Clinical trial NCT01765829: Clinical Trial to Evaluate the Efficacy of Treatment vs Discontinuation in a First Episode of Non-affective Psychosis
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Psychosis Nos/Other
Keywords: Non Affective Psychosis
First episode
Discontinuation scheme
Lead sponsor: Andalusian Network for Design and Translation of Advanced Therapies
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
First posted: 2013-01-10
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Risk of relapse
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Villamartín
country: Spain
facility: Mental Health Unit Villamartín
state: Cádiz
city: Baza
country: Spain
facility: Mental Health Unit Baza
state: Granada
city: Motril
country: Spain
facility: Mental Health Unit Motril
state: Granada
city: Andújar
country: Spain
facility: Mental Health Unit Andújar
state: Jaén
city: Martos
country: Spain
facility: Mental Health Unit Martos
state: Jaén
city: Alcobendas
country: Spain
facility: Mental Health Unit Miraflores
state: Madrid
city: San Sebastian de los Reyes
country: Spain
facility: Hospital Infanta Sofía
state: Madrid
city: Cártama
country: Spain
facility: Mental Health Unit Valle del Guadalhorce
state: Málaga
city: Fuengiróla
country: Spain
facility: Mental Health Unit Las Lagunas
state: Málaga
city: Pamplona
country: Spain
facility: Fundación Argibide
state: Navarra
city: Dos Hermanas
country: Spain
facility: Hospital El Tomillar
state: Seville
city: Gandía
country: Spain
facility: Hospital Francesc de Borja
state: Valencia
city: Bilbao
country: Spain
facility: Hospital de Basurto
city: Madrid
country: Spain
facility: Mental Health Unit Tetuán
city: Madrid
country: Spain
facility: Lafora Hospital
city: Málaga
country: Spain
facility: Hospital Carlos Haya
city: Seville
country: Spain
facility: Virgen del Rocío Hospital
Study officials:
affiliation: Virgen del Rocío Hospital
name: Miguel Ruiz Veguilla, MD, PhD
role: STUDY_CHAIR
References: