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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Fundación Pública Andaluza Progreso y Salud
Sponsor:
Collaborator:
Instituto de Salud Carlos III
Information provided by (Responsible Party):
Fundación Pública Andaluza Progreso y Salud
ClinicalTrials.gov Identifier:
NCT01765829
First received: January 3, 2013
Last updated: January 8, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Psychosis Nos/Other
Drug: Discontinuation antipsychotic treatment
Drug: Antipsychotic treatment
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Fundación Pública Andaluza Progreso y Salud:

Primary Outcome Measures:
  • Risk of relapse [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 104
Study Start Date: November 2012
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Antipsychotic treatment

Antipsychotic treatment according to common clinical practice

Drugs: Aripiprazole, Olanzapine, Zuclopenthixol, Clotiapine, Flupentixol, Risperidone, Sulpiride, Trifluoperazine, Haloperidol, Quetiapine, Paliperidone, Chlorpromazine, Pipotiazine, Flufenazine, Periciazine, Clozapine, Pimozide, Perfenazine, Sertindole, Levomepromazine, Amisulpride, Asenapine, Tiapride, Droperidol, Ziprasidone.

Drug: Antipsychotic treatment
Antipsychotic treatment is not modify during the study, it is administered according to common clinical practice
Other Name: Antipsychotic drugs
Experimental: Discontinuation antipsychotic treatment
Dose reduction of antipsychotic treatment (25% every 4 weeks).
Drug: Discontinuation antipsychotic treatment
Dose reduction until withdrawal
Other Names:
  • Aripiprazole
  • Olanzapine
  • Zuclopenthixol
  • Clotiapine
  • Flupentixol
  • Risperidone
  • Sulpiride
  • Trifluoperazine
  • Haloperidol
  • Quetiapine
  • Paliperidone
  • Chlorpromazine
  • Pipotiazine
  • Flufenazine
  • Periciazine
  • Clozapine
  • Pimozide
  • Perfenazine
  • Sertindole
  • Levomepromazine
  • Amisulpride
  • Asenapine
  • Tiapride
  • Droperidol
  • Ziprasidone

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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01765829

Contacts
Contact: Clara M. Rosso Fernández, MD 0034955013414 claram.rosso.sspa@juntadeandalucia.es
Contact: Miguel Ruiz Veguilla, MD, PhD 0034955013414 mruizveguilla@yahoo.com

