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

NCT ID: NCT01765829

Last Updated: 2014-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2015-11-30

Brief Summary

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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

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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.

Conditions

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Psychosis Nos/Other

Keywords

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Non Affective Psychosis First episode Discontinuation scheme

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Antipsychotic treatment

Intervention Type DRUG

Antipsychotic treatment is not modify during the study, it is administered according to common clinical practice

Discontinuation antipsychotic treatment

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

Group Type EXPERIMENTAL

Discontinuation antipsychotic treatment

Intervention Type DRUG

Dose reduction until withdrawal

Interventions

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Discontinuation antipsychotic treatment

Dose reduction until withdrawal

Intervention Type DRUG

Antipsychotic treatment

Antipsychotic treatment is not modify during the study, it is administered according to common clinical practice

Intervention Type DRUG

Other Intervention Names

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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 Antipsychotic drugs

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto de Salud Carlos III

OTHER_GOV

Sponsor Role collaborator

Fundación Pública Andaluza Progreso y Salud

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Miguel Ruiz Veguilla, MD, PhD

Role: STUDY_CHAIR

Virgen del Rocío Hospital

Locations

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Hospital de Basurto

Bilbao, Bilbao, Spain

Site Status NOT_YET_RECRUITING

Mental Health Unit Villamartín

Villamartín, Cádiz, Spain

Site Status RECRUITING

Mental Health Unit Baza

Baza, Granada, Spain

Site Status RECRUITING

Mental Health Unit Motril

Motril, Granada, Spain

Site Status RECRUITING

Mental Health Unit Andújar

Andújar, Jaén, Spain

Site Status RECRUITING

Mental Health Unit Martos

Martos, Jaén, Spain

Site Status RECRUITING

Mental Health Unit Miraflores

Alcobendas, Madrid, Spain

Site Status NOT_YET_RECRUITING

Mental Health Unit Tetuán

Madrid, Madrid, Spain

Site Status NOT_YET_RECRUITING

Lafora Hospital

Madrid, Madrid, Spain

Site Status NOT_YET_RECRUITING

Hospital Infanta Sofía

San Sebastián de los Reyes, Madrid, Spain

Site Status NOT_YET_RECRUITING

Mental Health Unit Valle del Guadalhorce

Cártama, Málaga, Spain

Site Status NOT_YET_RECRUITING

Mental Health Unit Las Lagunas

Fuengiróla, Málaga, Spain

Site Status NOT_YET_RECRUITING

Hospital Carlos Haya

Málaga, Málaga, Spain

Site Status RECRUITING

Fundación Argibide

Pamplona, Navarre, Spain

Site Status NOT_YET_RECRUITING

Hospital El Tomillar

Dos Hermanas, Seville, Spain

Site Status RECRUITING

Virgen del Rocío Hospital

Seville, Seville, Spain

Site Status RECRUITING

Hospital Francesc de Borja

Gandia, Valencia, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Clara M. Rosso Fernández, MD

Role: CONTACT

Phone: 0034955013414

Email: [email protected]

Miguel Ruiz Veguilla, MD, PhD

Role: CONTACT

Phone: 0034955013414

Email: [email protected]

Facility Contacts

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Sonia Bustamante Madariaga, MD, Phd

Role: primary

José María Mongil San Juan, MD

Role: primary

Eva Bravo Barba, MD

Role: primary

María Luisa Barrigón Estévez, MD

Role: primary

Fernando Sarramea Crespo, MD, PhD

Role: primary

Miguel Ortigosa Luque, MD

Role: primary

María Luisa Zamarro Arraz, MD, PhD

Role: primary

Mariano Hernández Monsalve, MD, PhD

Role: primary

Ruth Berdún Pe, MD

Role: backup

Juan Dios Molina Martín, MD, PhD

Role: primary

María Rosario Gutiérrez Labrador, MD

Role: primary

Daniel Gutiérrez Castillo, MD

Role: primary

María Isabel Osuna Carmona, MD

Role: primary

Fermín Mayoral Cleríes, Md, PhD

Role: primary

Ignacio Mata Pastor, MD, PhD

Role: primary

Joaquín Carlos Martín Muñoz, MD, PhD

Role: primary

Clara M. Rosso Fernández, MD

Role: primary

Miguel Ruiz Veguilla, MD, PhD

Role: backup

María Lacruz Silvestre, MD, PhD

Role: primary

Other Identifiers

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NONSTOP

Identifier Type: -

Identifier Source: org_study_id