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. - Discontinuation clinical trial in first episode of non-affective psychosis

Fundacion Progreso y Salud0 个研究点目标入组 0 人开始时间: 2012年2月28日最近更新: 2022年8月8日

适应症

试验速览

暂无简介。

•- Adult age 18 to 55 years old
•- Non-affective psychosis diagnosis (schizophrenia, schizoaffective, schizophreniform disorders, acute psychosis, other psychosis 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
•- Shows remission criteria (Van Os y cols., 2006)
•- Signed informed consent form
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 104
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- Not fluent in Spanish
•- Takes mood stabilizers (Lithium, antiepileptic drugs...)
•- Dependency on alcohol or other substances of abuse (cannabis, cocaíne...)
•- History of Craneo-encephalic Trauma with loss of consciousness for more than 1 hour, stroke or other CNS disorders
•- IQ less than 70
•- Suicide attempt from stabilization
•- Pregnancy or planning to become pregnant during the study

发起方

Fundacion Progreso y Salud