Clinical Trial to Evaluate the Efficacy of Treatment vs Discontinuation in a First Episode of Non-affective Psychosis
NONSTOP
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.
1 other identifier
interventional
104
1 country
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Nov 2012
Typical duration for phase_3
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 3, 2013
CompletedFirst Posted
Study publicly available on registry
January 10, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedDecember 5, 2014
December 1, 2014
3 years
January 3, 2013
December 4, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
12 months
Study Arms (2)
Antipsychotic treatment
ACTIVE COMPARATORAntipsychotic 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.
Discontinuation antipsychotic treatment
EXPERIMENTALDose reduction of antipsychotic treatment (25% every 4 weeks).
Interventions
Dose reduction until withdrawal
Antipsychotic treatment is not modify during the study, it is administered according to common clinical practice
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Hospital de Basurto
Bilbao, Bilbao, 48013, Spain
Mental Health Unit Villamartín
Villamartín, Cádiz, 11650, Spain
Mental Health Unit Baza
Baza, Granada, 18800, Spain
Mental Health Unit Motril
Motril, Granada, 18600, Spain
Mental Health Unit Andújar
Andújar, Jaén, 23740, Spain
Mental Health Unit Martos
Martos, Jaén, 23600, Spain
Mental Health Unit Miraflores
Alcobendas, Madrid, 28100, Spain
Mental Health Unit Tetuán
Madrid, Madrid, 28003, Spain
Lafora Hospital
Madrid, Madrid, 28049, Spain
Hospital Infanta Sofía
San Sebastián de los Reyes, Madrid, 28702, Spain
Mental Health Unit Valle del Guadalhorce
Cártama, Málaga, 29580, Spain
Mental Health Unit Las Lagunas
Fuengiróla, Málaga, 29650, Spain
Hospital Carlos Haya
Málaga, Málaga, 29009, Spain
Fundación Argibide
Pamplona, Navarre, 31007, Spain
Hospital El Tomillar
Dos Hermanas, Seville, 41700, Spain
Virgen del Rocío Hospital
Seville, Seville, 41013, Spain
Hospital Francesc de Borja
Gandia, Valencia, 46700, Spain
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Miguel Ruiz Veguilla, MD, PhD
Virgen del Rocío Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 3, 2013
First Posted
January 10, 2013
Study Start
November 1, 2012
Primary Completion
November 1, 2015
Study Completion
November 1, 2015
Last Updated
December 5, 2014
Record last verified: 2014-12