Locations
Spain
Mental Health Unit Villamartín Recruiting
Villamartín, Cádiz, Spain, 11650
Contact: José María Mongil San Juan, MD    0034956040209    cheman45@gmail.com   
Principal Investigator: José María Mongil San Juan, MD         
Mental Health Unit Baza Recruiting
Baza, Granada, Spain, 18800
Contact: Eva Bravo Barba, MD       eva.bravo.barba@gmail.com   
Principal Investigator: Eva Bravo Barba, MD         
Mental Health Unit Motril Recruiting
Motril, Granada, Spain, 18600
Contact: María Luisa Barrigón Estévez, MD    0034958038849    marial.barrigon.sspa@juntadeandalucia.es   
Principal Investigator: María Luisa Barrigón Estévez, MD         
Mental Health Unit Andújar Recruiting
Andújar, Jaén, Spain, 23740
Contact: Fernando Sarramea Crespo, MD, PhD    0034953021717    fernandosarramea@hotmail.com   
Principal Investigator: Farnando Sarramea Crespo, MD, PhD         
Mental Health Unit Martos Recruiting
Martos, Jaén, Spain, 23600
Contact: Miguel Ortigosa Luque, MD       migueortigosa@hotmail.com   
Principal Investigator: Miguel Ortigosa Luque, MD         
Mental Health Unit Miraflores Not yet recruiting
Alcobendas, Madrid, Spain, 28100
Contact: María Luisa Zamarro Arraz, MD, PhD    0034916530108    zamarroluisa@yahoo.es   
Principal Investigator: María Luisa Zamarro Arraz, MD, PhD         
Hospital Infanta Sofía Not yet recruiting
San Sebastian de los Reyes, Madrid, Spain, 28702
Contact: María Rosario Gutiérrez Labrador, MD       rosagutierrez@psiquiatra.e.telefonica.net   
Principal Investigator: María Rosario Guitiérrez Labrador, MD         
Mental Health Unit Valle del Guadalhorce Not yet recruiting
Cártama, Málaga, Spain, 29580
Contact: Daniel Gutiérrez Castillo, MD    0034951033931    dgutierrezcastillo@gmail.com   
Principal Investigator: Daniel Gutiérrez Castillo, MD         
Mental Health Unit Las Lagunas Not yet recruiting
Fuengiróla, Málaga, Spain, 29650
Contact: María Isabel Osuna Carmona, MD       maribelosunac@hotmail.com   
Principal Investigator: María Isabel Osuna Carmona, MD         
Fundación Argibide Not yet recruiting
Pamplona, Navarra, Spain, 31007
Contact: Ignacio Mata Pastor, MD, PhD    0034948266650    nacho.mata70@gmail.com   
Principal Investigator: Ignacio Mata Pastor, MD, PhD         
Hospital El Tomillar Recruiting
Dos Hermanas, Seville, Spain, 41700
Contact: Joaquín Carlos Martín Muñoz, MD, PhD    0034955016083    joaquinmartin@hotmail.com   
Principal Investigator: Joaquín Carlos Martín Muñoz, MD, PhD         
Hospital Francesc de Borja Recruiting
Gandía, Valencia, Spain, 46700
Contact: María Lacruz Silvestre, MD, PhD       maria.lacruz.silvestre@gmail.com   
Principal Investigator: María Lacruz Silvestre, MD, PhD         
Hospital de Basurto Not yet recruiting
Bilbao, Spain, 48013
Contact: Sonia Bustamante Madariaga, MD, Phd    0034944 006137    sonia.bustamantemadariaga@osakidetza.net   
Principal Investigator: Sonia Bustamante Madariaga, MD, PhD         
Lafora Hospital Not yet recruiting
Madrid, Spain, 28049
Contact: Juan Dios Molina Martín, MD, PhD       jmolinamar@hotmail.com   
Principal Investigator: Juan Dios Molina Martín, MD, PhD         
Mental Health Unit Tetuán Not yet recruiting
Madrid, Spain, 28003
Contact: Mariano Hernández Monsalve, MD, PhD    0034915347363    hergoico@gmail.com   
Contact: Ruth Berdún Pe, MD       ruthberdun@yahoo.es   
Principal Investigator: Mariano Hernández Monsalve, MD, PhD         
Hospital Carlos Haya Recruiting
Málaga, Spain, 29009
Contact: Fermín Mayoral Cleríes, Md, PhD       fermin.mayoral.sspa@juntadeandalucia.es   
Principal Investigator: Fermín Mayoral Cleríes, MD, PhD         
Virgen del Rocío Hospital Recruiting
Seville, Spain, 41013
Contact: Clara M. Rosso Fernández, MD    0034955013414    claram.rosso.sspa@juntadeandalucia.es   
Contact: Miguel Ruiz Veguilla, MD, PhD    0034955013414    mruizveguilla@yahoo.com   
Principal Investigator: Miguel Ruiz Veguilla, MD, PhD         
Sponsors and Collaborators
Fundación Pública Andaluza Progreso y Salud
Instituto de Salud Carlos III
Investigators
Study Chair: Miguel Ruiz Veguilla, MD, PhD Virgen del Rocío Hospital
  More Information

No publications provided

Responsible Party: Fundación Pública Andaluza Progreso y Salud
ClinicalTrials.gov Identifier: NCT01765829     History of Changes
Other Study ID Numbers: NONSTOP
Study First Received: January 3, 2013
Last Updated: January 8, 2013
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Fundación Pública Andaluza Progreso y Salud:
Non Affective Psychosis
First episode
Discontinuation scheme

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features
Chlorpromazine
Droperidol
Haloperidol
Trifluoperazine
Olanzapine
Clopenthixol
Clothiapine
Clozapine
Flupenthixol
Haloperidol decanoate
Methotrimeprazine
Perphenazine
Pimozide
Sulpiride
Tiapride Hydrochloride
Antipsychotic Agents
Risperidone
Sultopride
Sertindole
Quetiapine
9-hydroxy-risperidone
Aripiprazole
Ziprasidone
Asenapine
Flupenthixol decanoate
Antiemetics
Autonomic Agents

ClinicalTrials.gov processed this record on August 26, 2014