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

Phase 3

• Conditions: Psychosis Nos/Other
• Interventions: Drug: Antipsychotic treatment; Drug: Discontinuation antipsychotic treatment

• Registration Number: NCT01765829
• Lead Sponsor: Fundación Pública Andaluza Progreso y Salud

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.

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 Timeline

• Study Start: 2012-11
• Study First Submitted: 2013-01-03
• Study First Submitted QC: 2013-01-08
• Study First Posted: 2013-01-10
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-04
• Last Update Posted: 2014-12-05
• Primary Completion: 2015-11
• Study Completion: 2015-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 104

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Antipsychotic treatment	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.
Discontinuation antipsychotic treatment	Discontinuation antipsychotic treatment	Dose reduction of antipsychotic treatment (25% every 4 weeks).

Primary Outcome Measures

Name	Time	Method
Risk of relapse	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.

Trial Locations

Locations (17)

Mental Health Unit Miraflores; 🇪🇸 Alcobendas, Madrid, Spain

Lafora Hospital; 🇪🇸 Madrid, Spain

Hospital Infanta Sofía; 🇪🇸 San Sebastian de los Reyes, Madrid, Spain

Mental Health Unit Tetuán; 🇪🇸 Madrid, Spain

Hospital Carlos Haya; 🇪🇸 Málaga, Spain

Mental Health Unit Martos; 🇪🇸 Martos, Jaén, Spain

Fundación Argibide; 🇪🇸 Pamplona, Navarra, Spain

Hospital de Basurto; 🇪🇸 Bilbao, Spain

Hospital Francesc de Borja; 🇪🇸 Gandía, Valencia, Spain

Mental Health Unit Andújar; 🇪🇸 Andújar, Jaén, Spain

Hospital El Tomillar; 🇪🇸 Dos Hermanas, Seville, Spain

Virgen del Rocío Hospital; 🇪🇸 Seville, Spain

Mental Health Unit Baza; 🇪🇸 Baza, Granada, Spain

Mental Health Unit Motril; 🇪🇸 Motril, Granada, Spain

Mental Health Unit Villamartín; 🇪🇸 Villamartín, Cádiz, Spain

Mental Health Unit Las Lagunas; 🇪🇸 Fuengiróla, Málaga, Spain

Mental Health Unit Valle del Guadalhorce; 🇪🇸 Cártama, Málaga, Spain