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

December 4, 2014 updated by: Fundación Pública Andaluza Progreso y Salud

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.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

104

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Bilbao, Spain, 48013
        • Not yet recruiting
        • Hospital de Basurto
        • Contact:
        • Principal Investigator:
          • Sonia Bustamante Madariaga, MD, PhD
      • Madrid, Spain, 28003
        • Not yet recruiting
        • Mental Health Unit Tetuán
        • Contact:
          • Mariano Hernández Monsalve, MD, PhD
          • Phone Number: 0034915347363
          • Email: hergoico@gmail.com
        • Contact:
        • Principal Investigator:
          • Mariano Hernández Monsalve, MD, PhD
      • Madrid, Spain, 28049
        • Not yet recruiting
        • Lafora Hospital
        • Contact:
        • Principal Investigator:
          • Juan Dios Molina Martín, MD, PhD
      • Málaga, Spain, 29009
      • Seville, Spain, 41013
        • Recruiting
        • Virgen del Rocio Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Miguel Ruiz Veguilla, MD, PhD
    • Cádiz
      • Villamartín, Cádiz, Spain, 11650
        • Recruiting
        • Mental Health Unit Villamartín
        • Contact:
        • Principal Investigator:
          • José María Mongil San Juan, MD
    • Granada
      • Baza, Granada, Spain, 18800
        • Recruiting
        • Mental Health Unit Baza
        • Contact:
        • Principal Investigator:
          • Eva Bravo Barba, MD
      • Motril, Granada, Spain, 18600
        • Recruiting
        • Mental Health Unit Motril
        • Contact:
        • Principal Investigator:
          • María Luisa Barrigón Estévez, MD
    • Jaén
      • Andújar, Jaén, Spain, 23740
        • Recruiting
        • Mental Health Unit Andújar
        • Contact:
        • Principal Investigator:
          • Farnando Sarramea Crespo, MD, PhD
      • Martos, Jaén, Spain, 23600
        • Recruiting
        • Mental Health Unit Martos
        • Contact:
        • Principal Investigator:
          • Miguel Ortigosa Luque, MD
    • Madrid
      • Alcobendas, Madrid, Spain, 28100
        • Not yet recruiting
        • Mental Health Unit Miraflores
        • Contact:
        • Principal Investigator:
          • María Luisa Zamarro Arraz, MD, PhD
      • San Sebastian de los Reyes, Madrid, Spain, 28702
    • Málaga
      • Cártama, Málaga, Spain, 29580
        • Not yet recruiting
        • Mental Health Unit Valle del Guadalhorce
        • Contact:
        • Principal Investigator:
          • Daniel Gutiérrez Castillo, MD
      • Fuengiróla, Málaga, Spain, 29650
        • Not yet recruiting
        • Mental Health Unit Las Lagunas
        • Contact:
        • Principal Investigator:
          • María Isabel Osuna Carmona, MD
    • Navarra
      • Pamplona, Navarra, Spain, 31007
        • Not yet recruiting
        • Fundación Argibide
        • Contact:
        • Principal Investigator:
          • Ignacio Mata Pastor, MD, PhD
    • Seville
      • Dos Hermanas, Seville, Spain, 41700
        • Recruiting
        • Hospital El Tomillar
        • Contact:
        • Principal Investigator:
          • Joaquín Carlos Martín Muñoz, MD, PhD
    • Valencia
      • Gandía, Valencia, Spain, 46700
        • Recruiting
        • Hospital Francesc de Borja
        • Contact:
        • Principal Investigator:
          • María Lacruz Silvestre, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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:
  • Paliperidone
  • Risperidone
  • Aripiprazole
  • Quetiapine
  • Olanzapine
  • Amisulpride
  • Clozapine
  • Ziprasidone
  • Chlorpromazine
  • Haloperidol
  • Levomepromazine
  • Pimozide
  • Pipotiazine
  • Trifluoperazine
  • Zuclopenthixol
  • Clotiapine
  • Flupentixol
  • Sulpiride
  • Flufenazine
  • Periciazine
  • Perfenazine
  • Sertindole
  • Asenapine
  • Tiapride
  • Droperidol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Risk of relapse
Time Frame: 12 months
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación Pública Andaluza Progreso y Salud

Collaborators

Instituto de Salud Carlos III

Investigators

  • Study Chair: Miguel Ruiz Veguilla, MD, PhD, Virgen del Rocio Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (ANTICIPATED)

November 1, 2015

Study Completion (ANTICIPATED)

November 1, 2015

Study Registration Dates

First Submitted

January 3, 2013

First Submitted That Met QC Criteria

January 8, 2013

First Posted (ESTIMATE)

January 10, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

December 5, 2014

Last Update Submitted That Met QC Criteria

December 4, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NONSTOP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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