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

Psychosis Nos/Other Clinical Trial

— NONSTOP  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01765829
• Other study ID #: NONSTOP
• Status: Recruiting
• Phase: Phase 3
• First received: January 3, 2013
• Last updated: December 4, 2014
• Start date: November 2012
• Est. completion date: November 2015

Study information

• Verified date: December 2014
• Source: Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
• Contact: Clara M. Rosso Fernández, MD
• Phone: 0034955013414
• Email: claram.rosso.sspa[@]juntadeandalucia.es
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 104
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mental Disorders
• Psychosis Nos/Other
• Psychotic Disorders

Intervention

Drug:
• Discontinuation antipsychotic treatment
Dose reduction until withdrawal
• Antipsychotic treatment
Antipsychotic treatment is not modify during the study, it is administered according to common clinical practice

Locations

Country	Name	City	State
Spain	Mental Health Unit Miraflores	Alcobendas	Madrid
Spain	Mental Health Unit Andújar	Andújar	Jaén
Spain	Mental Health Unit Baza	Baza	Granada
Spain	Hospital de Basurto	Bilbao
Spain	Mental Health Unit Valle del Guadalhorce	Cártama	Málaga
Spain	Hospital El Tomillar	Dos Hermanas	Seville
Spain	Mental Health Unit Las Lagunas	Fuengiróla	Málaga
Spain	Hospital Francesc de Borja	Gandía	Valencia
Spain	Lafora Hospital	Madrid
Spain	Mental Health Unit Tetuán	Madrid
Spain	Hospital Carlos Haya	Málaga
Spain	Mental Health Unit Martos	Martos	Jaén
Spain	Mental Health Unit Motril	Motril	Granada
Spain	Fundación Argibide	Pamplona	Navarra
Spain	Hospital Infanta Sofía	San Sebastian de los Reyes	Madrid
Spain	Virgen del Rocío Hospital	Seville
Spain	Mental Health Unit Villamartín	Villamartín	Cádiz

Sponsors (2)

Lead Sponsor	Collaborator
Fundación Pública Andaluza Progreso y Salud	Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes