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.
Verified January 2013 by Fundación Pública Andaluza Progreso y Salud
Sponsor:
Fundación Pública Andaluza Progreso y Salud
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
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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:
Drug Information available for:
Chlorpromazine
Haloperidol
Perphenazine
Chlorpromazine hydrochloride
Trifluoperazine
Trifluoperazine hydrochloride
Droperidol
Pimozide
Clozapine
Asenapine
Haloperidol decanoate
Risperidone
Quetiapine
Quetiapine fumarate
Ziprasidone hydrochloride
Aripiprazole
Olanzapine
Paliperidone
Ziprasidone
Ziprasidone mesylate
Olanzapine pamoate
U.S. FDA Resources
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:
|
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
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 Clopenthixol acetate ester Clothiapine Clozapine Flupenthixol Haloperidol decanoate Methotrimeprazine |
Perphenazine Pimozide Sulpiride Antipsychotic Agents Risperidone Sultopride Sertindole Quetiapine 9-hydroxy-risperidone Aripiprazole Ziprasidone Asenapine Flupenthixol decanoate Antiemetics Autonomic Agents |
ClinicalTrials.gov processed this record on May 19, 2013