recommended and generally should occur at intervals of more than 5 days.
Arm Title
Paliperidone palmitate
Arm Type
Active Comparator
Arm Description
The first two administrations of paliperidone palmitate (150 mg at visit 3 and 100 mg one week later) need to be administered deep into the deltoid muscle in order to attain therapeutic concentrations rapidly. No oral supplementation with paliperidone is needed. Following the second dose, monthly maintenance doses can be administered in either the deltoid or gluteal muscle. The recommended monthly maintenance dose is 75 mg, although some patients may benefit from lower doses within the recommended range of 25 to 150 mg based on individual patient tolerability and/or efficacy.
Intervention Type
Drug
Intervention Name(s)
Aripiprazole
Other Intervention Name(s)
Abilify
Intervention Description
Administration in once-a-day schedule without regard to meals.
Intervention Type
Drug
Intervention Name(s)
Aripiprazole depot
Other Intervention Name(s)
Abilify maintena
Intervention Description
Abilify Maintena is an intramuscular (IM) depot formulation of oral aripiprazole. It provides the efficacy and safety profile of oral aripiprazole in a once-monthly injection.
Intervention Type
Drug
Intervention Name(s)
Paliperidone
Other Intervention Name(s)
Invega
Intervention Description
Administration once a day orally standardised in relation to food intake.
Intervention Type
Drug
Intervention Name(s)
Paliperidone palmitate
Other Intervention Name(s)
Xeplion
Intervention Description
In selected patients with schizophrenia and previous responsiveness to oral paliperidone or risperidone, Xeplion may be used without prior stabilization with oral treatment if psychotic symptoms are mild to moderate and a long-acting injectable is needed.
Primary Outcome Measure Information:
Title
All cause discontinuation rates
Description
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). Discontinuation consist of (multiple options are possible): the allocated treatment is stopped or used at doses outside the allowed range. medication is switched or augmented with another antipsychotic after visit 4 for more than 1 month continuously or for more than 3 months cumulative over the 18 months of the trial. a patient misses a monthly visit and does not show up after reminding him patient withdraws consent for the study. clinician decision to withdraw the patient.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Subjective Wellbeing under Neuroleptics
Description
Change from baseline in Subjective Wellbeing under Neuroleptics
Time Frame
18 months
Title
EuroQoL quality of life scale
Description
Change from baseline in EuroQoL quality of life scale
Time Frame
18 months
Title
Side effects assessment
Description
Change from baseline in SMARTS (Systematic Monitoring of Adverse events Related to TreatmentS) and the Abnormal and Involuntary Movement Scale.
Time Frame
18 months
Title
Assessment of cognitive functioning
Description
Compare the combined oral medication group with the combined depot treatment arms regarding cognitive functioning
Time Frame
18 months
Title
Assessment of Positive and Negative Symptom Scale
Description
Compare the combined oral medication group with the combined depot treatment arms regarding changes in different dimensions of psychopathology of schizophrenia
Time Frame
18 months
Title
Assessment of Personal and Social Performance Scale
Description
Compare the combined oral medication group with the combined depot
Time Frame
18 months
Title
Change from baseline of Personal and Social Performance Scale
Description
Compare the combined oral medication group with the combined depot
Time Frame
Baseline until 18 months
Other Pre-specified Outcome Measures:
Title
Comparison between depot arms and the oral treatment arms on the one side
Description
The comparisons will also be made between the depot arms and the oral treatment arms on the one side and the patients who are followed up naturalistically.Depot arms are compared regarding augmentation with oral antipsychotics after visit 4.
Time Frame
18 months
Title
Treatment success regarding outcomes in patients who have not given consent for the main trial
Description
compare treatment success regarding the outcomes mentioned above to those achieved in a group of patients who did not agree to participate in the trial but could be followed up with the CGI.
Time Frame
up to 18 months
Title
Compare side effects between combined oral medication groups & combined depot treatment
Description
Compare side effects and general wellbeing under antipsychotic medication between the combined oral medication groups with the combined depot treatment arms.
Time Frame
18 months
Title
Immune parameters
Description
Associations between immune parameters on the one hand, and primary as well as secondary outcome measures on the other.
