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

Primary Purpose

Psychosis Nos/Other

Status
Unknown status
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Discontinuation antipsychotic treatment
Antipsychotic treatment
Sponsored by
Fundación Pública Andaluza Progreso y Salud
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychosis Nos/Other focused on measuring Non Affective Psychosis, First episode, Discontinuation scheme

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mental Health Unit VillamartínRecruiting
  • Mental Health Unit BazaRecruiting
  • Mental Health Unit MotrilRecruiting
  • Mental Health Unit AndújarRecruiting
  • Mental Health Unit MartosRecruiting
  • Mental Health Unit Miraflores
  • Hospital Infanta Sofía
  • Mental Health Unit Valle del Guadalhorce
  • Mental Health Unit Las Lagunas
  • Fundación Argibide
  • Hospital El TomillarRecruiting
  • Hospital Francesc de BorjaRecruiting
  • Hospital de Basurto
  • Mental Health Unit Tetuán
  • Lafora Hospital
  • Hospital Carlos HayaRecruiting
  • Virgen del Rocío HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Antipsychotic treatment

Discontinuation antipsychotic treatment

Arm Description

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.

Dose reduction of antipsychotic treatment (25% every 4 weeks).

Outcomes

Primary Outcome Measures

Risk of relapse
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.

Secondary Outcome Measures

Full Information

First Posted
January 3, 2013
Last Updated
December 4, 2014
Sponsor
Fundación Pública Andaluza Progreso y Salud
Collaborators
Instituto de Salud Carlos III
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1. Study Identification

Unique Protocol Identification Number
NCT01765829
Brief Title
Clinical Trial to Evaluate the Efficacy of Treatment vs Discontinuation in a First Episode of Non-affective Psychosis
Acronym
NONSTOP
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 Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Unknown status
Study Start Date
November 2012 (undefined)
Primary Completion Date
November 2015 (Anticipated)
Study Completion Date
November 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundación Pública Andaluza Progreso y Salud
Collaborators
Instituto de Salud Carlos III

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychosis Nos/Other
Keywords
Non Affective Psychosis, First episode, Discontinuation scheme

