.

Fecha: 2015-04. Area: Psiquiatría y Psicología [F] - Desórdenes mentales [F03].

DATOS GENERALES

IDENTIFICADOR 2014-002765-30.

TIPO Ensayo Clínico.

TITULO PÚBLICO .

ESTADO Reclutando.

ÁREA TERAPÉUTICA Psiquiatría y Psicología [F] - Desórdenes mentales [F03].

SEXO Ambos.

INCLUYE PLACEBO No.

INFORMACIÓN

TITULO CIENTÍFICO " ESTUDIO EUROPEO DE NTIPSICÓTICOS DE ACCIÓN PROLONGADA EN ESQUIZOFRENIA".

INDICACIÓN PÚBLICA Esquizofrenia asociada a pensamientos y percepciones distorsionadas.

INDICACIÓN CIENTÍFICA Esquizofrenia ICD-10 código F20.

CRITERIOS INCLUSIÓN Diagnosis of schizophrenia as defined by DSM-IV-R 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.

CRITERIOS EXCLUSIÓN 1. Intolerance / hypersensitivity to one of the drugs (including active substances, metabolites and excipients) in this study including oral risperidone, paliperidone and aripiprazole.
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 non-response and/or intolerance to any of the study medications.
6. Forensic patients.
7.Patients who have been treated with an investigational drug within 30 days prior to screening.

VARIABLES PRINCIPALES The primary objective of this study is to compare all cause discontinuation rates between treatment with the combined oral treatment groups (aripiprazole and paliperidone) to the combined depot treatment groups (aripiprazole depot and paliperidone depot) during 18 months of treatment. This overall measure best reflects effectiveness encompassing in one measurement efficacy, adverse events, and patient?s and physician's attitude towards the drug.
Discontinuation consist of :
? 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 (patients who do not show up for appointments will be contacted once).
? patient withdraws consent for the study.
? clinician decision to withdraw the patient.

VARIABLES SECUNDARIAS Although the trial is only powered for the primary objective, a number of secondary objectives will be considered and investigated:
? comparing the combined oral medication group with the combined depot treatment arms regarding changes in different dimensions of psychopathology of schizophrenia, global psychosocial functioning, quality of life, resource utilization and safety measures.
? comparing 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.
? comparing side effects and general wellbeing under antipsychotic medication between the combined oral medication groups with the combined depot treatment arms.
? comparing the combined oral medication group with the combined depot treatment arms regarding cognitive functioning.
? associations between immune parameters on the one hand, and primary as well as secondary outcome measures on the other.

OBJETIVO PRINCIPAL 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.

OBJETIVO SECUNDARIO ? compare the combined oral medication group with the combined depot treatment arms regarding changes in different dimensions of psychopathology of schizophrenia, global psychosocial functioning, quality of life, resource utilization and safety measures.
? 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.
? compare side effects and general well-being under antipsychotic medication between the combined oral medication groups with the combined depot treatment arms.
? compare the combined oral medication group with the combined depot treatment arms regarding cognitive functioning and aggression incidents.

MOMENTOS PRINCIPALES DE EVALUACIÓN Investigators will be encouraged to keep patients in the trial for the full 18 month duration regardless of them meeting discontinuation criteria or not.

MOMENTOS SECUNDARIOS DE EVALUACIÓN Investigators will be encouraged to keep patients in the trial for the full 18 month duration regardless of them meeting discontinuation criteria or not.

JUSTIFICACION En este estudio se pretende investigar las posibles ventajas de la medicación depot sobre los antipsicóticos orales en un ensayo diseñado
y llevado a cabo de forma independiente, aleatorizado y pragmático comparando todos los tipos de causa de suspensión de tratamiento en pacientes con esquizofrenia asignados al azar a uno de los dos fármacos de
depot con los pacientes asignados al azar a una de las dos formulaciones orales de la misma medicación durante un período de seguimiento de 18 meses.

