Psychosis Nos/Other Clinical Trial
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.
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.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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