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Clinical Trial to Evaluate the Efficacy of Treatment vs Discontinuation in a First Episode of Non-affective Psychosis

Information source: Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Psychosis Nos/Other

Intervention: Discontinuation antipsychotic treatment (Drug); Antipsychotic treatment (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Fundación Pública Andaluza Progreso y Salud

Official(s) and/or principal investigator(s):
Miguel Ruiz Veguilla, MD, PhD, Study Chair, Affiliation: Virgen del Rocío Hospital

Overall contact:
Clara M. Rosso Fernández, MD, Phone: 0034955013414, Email: claram.rosso.sspa@juntadeandalucia.es

Summary

The purpose of this study is to assess if patients who continue with antipsychotic treatment for 12 or more months show the same risk of relapse (measured by PANSS) that patients with the same medical condition who have followed a discontinuation treatment scheme based in the presence of prodromes. The candidates should accomplish the following criteria: first episode of non-affective psychosis who have followed antipsychotic treatment for 12 months and who have already shown remission criteria.

Clinical Details

Official title: Randomized Multicentric Open-label Phase III Clinical Trial to Evaluate the Efficacy of Continual Treatment Versus Discontinuation Based in the Presence of Prodromes in a First Episode of Non-affective Psychosis.

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Risk of relapse

Detailed description: Randomized, open label, multicenter, phase III clinical trial. Number of subjects: 104. Age

range: 18 - 55 years of both sex.

Timepoints for evaluation: Every two weeks, during the first six months after initiation of treatment discontinuation/continuation. Every four weeks during the remaining six months, to complete a total follow-up scheme of 12 months.

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Adult age from 18 to 55 years old

- Non-affective psychosis diagnosis (schizophrenia, schizoaffective, schizophreniform

disorders, acute psychosis, other psychosis according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV).

- Antipsychotic treatment for 12 months since clinical stabilization. Clinical

stabilization is defined in case of admission by medical discharge (not including voluntary discharge). In case of voluntary discharge or no admission to hospital, clinical stabilization can be defined by the psychiatrist according to medical history and the information provided by the family.

- No changes in the antipsychotic doses in the last 4 months.

- No suicide attempts in the last 12 months.

- Patient who shows remission criteria.

- Signed informed consent form.

Exclusion Criteria:

- Patient who is not fluent in Spanish language

- Patient who takes mood stabilizers (Lithium, antiepileptic drugs...)

- Dependency on alcohol or other substances of abuse (cannabis, cocaine...)

- History of brain injury with loss of consciousness for more than 1 hour, stroke or

other central nervous system disorders.

- Intelligence testing (IQ) less than 70.

- Suicide attempt from stabilization.

- Pregnancy or planning to become pregnant during the study.

Locations and Contacts

Clara M. Rosso Fernández, MD, Phone: 0034955013414, Email: claram.rosso.sspa@juntadeandalucia.es

Hospital de Basurto, Bilbao 48013, Spain; Not yet recruiting
Sonia Bustamante Madariaga, MD, Phd, Phone: 0034944 006137, Email: sonia.bustamantemadariaga@osakidetza.net
Sonia Bustamante Madariaga, MD, PhD, Principal Investigator

Lafora Hospital, Madrid 28049, Spain; Not yet recruiting
Juan Dios Molina Martín, MD, PhD, Email: jmolinamar@hotmail.com
Juan Dios Molina Martín, MD, PhD, Principal Investigator

Mental Health Unit Tetuán, Madrid 28003, Spain; Not yet recruiting
Mariano Hernández Monsalve, MD, PhD, Phone: 0034915347363, Email: hergoico@gmail.com
Ruth Berdún Pe, MD, Email: ruthberdun@yahoo.es
Mariano Hernández Monsalve, MD, PhD, Principal Investigator

Hospital Carlos Haya, Málaga 29009, Spain; Recruiting
Fermín Mayoral Cleríes, Md, PhD, Email: fermin.mayoral.sspa@juntadeandalucia.es
Fermín Mayoral Cleríes, MD, PhD, Principal Investigator

Virgen del Rocío Hospital, Seville 41013, Spain; Recruiting
Clara M. Rosso Fernández, MD, Phone: 0034955013414, Email: claram.rosso.sspa@juntadeandalucia.es
Miguel Ruiz Veguilla, MD, PhD, Phone: 0034955013414, Email: mruizveguilla@yahoo.com
Miguel Ruiz Veguilla, MD, PhD, Principal Investigator

Mental Health Unit Villamartín, Villamartín, Cádiz 11650, Spain; Recruiting
José María Mongil San Juan, MD, Phone: 0034956040209, Email: cheman45@gmail.com
José María Mongil San Juan, MD, Principal Investigator

Mental Health Unit Baza, Baza, Granada 18800, Spain; Recruiting
Eva Bravo Barba, MD, Email: eva.bravo.barba@gmail.com
Eva Bravo Barba, MD, Principal Investigator

Mental Health Unit Motril, Motril, Granada 18600, Spain; Recruiting
María Luisa Barrigón Estévez, MD, Phone: 0034958038849, Email: marial.barrigon.sspa@juntadeandalucia.es
María Luisa Barrigón Estévez, MD, Principal Investigator

Mental Health Unit Andújar, Andújar, Jaén 23740, Spain; Recruiting
Fernando Sarramea Crespo, MD, PhD, Phone: 0034953021717, Email: fernandosarramea@hotmail.com
Farnando Sarramea Crespo, MD, PhD, Principal Investigator

Mental Health Unit Martos, Martos, Jaén 23600, Spain; Recruiting
Miguel Ortigosa Luque, MD, Email: migueortigosa@hotmail.com
Miguel Ortigosa Luque, MD, Principal Investigator

Mental Health Unit Miraflores, Alcobendas, Madrid 28100, Spain; Not yet recruiting
María Luisa Zamarro Arraz, MD, PhD, Phone: 0034916530108, Email: zamarroluisa@yahoo.es
María Luisa Zamarro Arraz, MD, PhD, Principal Investigator

Hospital Infanta Sofía, San Sebastian de los Reyes, Madrid 28702, Spain; Not yet recruiting
María Rosario Gutiérrez Labrador, MD, Email: rosagutierrez@psiquiatra.e.telefonica.net
María Rosario Guitiérrez Labrador, MD, Principal Investigator

Mental Health Unit Valle del Guadalhorce, Cártama, Málaga 29580, Spain; Not yet recruiting
Daniel Gutiérrez Castillo, MD, Phone: 0034951033931, Email: dgutierrezcastillo@gmail.com
Daniel Gutiérrez Castillo, MD, Principal Investigator

Mental Health Unit Las Lagunas, Fuengiróla, Málaga 29650, Spain; Not yet recruiting
María Isabel Osuna Carmona, MD, Email: maribelosunac@hotmail.com
María Isabel Osuna Carmona, MD, Principal Investigator

Fundación Argibide, Pamplona, Navarra 31007, Spain; Not yet recruiting
Ignacio Mata Pastor, MD, PhD, Phone: 0034948266650, Email: nacho.mata70@gmail.com
Ignacio Mata Pastor, MD, PhD, Principal Investigator

Hospital El Tomillar, Dos Hermanas, Seville 41700, Spain; Recruiting
Joaquín Carlos Martín Muñoz, MD, PhD, Phone: 0034955016083, Email: joaquinmartin@hotmail.com
Joaquín Carlos Martín Muñoz, MD, PhD, Principal Investigator

Hospital Francesc de Borja, Gandía, Valencia 46700, Spain; Recruiting
María Lacruz Silvestre, MD, PhD, Email: maria.lacruz.silvestre@gmail.com
María Lacruz Silvestre, MD, PhD, Principal Investigator

Additional Information

Starting date: November 2012
Last updated: December 4, 2014

Page last updated: August 23, 2015

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