Clinical Trial to Evaluate the Efficacy of Treatment vs Discontinuation in a First Episode of Non-affective Psychosis
NCT01765829 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 104
Last updated 2014-12-05
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.
Conditions
- Psychosis Nos/Other
Interventions
- 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
Sponsors & Collaborators
-
Instituto de Salud Carlos III
collaborator OTHER_GOV -
Fundación Pública Andaluza Progreso y Salud
lead OTHER
Principal Investigators
-
Miguel Ruiz Veguilla, MD, PhD · Virgen del Rocío Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-11-30
- Primary Completion
- 2015-11-30
- Completion
- 2015-11-30
Countries
- Spain
Study Locations
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