NCT01765829

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

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.

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 104 (estimated)
• Sponsor: Fundación Pública Andaluza Progreso y Salud · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Psychosis Nos/Other

Interventions

Type	Name	Description
DRUG	Discontinuation antipsychotic treatment	Dose reduction until withdrawal
DRUG	Antipsychotic treatment	Antipsychotic treatment is not modify during the study, it is administered according to common clinical practice

Timeline

• Start date: 2012-11-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2013-01-10
• Last updated: 2014-12-05

Locations

17 sites across 1 country: Spain