POBLACIÓN

VOLUNTARIOS SANOS No. PACIENTES Si. POB. VULNERABLE No. MUJERES USAN ANTICONCEPTIVOS No. MUJERES NO USAN ANTICONCEPTIVOS No. MUJERES EMBARAZADAS No. MUJERES EN PERÍODO DE LACTANCIA No. SITUACIÓN DE URGENCIA No. SUJETOS INCAPACES DE OTORGAR CONSENTIMIENTO No. INTRAÚTEROS No. PREMATUROS No. RECIEN NACIDOS No. PREESCOLAR No. NIÑOS No. ADOLESCENTES No. ADULTOS Si. MAYORES DE 64 No. MENORES DE 18 No. TOTAL 600.

PROPÓSITO

DIAGNÓSTICO No. PROFILAXIS No. TRATAMIENTO Si. SEGURIDAD Si. EFICACIA Si. FARMACOCINÉTICA No. FARMACODINÁMICA No. BIOEQUIVALENCIA No. DOSIS No. FARMACOGENÉTICA No. FARMACOGENÓMICA No. FARMACOECONÓMICA No. FASE I No. FASE II No. FASE III No. FASE IV Si.

CALENDARIO

FECHA PUBLICACIÓN 17/06/2016. FECHA AUTORIZACIÓN 21/04/2015. FECHA DICTAMEN 16/12/2015. FECHA INICIO PREVISTA 01/10/2014. FECHA INICIO REAL 10/09/2015. FECHA ÚLTIMA ACTUALIZACIÓN 16/06/2016.

PROMOTOR

NOMBRE PROMOTOR EGRIS. DOMICILIO PROMOTOR Heidelberglaan 100 3584CX Utrecht. PERSONA DE CONTACTO Celso Arango - Celso Arango. TELÉFONO +34 91 4269232. FAX . FINANCIADOR Egris. PAIS Holanda.

CENTROS

CENTRO 1: HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑÓN

NOMBRE CENTRO HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑÓN. LOCALIDAD CENTRO MADRID. PROVINCIA MADRID. COMUNIDAD AUTÓNOMA MADRID. SITUACION Inactivo.

CENTRO 2: HOSPITAL UNIVERSITARIO CENTRAL DE ASTURIAS

NOMBRE CENTRO HOSPITAL UNIVERSITARIO CENTRAL DE ASTURIAS. LOCALIDAD CENTRO OVIEDO. PROVINCIA ASTURIAS. COMUNIDAD AUTÓNOMA ASTURIAS. SITUACION Inactivo.

CENTRO 3: HOSPITAL UNIVERSITARIO MARQUÉS DE VALDECILLA

NOMBRE CENTRO HOSPITAL UNIVERSITARIO MARQUÉS DE VALDECILLA. LOCALIDAD CENTRO SANTANDER. PROVINCIA CANTABRIA. COMUNIDAD AUTÓNOMA CANTABRIA. SITUACION Activo. DEPARTAMENTO Psiquiatría.

CENTRO 4: HOSPITAL CLÍNIC I PROVINCIAL DE BARCELONA

NOMBRE CENTRO HOSPITAL CLÍNIC I PROVINCIAL DE BARCELONA. LOCALIDAD CENTRO BARCELONA. PROVINCIA BARCELONA. COMUNIDAD AUTÓNOMA CATALUÑA. SITUACION Activo.

MEDICAMENTOS

MEDICAMENTO 1:

TIPO INTERVENCIÓN Comparador. NOMBRE INTERVENCIÓN Abilify. DETALLE 18 months. FORMA FARMACÉUTICA Comprimido. HUÉRFANO No.

MEDICAMENTO 2:

TIPO INTERVENCIÓN Experimental. NOMBRE INTERVENCIÓN Abilify Maintena. DETALLE 18 months. FORMA FARMACÉUTICA Polvo y disolvente para suspensión inyectable. HUÉRFANO No.

MEDICAMENTO 3:

TIPO INTERVENCIÓN Experimental. NOMBRE INTERVENCIÓN Xeplion. NOMBRE CIENTÍFICO Xeplion. DETALLE 18 months. FORMA FARMACÉUTICA Prolonged-release suspension for injection. HUÉRFANO No.

MEDICAMENTO 4:

TIPO INTERVENCIÓN Comparador. NOMBRE INTERVENCIÓN Invega. DETALLE 18 months. FORMA FARMACÉUTICA Comprimido de liberación prolongada. HUÉRFANO No.

Fuente de datos: REEC.