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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2014 by Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud.
Recruitment status was:  Recruiting
Sponsor:
Collaborator:
Instituto de Salud Carlos III
Information provided by (Responsible Party):
Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud ( Fundación Pública Andaluza Progreso y Salud )
ClinicalTrials.gov Identifier:
NCT01765829
First received: January 3, 2013
Last updated: December 4, 2014
Last verified: December 2014
  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 Andalusian Initiative for Advanced Therapies - 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 2015 (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   (Adult)
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

Locations
Spain
Mental Health Unit Villamartín
Villamartín, Cádiz, Spain, 11650
Mental Health Unit Baza
Baza, Granada, Spain, 18800
Mental Health Unit Motril
Motril, Granada, Spain, 18600
Mental Health Unit Andújar
Andújar, Jaén, Spain, 23740
Mental Health Unit Martos
Martos, Jaén, Spain, 23600
Mental Health Unit Miraflores
Alcobendas, Madrid, Spain, 28100
Hospital Infanta Sofía
San Sebastian de los Reyes, Madrid, Spain, 28702
Mental Health Unit Valle del Guadalhorce
Cártama, Málaga, Spain, 29580
Mental Health Unit Las Lagunas
Fuengiróla, Málaga, Spain, 29650
Fundación Argibide
Pamplona, Navarra, Spain, 31007
Hospital El Tomillar
Dos Hermanas, Seville, Spain, 41700
Hospital Francesc de Borja
Gandía, Valencia, Spain, 46700
Hospital de Basurto
Bilbao, Spain, 48013
Mental Health Unit Tetuán
Madrid, Spain, 28003
Lafora Hospital
Madrid, Spain, 28049
Hospital Carlos Haya
Málaga, Spain, 29009
Virgen del Rocío Hospital
Seville, Spain, 41013
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

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: December 4, 2014
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud:
Non Affective Psychosis
First episode
Discontinuation scheme

Additional relevant MeSH terms:
Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Risperidone
Clozapine
Ziprasidone
Paliperidone Palmitate
Asenapine
Antipsychotic Agents
Aripiprazole
Quetiapine Fumarate
Olanzapine
Clothiapine
Clopenthixol
Methotrimeprazine
Tiapride Hydrochloride
Trifluoperazine
Pimozide
Sulpiride
Sultopride
Droperidol
Sertindole
Haloperidol
Haloperidol decanoate
Perphenazine
Flupenthixol
Chlorpromazine
Flupenthixol decanoate
Serotonin Antagonists
Serotonin Agents

ClinicalTrials.gov processed this record on December 09, 2016