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of schizophrenia as defined by DSM-IV-R (Diagnostic and Statistical Manual) as determined by the M.I.N.I.plus Age 18 or older. 3. The first psychosis occurred at least 6 months and no more than 7 years ago.* If patients are using an antipsychotic drug, a medication switch is currently under consideration. Capable of providing written informed consent Time of first psychosis is defined as the first contact with a health care professional in relation to psychotic symptoms. Exclusion Criteria: Intolerance / hypersensitivity to both* of the drugs (including active substances, metabolites and excipients) in this study including oral paliperidone and aripiprazole and/or hypersensitivity to risperidone. Pregnancy or lactation. Patients who are currently using clozapine. Patients who do not fully comprehend the purpose or are not competent to make a rational decision whether or not to participate. Patients with a documented history of intolerance to both* of the study medications and/or a documented history of non-response to a treatment with both* study drugs of at least 6 weeks within the registered dose range.7. Patients who have been treated with an investigational drug within 30 days prior to screening. 8. Simultaneous participation in another intervention study (neither medication or psychosocial intervention). * If intolerance/hypersensitivity or non-response in the past to one of the compounds is documented, the patient can still participate; however, randomization will take place by blocking that specific compound. That is, the patient will be randomized on either the oral or the depot arm of the other compound. This procedure of blocking one compound is also accepted for patients who have experienced too many side effects to one of the compounds in the past, as documented in the patient's medical record. The decision to block that specific compound for randomization in these cases is up to the discretion of the treating physician who will carefully balance this decision and clearly document it in the medical record.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rene S Kahn, professor
Organizational Affiliation
UMC Utrecht
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wolfgang Fleischhacker, professor
Organizational Affiliation
Department of Biological Psychiatry, Innsbruck University Clinics
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Davidson, professor
Organizational Affiliation
Department of Psychiatry, Sackler Faculty of Medicine, Tel Aviv University, Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Biological Psychiatry, Innsbruck University Clinics
City
Innsbruck
State/Province
Anichstrasse 35
ZIP/Postal Code
A-6020
Country
Austria
Facility Name
Psychosoziale Dienste
City
Vienna
State/Province
Modecenterstraße
ZIP/Postal Code
1030
Country
Austria
Facility Name
ZNA, department of Psychiatry, locatie Stuivenberg
City
Antwerp
State/Province
Lange Beeldekensstraat 267
ZIP/Postal Code
2060
Country
Belgium
Facility Name
Psychiatrisch Ziekenhuis Duffel
City
Antwerp
State/Province
Stationsstraat 22C
ZIP/Postal Code
2570
Country
Belgium
Facility Name
University Hospital of Neurology and Psychiatry 'St. Naum' 1
City
Sofia
State/Province
Louben Roussev Str.
ZIP/Postal Code
1113
Country
Bulgaria
Facility Name
Psychiatrická klinika LF UK
City
Hradec Králové
State/Province
Fakultní Nemocnice
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Dr. Ustohal
City
Brno
Country
Czechia
Facility Name
Dr. Mohr
City
Praha
Country
Czechia
Facility Name
Center for Neuropsychiatric Research
City
Glostrup
State/Province
Ndr. Ringvej
ZIP/Postal Code
2600
Country
Denmark
Facility Name
Klinik und Poliklinik für Psychiatrie und Psychotherapie der Heinrich-Heine-Universität
City
Düsseldorf
State/Province
Bergische Landstraße 2
ZIP/Postal Code
40629
Country
Germany
Facility Name
Technische Universität München (TUM
City
München,
State/Province
Ismaningerstrasse 22
ZIP/Postal Code
81675
Country
Germany
Facility Name
Klinik für Psychiatrie, Psychotherapie und Psychosomatik der Martin-Luther-Universität
City
Halle
State/Province
Julius-Kühn-Straße 7
ZIP/Postal Code
06112
Country
Germany
Facility Name
Department of Psychiatry and Psychotherapy
City
München
State/Province
Nussbaumstrasse 7
ZIP/Postal Code
80336
Country
Germany
Facility Name
National and Kapodistrian University of Athens Medical School, Eginition Hospital
City
Athens
Country
Greece
Facility Name
Dr. Csekey
City
Balassagyarmat
Country
Hungary
Facility Name
Department of Psychiatry and Psychotherapy, Semmelweis University
City
Budapest
Country
Hungary
Facility Name
Abravanel Mental Health Center
City
Bat-Yam
Country
Israel
Facility Name
Be'er-Ness Mental Health Center
City
Be'er Ya'aqov
Country
Israel
Facility Name
The Jerusalem Mental Health Center
City
Jerusalem
Country
Israel
Facility Name
Lev-Hasharon Medical Center for Mental Health
City
Pardesiyya
Country
Israel
Facility Name
Geha Medical Health Center
City
Petach-Tikva
Country
Israel
Facility Name
The Chaim Sheba Medical Center
City
Tel-Hashomer
ZIP/Postal Code
52621
Country
Israel
Facility Name
Department of Psychiatry, University of Naples SUN
City
Naples
State/Province
Largo Madonna Delle Grazie 1
ZIP/Postal Code
80138
Country
Italy
Facility Name
Università degli Studi di Torino. Dipartimento di Neuroscienze
City
Turin
State/Province
Sezione Di Psichiatriavia Cherasco, 11
ZIP/Postal Code
10126
Country
Italy
Facility Name
Servizio Psichiatrico Universitario di Diagnosi e Cura. Presidio Ospedaliero "San Salvatore" Università degli Studi dell'Aquila.
City
L'Aquila
Country
Italy
Facility Name
University Medical Center
City
Utrecht
Country
Netherlands
Facility Name
Helse Bergen HF Haukeland University Hospital, Division of Psychiatry
City
Bergen
ZIP/Postal Code
5021
Country
Norway
Facility Name
Stavanger University Hospital
City
Stavanger
Country
Norway
Facility Name
St Olavs Hospital avd Østmarka / INM NTNU
City
Trondheim
ZIP/Postal Code
7441
Country
Norway
Facility Name
Instytut psychiatrii i neurologii
City
Warsaw
State/Province
Sobieskiego 9
ZIP/Postal Code
02-957
Country
Poland
Facility Name
II Klinika Psychiatrii Uniwersytet Medyczny w Lublinie
City
Lublin
State/Province
Ul. Głuska 1
ZIP/Postal Code
20-439
Country
Poland
Facility Name
Spitalul Clinic Judetean de Urgenta Arad - Clinica de Psihiatrie
City
Arad
Country
Romania
Facility Name
Spitalul Clinic de Psihiatrie "Prof. Dr. Alexandru Obregia"
City
Bucharest
Country
Romania
Facility Name
Spitalul Clinic de Psihiatrie "Prof. Dr. Alexandru Obregia
City
Bucharest
Country
Romania
Facility Name
Spitalul de Psihiatrie si pentru Masuri de Siguranta, Sapoca, Buzau
City
Buzău
Country
Romania
Facility Name
Spitalul Clinic de Neuropsihiatrie Craiova
City
Craiova
Country
Romania
Facility Name
Sitalul Clinic Judetean Mures
City
Targu Mureş
Country
Romania
Facility Name
Hospital Clínic de Barcelona. Unidad de Esquizofrenia
City
Barcelona
State/Province
C/Villarroel, 170. Escalera12, Planta 0
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Universitario Marqués de Valdecilla, Servicio de Psiquiatría
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39011
Country
Spain
Facility Name
Facultad de Medicina Center
City
Oviedo
State/Province
Julián Clavería S/n
ZIP/Postal Code
33006
Country
Spain
Facility Name
Child and Adolescent Psychiatry Department. Hospital General Universitario Gregorio Marañón. Servicio Madrileño de Salud
City
Madrid
Country
Spain
Facility Name
West London Mental Health Trust. East Recovery Team
City
London
State/Province
Avenue House 43-47 Avenue Road
ZIP/Postal Code
W38NJ
Country
United Kingdom
Facility Name
Greater Manchester West Mental Health NHS Foundation Trust
City
Manchester
State/Province
Crowell House, Cromwell Road
Country
United Kingdom
Facility Name
Edmund Ward, St Martins Hospital Littlebourne Road Canterbury
City
Kent
Country
United Kingdom
Facility Name
Imperial College, Centre for Mental Health, Faculty of Medicine,
City
London
Country
United Kingdom
Facility Name
Tees, Ask and Wearvalleys
City
Middlesbrough
Country
United Kingdom
Facility Name
Northumberland
City
Newcastle
Country
United Kingdom
Facility Name
Oxford Health NHS Foundation Trust
City
Oxford
Country
United Kingdom
Facility Name
Surrey and Borders Partnership NHS Foundation Trust
City
Surrey
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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European Long-acting Antipsychotics in Schizophrenia Trial

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