European Long-acting Antipsychotics in Schizophrenia Trial (EULAST)
Schizophrenia
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring depot, oral, antipsychotics, paliperidone, aripiprazole
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.
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
Active Comparator
Active Comparator
Active Comparator
Active Comparator
aripiprazole oral
Aripiprazole depot
Paliperidone
Paliperidone palmitate
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.