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

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ClinicalTrials.gov Identifier: NCT01765829
Recruitment Status : Unknown
Verified December 2014 by Andalusian Network for Design and Translation of Advanced Therapies ( Fundación Pública Andaluza Progreso y Salud ).
Recruitment status was:  Recruiting
First Posted : January 10, 2013
Last Update Posted : December 5, 2014
Sponsor:
Collaborator:
Instituto de Salud Carlos III
Information provided by (Responsible Party):
Andalusian Network for Design and Translation of Advanced Therapies ( Fundación Pública Andaluza Progreso y Salud )

Study Description
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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.


Condition or disease Intervention/treatment Phase
Psychosis Nos/Other Drug: Discontinuation antipsychotic treatment Drug: Antipsychotic treatment Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : November 2012
Estimated Primary Completion Date : November 2015
Estimated Study Completion Date : November 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01765829


Contacts
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Contact: Clara M. Rosso Fernández, MD 0034955013414 claram.rosso.sspa@juntadeandalucia.es
Contact: Miguel Ruiz Veguilla, MD, PhD 0034955013414 mruizveguilla@yahoo.com

Locations
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Sponsors and Collaborators
Fundación Pública Andaluza Progreso y Salud
Instituto de Salud Carlos III
Investigators
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Study Chair: Miguel Ruiz Veguilla, MD, PhD Virgen del Rocío Hospital
More Information
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Responsible Party: Fundación Pública Andaluza Progreso y Salud
ClinicalTrials.gov Identifier: NCT01765829    
Other Study ID Numbers: NONSTOP
First Posted: January 10, 2013    Key Record Dates
Last Update Posted: December 5, 2014
Last Verified: December 2014
Keywords provided by Andalusian Network for Design and Translation of Advanced Therapies ( Fundación Pública Andaluza Progreso y Salud ):
Non Affective Psychosis
First episode
Discontinuation scheme
Additional relevant MeSH terms:
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Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Droperidol
Haloperidol
Pimozide
Olanzapine
Chlorpromazine
Trifluoperazine
Risperidone
Aripiprazole
Quetiapine Fumarate
Paliperidone Palmitate
Ziprasidone
Antipsychotic Agents
 Clozapine
Asenapine
Amisulpride
Perphenazine
Sertindole
Sulpiride
Clopenthixol
Clothiapine
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Tranquilizing Agents
Central Nervous System Depressants