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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
104
Dose reduction until withdrawal
Antipsychotic treatment is not modify during the study, it is administered according to common clinical practice
Hospital de Basurto
Bilbao, Bilbao, Spain
NOT_YET_RECRUITINGMental Health Unit Villamartín
Villamartín, Cádiz, Spain
RECRUITINGMental Health Unit Baza
Baza, Granada, Spain
RECRUITINGMental Health Unit Motril
Motril, Granada, Spain
RECRUITINGMental Health Unit Andújar
Andújar, Jaén, Spain
RECRUITINGMental Health Unit Martos
Martos, Jaén, Spain
RECRUITINGMental Health Unit Miraflores
Alcobendas, Madrid, Spain
NOT_YET_RECRUITINGMental Health Unit Tetuán
Madrid, Madrid, Spain
NOT_YET_RECRUITINGLafora Hospital
Madrid, Madrid, Spain
NOT_YET_RECRUITINGHospital Infanta Sofía
San Sebastián de los Reyes, Madrid, Spain
NOT_YET_RECRUITING...and 7 more locations
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.
Time frame: 12 months
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