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European Long-acting Antipsychotics in Schizophrenia Trial

Information source: UMC Utrecht
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Schizophrenia

Intervention: Aripiprazole (Drug); Aripiprazole depot (Drug); Paliperidone (Drug); Paliperidone palmitate (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: UMC Utrecht

Official(s) and/or principal investigator(s):
Rene S Kahn, professor, Principal Investigator, Affiliation: UMC Utrecht
Wolfgang Fleischhacker, professor, Principal Investigator, Affiliation: Department of Biological Psychiatry, Innsbruck University Clinics
Michael Davidson, professor, Principal Investigator, Affiliation: Department of Psychiatry, Sackler Faculty of Medicine, Tel Aviv University, Israel

Overall contact:
Rene Kahn, professor, Phone: +31 887556025, Email: R.Kahn@umcutrecht.nl

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.

Clinical Details

Official title: European Long-acting Antipsychotics in Schizophrenia Trial

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: All cause discontinuation rates

Secondary outcome:

Subjective Wellbeing under Neuroleptics

EuroQoL quality of life scale

Side effects assessment

Assessment of cognitive functioning

Assessment of Positive and Negative Symptom Scale

Assessment of Personal and Social Performance Scale

Change from baseline of Personal and Social Performance Scale

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 1-7 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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. The first psychosis occurred at least one year 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 Exclusion Criteria: 1. Intolerance / hypersensitivity to one 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 any of the study medications and/or a documented history of non-response to a treatment with one of the study drugs of at least 6 weeks within the registered dose range. 6. Forensic patients. 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).

Locations and Contacts

Rene Kahn, professor, Phone: +31 887556025, Email: R.Kahn@umcutrecht.nl

National and Kapodistrian University of Athens Medical School, Eginition Hospital, Athens, Greece; Not yet recruiting
Nikos Stefanis, Prof. Dr., Email: nistefan@med.uoa.gr

Department of Psychiatry and Psychotherapy, Semmelweis University, Budapest, Hungary; Not yet recruiting
Istvan Bitter, Prof. Dr., Email: bitter.istvan@med.semmelweis-univ.hu

Abravanel Mental Health Center, Bat-Yam, Israel; Not yet recruiting
Marnina Swartz, Dr., Email: marninavs@gmail.com

Be'er-Ness Mental Health Center, Be'er Yaakov, Israel; Not yet recruiting
Marina Kupchik, Dr., Email: marinakup@gmail.com

The Jerusalem Mental Health Center, Kfar Shaul, Israel; Recruiting
Alexander Teitelbaum, Dr., Email: alex.teitelbaum@psjer.health.gov.il

Lev-Hasharon Medical Center for Mental Health, Pardesia, Israel; Not yet recruiting
Igor Oyffe, Dr., Email: ioyffe@gmail.com

Geha Medical Health Center, Petach-Tikva, Israel; Not yet recruiting
Avi Volevski, professor, Email: valevski@gmail.com

The Chaim Sheba Medical Center, Tel-Hashomer 52621, Israel; Recruiting
Mark Weiser, Profesor,Dr., Email: mweiser@013net.net

Servizio Psichiatrico Universitario di Diagnosi e Cura. Presidio Ospedaliero "San Salvatore" Università degli Studi dell'Aquila., L'Aquila, Italy; Not yet recruiting
Alessandro Rossi, Dr., Email: alessandro.rossi@cc.univaq.it

Univeristy Medical Center, Utrecht, Netherlands; Not yet recruiting

Helse Bergen HF Haukeland University Hospital, Division of Psychiatry, Bergen 5021, Norway; Not yet recruiting
Erik Johnsen, Dr., Email: erik.johnsen@helse-bergen.no

Stavanger University Hospital, Stavenger, Norway; Not yet recruiting
Peter Drosos, Dr., Email: petros.drosos@sus.no
Tor Larsen, Email: tkmaclarsen@me.com

St Olavs Hospital avd Østmarka / INM NTNU, Trondheim 7441, Norway; Not yet recruiting
Solveig Klebo Reitan, Ass Prof Dr, Email: Solveig.Klebo.Reitan@stolav.no

Spitalul Clinic Judetean de Urgenta Arad - Clinica de Psihiatrie, Arad, Romania; Not yet recruiting
Delia Marina Podea, prof.dr., Phone: 0722583757, Email: deliapodea@yahoo.com

Spitalul Clinic de Psihiatrie "Prof. Dr. Alexandru Obregia, Bucharest, Romania; Not yet recruiting
Adela Ciobanu, dr., Phone: 0723671301, Email: adela.ciobanu@yahoo.com

Spitalul Clinic de Psihiatrie "Prof. Dr. Alexandru Obregia", Bucharest, Romania; Not yet recruiting
Valentin Matei, Dr., Phone: 0721243869, Email: valipmatei@yahoo.com

Spitalul Clinic de Neuropsihiatrie Craiova, Craiova, Romania; Not yet recruiting
Dragos Marinescu, prof.dr., Phone: 0723491111, Email: marinescu_psy@yahoo.com

Spitalul Clinic de Psihiatrie "SOCOLA", Iasi, Romania; Not yet recruiting
Cristinel Stefanescu, prof.dr., Phone: 0744518195, Email: cristinel.stefanescu@gmail.com

Sitalul Clinic Judetean Mures, Mures, Romania; Not yet recruiting
Aurel Nirestean, prof.dr., Phone: 0746030006, Email: aurelnirestean@yahoo.com

Child and Adolescent Psychiatry Department. Hospital General Universitario Gregorio Marañón. Servicio Madrileño de Salud, Madrid, Spain; Not yet recruiting
Celso Arango, Prof. Dr., Email: carango@hggm.es

Edmund Ward, St Martins Hospital Littlebourne Road Canterbury, Kent, United Kingdom; Recruiting
George Umoh, Dr., Email: ekwere.umoh@kmpt.nhs.uk

Imperial College, Centre for Mental Health, Faculty of Medicine,, London, United Kingdom; Not yet recruiting
Paola Dazzan, Dr., Email: paola.dazzan@kcl.ac.uk

Oxford Health NHS Foundation Trust, Oxford, United Kingdom; Not yet recruiting
John Geddes, Prof. Dr., Email: john.geddes@psych.ox.ac.uk

Surrey and Borders Partnership NHS Foundation Trust, Surrey, United Kingdom; Recruiting
Ramin Nilforooshan, Dr., Email: Ramin.Nilforooshan@sabp.nhs.uk

Department of Biological Psychiatry, Innsbruck University Clinics, Innsbruck, Anichstrasse 35 A-6020, Austria; Recruiting
Alex Hofer, Ass Prof Dr, Email: a.hofer@i-med.ac.at

West London Mental Health Trust. East Recovery Team, London, Avenue House 43-47 Avenue Road W38NJ, United Kingdom; Not yet recruiting
Sofia Pappa, Dr., Email: sofia.pappa@wlmht.nhs.uk

Klinik und Poliklinik für Psychiatrie und Psychotherapie der Heinrich-Heine-Universität, Düsseldorf, Bergische Landstraße 2 40629, Germany; Not yet recruiting
Joachim Cordes, Dr., Email: joachim.cordes@lvr.de

Hospital Clínic de Barcelona. Unidad de Esquizofrenia, Barcelona, C/Villarroel, 170. Escalera12, planta 0 08036, Spain; Not yet recruiting
Miquel Bernardo, Dr., Email: BERNARDO@clinic.ub.es

Hospital Universitario Marqués de Valdecilla, Servicio de Psiquiatría, Santander, Cantabria 39011, Spain; Not yet recruiting
Benedicto Crespo Facorro, Dr., Phone: +34942202545, Email: benedicto.crespo@unican.es
Noemi De La Fuente Gonzalez, Phone: +34942203826, Email: nde@humv.es

Greater Manchester West Mental Health NHS Foundation Trust, Manchester, Crowell House, Cromwell Road, United Kingdom; Not yet recruiting
Peter Haddad, Dr., Email: peter.haddad@gmw.nhs.uk

Psychiatrická klinika LF UK, Hradec Králové, Fakultní nemocnice 500 05, Czech Republic; Not yet recruiting
Jan Libiger, prof. MUDr., Email: libigerj@lfhk.cuni.cz

Technische Universität München (TUM, München,, Ismaningerstrasse 22 81675, Germany; Not yet recruiting
Stefan Leucht, Prof Dr med, Email: stefan.leucht@lrz.tum.de

Klinik für Psychiatrie, Psychotherapie und Psychosomatik der Martin-Luther-Universität, Halle, Julius-Kühn-Straße 7 06112, Germany; Not yet recruiting
Dan Rujescu, Prof. Dr., Email: dan.rujescu@uk-halle.de

Facultad de Medicina Center, Oviedo, Julián Clavería s/n 33006, Spain; Not yet recruiting
Julio Bobes, Prof. Dr., Email: bobes@uniovi.es

ZNA, department of Psychiatry, locatie Stuivenberg, Antwerp, Lange Beeldekensstraat 267 2060, Belgium; Recruiting
Jurjen Luykx, Dr., Email: Jurjen.Luykx@zna.be

Department of Psychiatry, University of Naples SUN, Naples, Largo Madonna delle Grazie 1 80138, Italy; Recruiting
Silvana Galderisi, Prof. Dr., Email: Silvana.Galderisi@gmail.com

University Hospital of Neurology and Psychiatry 'St. Naum' 1, Sofia, Louben Roussev str. 1113, Bulgaria; Not yet recruiting
Luchezar Hranov, Ass Prof Dr, Email: lucho.hranov@gmail.com

Psychosoziale Dienste, Vienna, Modecenterstraße 1030, Austria; Recruiting
Martin Kopeinig, Prim. Dr., Email: chapost@psd-wien.at
Psota, Dr., Email: chapost@psd-wien.at

Center for Neuropsychiatric Research, Glostrup, Ndr. Ringvej 2600, Denmark; Not yet recruiting
Birthe Glenthoej, Prof dr med, Email: birgle01@glo.regionh.dk

Department of Psychiatry and Psychotherapy, München, Nussbaumstrasse 7 80336, Germany; Not yet recruiting
Alkomiet Hasan, PD Dr., Email: alkomiet.hasan@med.uni-muenchen.de

Università degli Studi di Torino. Dipartimento di Neuroscienze, Turin, Sezione di Psichiatriavia Cherasco, 11 10126, Italy; Recruiting
Paola Rocca, MD, Email: paola.rocca@unito.it

Instytut psychiatrii i neurologii, Warsaw, Sobieskiego 9 02-957, Poland; Not yet recruiting
Marek Jarema, Prof dr med, Email: jarema@ipin.edu.pl

Psychiatrisch Ziekenhuis Duffel, Antwerp, Stationsstraat 22C 2570, Belgium; Recruiting
Manuel Morrens, Prof. Dr., Email: manuel.morrens@uantwerpen.be
Glenn Dumont, Dr., Email: glenn.dumont@uantwerpen.be

Department of Adult Psychiatry, University of Medical Sciences, Poznan, Szpitalna 27/33 60-572, Poland; Not yet recruiting
Janusz Rybakowski, Prof. Dr., Email: janusz.rybakowski@gmail.com

II Klinika Psychiatrii Uniwersytet Medyczny w Lublinie, Lublin, ul. Głuska 1 20-439, Poland; Not yet recruiting
Marcin Olajossy, dr. med., Email: olajossy@o2.pl

Additional Information

Starting date: February 2015
Last updated: July 28, 2015

Page last updated: August 23, 2015

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