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
104 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Antipsychotic treatment
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Discontinuation antipsychotic treatment
Arm Type
Experimental
Arm Description
Dose reduction of antipsychotic treatment (25% every 4 weeks).
Intervention Type
Drug
Intervention Name(s)
Discontinuation antipsychotic treatment
Other Intervention Name(s)
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
Intervention Description
Dose reduction until withdrawal
Intervention Type
Drug
Intervention Name(s)
Antipsychotic treatment
Other Intervention Name(s)
Antipsychotic drugs
Intervention Description
Antipsychotic treatment is not modify during the study, it is administered according to common clinical practice
Primary Outcome Measure Information:
Title
Risk of relapse
Description
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.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clara M. Rosso Fernández, MD
Phone
0034955013414
Email
claram.rosso.sspa@juntadeandalucia.es
First Name & Middle Initial & Last Name or Official Title & Degree
Miguel Ruiz Veguilla, MD, PhD
Phone
0034955013414
Email
mruizveguilla@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miguel Ruiz Veguilla, MD, PhD
Organizational Affiliation
Virgen del Rocío Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Mental Health Unit Villamartín
City
Villamartín
State/Province
Cádiz
ZIP/Postal Code
11650
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
José María Mongil San Juan, MD
Phone
0034956040209
Email
cheman45@gmail.com
First Name & Middle Initial & Last Name & Degree
José María Mongil San Juan, MD
Facility Name
Mental Health Unit Baza
City
Baza
State/Province
Granada
ZIP/Postal Code
18800
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eva Bravo Barba, MD
Email
eva.bravo.barba@gmail.com
First Name & Middle Initial & Last Name & Degree
Eva Bravo Barba, MD
Facility Name
Mental Health Unit Motril
City
Motril
State/Province
Granada
ZIP/Postal Code
18600
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
María Luisa Barrigón Estévez, MD
Phone
0034958038849
Email
marial.barrigon.sspa@juntadeandalucia.es
First Name & Middle Initial & Last Name & Degree
María Luisa Barrigón Estévez, MD
Facility Name
Mental Health Unit Andújar
City
Andújar
State/Province
Jaén
ZIP/Postal Code
23740
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fernando Sarramea Crespo, MD, PhD
Phone
0034953021717
Email
fernandosarramea@hotmail.com
First Name & Middle Initial & Last Name & Degree
Farnando Sarramea Crespo, MD, PhD
Facility Name
Mental Health Unit Martos
City
Martos
State/Province
Jaén
ZIP/Postal Code
23600
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miguel Ortigosa Luque, MD
Email
migueortigosa@hotmail.com
First Name & Middle Initial & Last Name & Degree
Miguel Ortigosa Luque, MD
Facility Name
Mental Health Unit Miraflores
City
Alcobendas
State/Province
Madrid
ZIP/Postal Code
28100
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
María Luisa Zamarro Arraz, MD, PhD
Phone
0034916530108
Email
zamarroluisa@yahoo.es
First Name & Middle Initial & Last Name & Degree
María Luisa Zamarro Arraz, MD, PhD
Facility Name
Hospital Infanta Sofía
City
San Sebastian de los Reyes
State/Province
Madrid
ZIP/Postal Code
28702
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
María Rosario Gutiérrez Labrador, MD
Email
rosagutierrez@psiquiatra.e.telefonica.net
First Name & Middle Initial & Last Name & Degree
María Rosario Guitiérrez Labrador, MD
Facility Name
Mental Health Unit Valle del Guadalhorce
City
Cártama
State/Province
Málaga
ZIP/Postal Code
29580
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Gutiérrez Castillo, MD
Phone
0034951033931
Email
dgutierrezcastillo@gmail.com
First Name & Middle Initial & Last Name & Degree
Daniel Gutiérrez Castillo, MD
Facility Name
Mental Health Unit Las Lagunas
City
Fuengiróla
State/Province
Málaga
ZIP/Postal Code
29650
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
María Isabel Osuna Carmona, MD
Email
maribelosunac@hotmail.com
First Name & Middle Initial & Last Name & Degree
María Isabel Osuna Carmona, MD
Facility Name
Fundación Argibide
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31007
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ignacio Mata Pastor, MD, PhD
Phone
0034948266650
Email
nacho.mata70@gmail.com
First Name & Middle Initial & Last Name & Degree
Ignacio Mata Pastor, MD, PhD
Facility Name
Hospital El Tomillar
City
Dos Hermanas
State/Province
Seville
ZIP/Postal Code
41700
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joaquín Carlos Martín Muñoz, MD, PhD
Phone
0034955016083
Email
joaquinmartin@hotmail.com
First Name & Middle Initial & Last Name & Degree
Joaquín Carlos Martín Muñoz, MD, PhD
Facility Name
Hospital Francesc de Borja
City
Gandía
State/Province
Valencia
ZIP/Postal Code
46700
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
María Lacruz Silvestre, MD, PhD
Email
maria.lacruz.silvestre@gmail.com
First Name & Middle Initial & Last Name & Degree
María Lacruz Silvestre, MD, PhD
Facility Name
Hospital de Basurto
City
Bilbao
ZIP/Postal Code
48013
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sonia Bustamante Madariaga, MD, Phd
Phone
0034944 006137
Email
sonia.bustamantemadariaga@osakidetza.net
First Name & Middle Initial & Last Name & Degree
Sonia Bustamante Madariaga, MD, PhD
Facility Name
Mental Health Unit Tetuán
City
Madrid
ZIP/Postal Code
28003
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mariano Hernández Monsalve, MD, PhD
Phone
0034915347363
Email
hergoico@gmail.com
First Name & Middle Initial & Last Name & Degree
Ruth Berdún Pe, MD
Email
ruthberdun@yahoo.es
First Name & Middle Initial & Last Name & Degree
Mariano Hernández Monsalve, MD, PhD
Facility Name
Lafora Hospital
City
Madrid
ZIP/Postal Code
28049
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan Dios Molina Martín, MD, PhD
Email
jmolinamar@hotmail.com
First Name & Middle Initial & Last Name & Degree
Juan Dios Molina Martín, MD, PhD
Facility Name
Hospital Carlos Haya
City
Málaga
ZIP/Postal Code
29009
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fermín Mayoral Cleríes, Md, PhD
Email
fermin.mayoral.sspa@juntadeandalucia.es
First Name & Middle Initial & Last Name & Degree
Fermín Mayoral Cleríes, MD, PhD
Facility Name
Virgen del Rocío Hospital
City
Seville
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clara M. Rosso Fernández, MD
Phone
0034955013414
Email
claram.rosso.sspa@juntadeandalucia.es
First Name & Middle Initial & Last Name & Degree
Miguel Ruiz Veguilla, MD, PhD
Phone
0034955013414
Email
mruizveguilla@yahoo.com
First Name & Middle Initial & Last Name & Degree
Miguel Ruiz Veguilla, MD, PhD

12. IPD Sharing Statement

Learn more about this trial

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

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